Trial Outcomes & Findings for A Study of Atezolizumab Plus Cobimetinib and Vemurafenib Versus Placebo Plus Cobimetinib and Vemurafenib in Previously Untreated BRAFv600 Mutation-Positive Patients With Metastatic or Unresectable Locally Advanced Melanoma (NCT NCT02908672)

NCT ID: NCT02908672

Last Updated: 2025-07-20

Results Overview

PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the sum of diameters (SOD) of target lesions, taking as reference smallest sum on study, including baseline. In addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of at least 5 millimeters (mm).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

514 participants

Primary outcome timeframe

Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 33 months)

Results posted on

2025-07-20

Participant Flow

A total of 514 participants with B-Raf proto-oncogene serine/threonine kinase (BRAF) V600 mutation positive metastatic or unresectable locally advanced melanoma took part in the study. The study had 2 periods: 28-day run-in period \& a triple combination period. The study was closed early by the sponsor due to the low likelihood of OS achieving statistical significance at final analysis \& slower-than-anticipated OS event accumulation. Hence, the study was considered to be completed.

Participants received either Placebo + Cobimetinib + Vemurafenib (Pbo+Cobi+Vem) or Atezolizumab + Cobimetinib + Vemurafenib (Atezo+Cobi+Vem). 26 participants were included in pbo+cobi+vem arm for safety analysis (22 in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in pbo+cobi+vem arm received atezo \& were included in the atezo+cobi+vem arm for safety analysis.

Participant milestones

Participant milestones
Measure
Run-in - Pbo + Cobi + Vem
Participants received vemurafenib, 960 milligrams (mg) (four, 240 mg tablets), orally (PO), twice a day (BID) along with cobimetinib, 60 mg (three, 20 mg tablets) PO, once a day (QD) on Days 1 to 21 only followed by vemurafenib 960 mg (four, 240 mg tablets), PO, BID on Days 22 to 28 during the 28 day run-in period.
Run-in - Atezo + Cobi + Vem
Participants received vemurafenib, 960 mg (four, 240 mg tablets) PO, BID along with cobimetinib 60 mg (three, 20 mg tablets) PO, QD on Days 1 to 21 only followed by vemurafenib 720 mg (three, 240 mg tablets) PO, BID and vemurafenib matching placebo, PO, BID on Days 22 to 28 during the 28 day run-in period.
Triple Combination: Pbo + Cobi + Vem
After the 28-day run-in, participants received atezolizumab matching placebo as IV infusion on Days 1 and 15, cobimetinib, 60 mg (three, 20 mg tablets) PO, QD, on Days 1 to 21 and vemurafenib 960 mg (four, 240 mg tablets) PO, BID on Days 1 to 28. Study treatment was continued until investigator determined disease progression (PD), death, unacceptable toxicity, withdrawal of consent, or pregnancy, whichever occurred first.
Triple Combination: Atezo + Cobi + Vem
After the 28-day run-in period, participants received atezolizumab 840 mg as IV infusion on Days 1 and 15, cobimetinib, 60 mg (three, 20 mg tablets) PO, QD, on Days 1 to 21, vemurafenib 720 mg (three, 240 mg tablets) PO BID on Days 1 to 28, and vemurafenib placebo (1 tablet) PO BID on Days 1 to 28. Study treatment was continued until investigator determined PD, death, unacceptable toxicity, withdrawal of consent, or pregnancy, whichever occurred first.
Run-in Period
STARTED
258
256
0
0
Run-in Period
COMPLETED
234
234
0
0
Run-in Period
NOT COMPLETED
24
22
0
0
Triple Combination Period
STARTED
0
0
231
230
Triple Combination Period
COMPLETED
0
0
0
0
Triple Combination Period
NOT COMPLETED
0
0
231
230

Reasons for withdrawal

Reasons for withdrawal
Measure
Run-in - Pbo + Cobi + Vem
Participants received vemurafenib, 960 milligrams (mg) (four, 240 mg tablets), orally (PO), twice a day (BID) along with cobimetinib, 60 mg (three, 20 mg tablets) PO, once a day (QD) on Days 1 to 21 only followed by vemurafenib 960 mg (four, 240 mg tablets), PO, BID on Days 22 to 28 during the 28 day run-in period.
Run-in - Atezo + Cobi + Vem
Participants received vemurafenib, 960 mg (four, 240 mg tablets) PO, BID along with cobimetinib 60 mg (three, 20 mg tablets) PO, QD on Days 1 to 21 only followed by vemurafenib 720 mg (three, 240 mg tablets) PO, BID and vemurafenib matching placebo, PO, BID on Days 22 to 28 during the 28 day run-in period.
Triple Combination: Pbo + Cobi + Vem
After the 28-day run-in, participants received atezolizumab matching placebo as IV infusion on Days 1 and 15, cobimetinib, 60 mg (three, 20 mg tablets) PO, QD, on Days 1 to 21 and vemurafenib 960 mg (four, 240 mg tablets) PO, BID on Days 1 to 28. Study treatment was continued until investigator determined disease progression (PD), death, unacceptable toxicity, withdrawal of consent, or pregnancy, whichever occurred first.
Triple Combination: Atezo + Cobi + Vem
After the 28-day run-in period, participants received atezolizumab 840 mg as IV infusion on Days 1 and 15, cobimetinib, 60 mg (three, 20 mg tablets) PO, QD, on Days 1 to 21, vemurafenib 720 mg (three, 240 mg tablets) PO BID on Days 1 to 28, and vemurafenib placebo (1 tablet) PO BID on Days 1 to 28. Study treatment was continued until investigator determined PD, death, unacceptable toxicity, withdrawal of consent, or pregnancy, whichever occurred first.
Run-in Period
Death
12
10
0
0
Run-in Period
Lost to Follow-up
1
1
0
0
Run-in Period
Reason Not Specified
2
0
0
0
Run-in Period
Protocol Violation
1
1
0
0
Run-in Period
Study Ended by Sponsor
5
1
0
0
Run-in Period
Withdrawal by Subject
3
9
0
0
Triple Combination Period
Death
0
0
150
127
Triple Combination Period
Lost to Follow-up
0
0
6
8
Triple Combination Period
Reason Not Specified
0
0
0
1
Triple Combination Period
Physician Decision
0
0
1
1
Triple Combination Period
Study Ended by Sponsor
0
0
61
77
Triple Combination Period
Withdrawal by Subject
0
0
13
16

Baseline Characteristics

A Study of Atezolizumab Plus Cobimetinib and Vemurafenib Versus Placebo Plus Cobimetinib and Vemurafenib in Previously Untreated BRAFv600 Mutation-Positive Patients With Metastatic or Unresectable Locally Advanced Melanoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Arm A: Pbo + Cobi + Vem
n=258 Participants
Participants received vemurafenib, 960 mg (four, 240 mg tablets), PO, BID along with cobimetinib, 60 mg (three, 20 mg tablets) PO, QD on Days 1 to 21 only followed by vemurafenib 960 mg (four, 240 mg tablets), PO, BID on Days 22 to 28 during the 28 day run-in period. During triple combination period (Cycle 1 onwards), participants received atezolizumab matching placebo as IV infusion on Days 1 and 15, cobimetinib, 60 mg (three, 20 mg tablets) PO, QD, on Days 1 to 21 and vemurafenib 960 mg (four, 240 mg tablets) PO, BID on Days 1 to 28. Study treatment was continued until investigator determined PD, death, unacceptable toxicity, withdrawal of consent, or pregnancy, whichever occurred first.
Arm B: Atezo + Cobi + Vem
n=256 Participants
Participants received vemurafenib, 960 mg (four, 240 mg tablets) PO, BID along with cobimetinib 60 mg (three, 20 mg tablets) PO, QD on Days 1 to 21 only followed by vemurafenib 720 mg (three, 240 mg tablets) PO, BID and vemurafenib matching placebo, PO, BID on Days 22 to 28 during the 28 day run-in period. During triple combination period (Cycle 1 onwards), participants received atezolizumab 840 mg as IV infusion on Days 1 and 15, cobimetinib, 60 mg (three, 20 mg tablets) PO, QD, on Days 1 to 21, vemurafenib 720 mg (three, 240 mg tablets) PO BID on Days 1 to 28, and vemurafenib placebo (1 tablet) PO BID on Days 1 to 28. Study treatment was continued until investigator determined PD, death, unacceptable toxicity, withdrawal of consent, or pregnancy, whichever occurred first.
Total
n=514 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
199 Participants
n=5 Participants
195 Participants
n=7 Participants
394 Participants
n=5 Participants
Age, Categorical
>=65 years
59 Participants
n=5 Participants
61 Participants
n=7 Participants
120 Participants
n=5 Participants
Age, Continuous
53.2 years
STANDARD_DEVIATION 14.1 • n=5 Participants
54.0 years
STANDARD_DEVIATION 14.2 • n=7 Participants
53.6 years
STANDARD_DEVIATION 14.1 • n=5 Participants
Sex: Female, Male
Female
109 Participants
n=5 Participants
106 Participants
n=7 Participants
215 Participants
n=5 Participants
Sex: Female, Male
Male
149 Participants
n=5 Participants
150 Participants
n=7 Participants
299 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
20 Participants
n=5 Participants
27 Participants
n=7 Participants
47 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
225 Participants
n=5 Participants
223 Participants
n=7 Participants
448 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
13 Participants
n=5 Participants
6 Participants
n=7 Participants
19 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants
n=5 Participants
1 Participants
n=7 Participants
2 Participants
n=5 Participants
Race (NIH/OMB)
Asian
4 Participants
n=5 Participants
7 Participants
n=7 Participants
11 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
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
Race (NIH/OMB)
White
246 Participants
n=5 Participants
243 Participants
n=7 Participants
489 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
6 Participants
n=5 Participants
4 Participants
n=7 Participants
10 Participants
n=5 Participants

PRIMARY outcome

Timeframe: Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 33 months)

Population: ITT population included all randomized participants, whether or not study treatment was received.

PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the sum of diameters (SOD) of target lesions, taking as reference smallest sum on study, including baseline. In addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of at least 5 millimeters (mm).

Outcome measures

Outcome measures
Measure
Arm B: Atezo + Cobi + Vem
n=256 Participants
Participants received vemurafenib, 960 mg (four, 240 mg tablets) PO, BID along with cobimetinib 60 mg (three, 20 mg tablets) PO, QD on Days 1 to 21 only followed by vemurafenib 720 mg (three, 240 mg tablets) PO, BID and vemurafenib matching placebo, PO, BID on Days 22 to 28 during the 28 day run-in period. During triple combination period (Cycle 1 onwards), participants received atezolizumab 840 mg as IV infusion on Days 1 and 15, cobimetinib, 60 mg (three, 20 mg tablets) PO, QD, on Days 1 to 21, vemurafenib 720 mg (three, 240 mg tablets) PO BID on Days 1 to 28, and vemurafenib placebo (1 tablet) PO BID on Days 1 to 28. Study treatment was continued until investigator determined PD, death, unacceptable toxicity, withdrawal of consent, or pregnancy, whichever occurred first.
Arm A: Pbo + Cobi + Vem
n=258 Participants
Participants received vemurafenib, 960 mg (four, 240 mg tablets), PO, BID along with cobimetinib, 60 mg (three, 20 mg tablets) PO, QD on Days 1 to 21 only followed by vemurafenib 960 mg (four, 240 mg tablets), PO, BID on Days 22 to 28 during the 28 day run-in period. During triple combination period (Cycle 1 onwards), participants received atezolizumab matching placebo as IV infusion on Days 1 and 15, cobimetinib, 60 mg (three, 20 mg tablets) PO, QD, on Days 1 to 21 and vemurafenib 960 mg (four, 240 mg tablets) PO, BID on Days 1 to 28. Study treatment was continued until investigator determined PD, death, unacceptable toxicity, withdrawal of consent, or pregnancy, whichever occurred first.
Progression-Free Survival (PFS), as Determined by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
15.1 months
Interval 11.4 to 18.4
10.6 months
Interval 9.3 to 12.7

SECONDARY outcome

Timeframe: Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 33 months)

Population: ITT population included all randomized participants, whether or not study treatment was received.

PFS was defined as the time from randomization to the first occurrence of disease progression, as determined by the IRC according to RECIST v1.1, or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference smallest sum on study, including baseline. In addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of at least 5 mm.

Outcome measures

Outcome measures
Measure
Arm B: Atezo + Cobi + Vem
n=256 Participants
Participants received vemurafenib, 960 mg (four, 240 mg tablets) PO, BID along with cobimetinib 60 mg (three, 20 mg tablets) PO, QD on Days 1 to 21 only followed by vemurafenib 720 mg (three, 240 mg tablets) PO, BID and vemurafenib matching placebo, PO, BID on Days 22 to 28 during the 28 day run-in period. During triple combination period (Cycle 1 onwards), participants received atezolizumab 840 mg as IV infusion on Days 1 and 15, cobimetinib, 60 mg (three, 20 mg tablets) PO, QD, on Days 1 to 21, vemurafenib 720 mg (three, 240 mg tablets) PO BID on Days 1 to 28, and vemurafenib placebo (1 tablet) PO BID on Days 1 to 28. Study treatment was continued until investigator determined PD, death, unacceptable toxicity, withdrawal of consent, or pregnancy, whichever occurred first.
Arm A: Pbo + Cobi + Vem
n=258 Participants
Participants received vemurafenib, 960 mg (four, 240 mg tablets), PO, BID along with cobimetinib, 60 mg (three, 20 mg tablets) PO, QD on Days 1 to 21 only followed by vemurafenib 960 mg (four, 240 mg tablets), PO, BID on Days 22 to 28 during the 28 day run-in period. During triple combination period (Cycle 1 onwards), participants received atezolizumab matching placebo as IV infusion on Days 1 and 15, cobimetinib, 60 mg (three, 20 mg tablets) PO, QD, on Days 1 to 21 and vemurafenib 960 mg (four, 240 mg tablets) PO, BID on Days 1 to 28. Study treatment was continued until investigator determined PD, death, unacceptable toxicity, withdrawal of consent, or pregnancy, whichever occurred first.
PFS as Determined by Independent Review Committee (IRC) Using RECIST v1.1
16.1 months
Interval 11.3 to 18.5
12.3 months
Interval 10.8 to 14.7

SECONDARY outcome

Timeframe: Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 56 months)

Population: ITT population included all randomized participants, whether or not study treatment was received. Only participants with measurable disease at baseline were analyzed for this outcome measure.

OR rate was defined as percentage of participants with partial response (PR) or complete response (CR) on 2 consecutive occasions ≥ 4 weeks apart as determined by the investigator using RECIST v.1.1. CR was defined as the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD.

Outcome measures

Outcome measures
Measure
Arm B: Atezo + Cobi + Vem
n=255 Participants
Participants received vemurafenib, 960 mg (four, 240 mg tablets) PO, BID along with cobimetinib 60 mg (three, 20 mg tablets) PO, QD on Days 1 to 21 only followed by vemurafenib 720 mg (three, 240 mg tablets) PO, BID and vemurafenib matching placebo, PO, BID on Days 22 to 28 during the 28 day run-in period. During triple combination period (Cycle 1 onwards), participants received atezolizumab 840 mg as IV infusion on Days 1 and 15, cobimetinib, 60 mg (three, 20 mg tablets) PO, QD, on Days 1 to 21, vemurafenib 720 mg (three, 240 mg tablets) PO BID on Days 1 to 28, and vemurafenib placebo (1 tablet) PO BID on Days 1 to 28. Study treatment was continued until investigator determined PD, death, unacceptable toxicity, withdrawal of consent, or pregnancy, whichever occurred first.
Arm A: Pbo + Cobi + Vem
n=246 Participants
Participants received vemurafenib, 960 mg (four, 240 mg tablets), PO, BID along with cobimetinib, 60 mg (three, 20 mg tablets) PO, QD on Days 1 to 21 only followed by vemurafenib 960 mg (four, 240 mg tablets), PO, BID on Days 22 to 28 during the 28 day run-in period. During triple combination period (Cycle 1 onwards), participants received atezolizumab matching placebo as IV infusion on Days 1 and 15, cobimetinib, 60 mg (three, 20 mg tablets) PO, QD, on Days 1 to 21 and vemurafenib 960 mg (four, 240 mg tablets) PO, BID on Days 1 to 28. Study treatment was continued until investigator determined PD, death, unacceptable toxicity, withdrawal of consent, or pregnancy, whichever occurred first.
Percentage of Participants With Objective Response (OR), as Determined by Investigator Using RECIST V1.1
66.7 percentage of participants
65.0 percentage of participants

SECONDARY outcome

Timeframe: Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 56 months)

Population: ITT population included all randomized participants, whether or not study treatment was received. Only participants with measurable disease at baseline were analyzed for this outcome measure.

DOR was defined as the time from the first occurrence of a documented OR to PD, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference smallest sum on study, including baseline. In addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of at least 5 mm. CR was defined as the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD.

Outcome measures

Outcome measures
Measure
Arm B: Atezo + Cobi + Vem
n=255 Participants
Participants received vemurafenib, 960 mg (four, 240 mg tablets) PO, BID along with cobimetinib 60 mg (three, 20 mg tablets) PO, QD on Days 1 to 21 only followed by vemurafenib 720 mg (three, 240 mg tablets) PO, BID and vemurafenib matching placebo, PO, BID on Days 22 to 28 during the 28 day run-in period. During triple combination period (Cycle 1 onwards), participants received atezolizumab 840 mg as IV infusion on Days 1 and 15, cobimetinib, 60 mg (three, 20 mg tablets) PO, QD, on Days 1 to 21, vemurafenib 720 mg (three, 240 mg tablets) PO BID on Days 1 to 28, and vemurafenib placebo (1 tablet) PO BID on Days 1 to 28. Study treatment was continued until investigator determined PD, death, unacceptable toxicity, withdrawal of consent, or pregnancy, whichever occurred first.
Arm A: Pbo + Cobi + Vem
n=246 Participants
Participants received vemurafenib, 960 mg (four, 240 mg tablets), PO, BID along with cobimetinib, 60 mg (three, 20 mg tablets) PO, QD on Days 1 to 21 only followed by vemurafenib 960 mg (four, 240 mg tablets), PO, BID on Days 22 to 28 during the 28 day run-in period. During triple combination period (Cycle 1 onwards), participants received atezolizumab matching placebo as IV infusion on Days 1 and 15, cobimetinib, 60 mg (three, 20 mg tablets) PO, QD, on Days 1 to 21 and vemurafenib 960 mg (four, 240 mg tablets) PO, BID on Days 1 to 28. Study treatment was continued until investigator determined PD, death, unacceptable toxicity, withdrawal of consent, or pregnancy, whichever occurred first.
Duration of Response (DOR), as Determined by Investigator Using RECIST v1.1
21.0 months
Interval 16.6 to 32.2
12.6 months
Interval 10.5 to 16.7

SECONDARY outcome

Timeframe: Baseline up to death due to any cause (up to approximately 85 months)

Population: ITT population included all randomized participants, whether or not study treatment was received.

OS was defined as the time from randomization to death from any cause.

Outcome measures

Outcome measures
Measure
Arm B: Atezo + Cobi + Vem
n=256 Participants
Participants received vemurafenib, 960 mg (four, 240 mg tablets) PO, BID along with cobimetinib 60 mg (three, 20 mg tablets) PO, QD on Days 1 to 21 only followed by vemurafenib 720 mg (three, 240 mg tablets) PO, BID and vemurafenib matching placebo, PO, BID on Days 22 to 28 during the 28 day run-in period. During triple combination period (Cycle 1 onwards), participants received atezolizumab 840 mg as IV infusion on Days 1 and 15, cobimetinib, 60 mg (three, 20 mg tablets) PO, QD, on Days 1 to 21, vemurafenib 720 mg (three, 240 mg tablets) PO BID on Days 1 to 28, and vemurafenib placebo (1 tablet) PO BID on Days 1 to 28. Study treatment was continued until investigator determined PD, death, unacceptable toxicity, withdrawal of consent, or pregnancy, whichever occurred first.
Arm A: Pbo + Cobi + Vem
n=258 Participants
Participants received vemurafenib, 960 mg (four, 240 mg tablets), PO, BID along with cobimetinib, 60 mg (three, 20 mg tablets) PO, QD on Days 1 to 21 only followed by vemurafenib 960 mg (four, 240 mg tablets), PO, BID on Days 22 to 28 during the 28 day run-in period. During triple combination period (Cycle 1 onwards), participants received atezolizumab matching placebo as IV infusion on Days 1 and 15, cobimetinib, 60 mg (three, 20 mg tablets) PO, QD, on Days 1 to 21 and vemurafenib 960 mg (four, 240 mg tablets) PO, BID on Days 1 to 28. Study treatment was continued until investigator determined PD, death, unacceptable toxicity, withdrawal of consent, or pregnancy, whichever occurred first.
Overall Survival (OS)
39.0 months
Interval 29.9 to 55.3
25.8 months
Interval 22.0 to 34.6

SECONDARY outcome

Timeframe: 2 years

Population: ITT population included all randomized participants, whether or not study treatment was received.

Percentage of participants with OS which was defined as the time from randomization to death from any cause. The Kaplan-Meier approach was used to estimate 2-year landmark survival rate. The 95% CI of landmark survival rate was calculated using the standard error derived from Greenwood's formula.

Outcome measures

Outcome measures
Measure
Arm B: Atezo + Cobi + Vem
n=256 Participants
Participants received vemurafenib, 960 mg (four, 240 mg tablets) PO, BID along with cobimetinib 60 mg (three, 20 mg tablets) PO, QD on Days 1 to 21 only followed by vemurafenib 720 mg (three, 240 mg tablets) PO, BID and vemurafenib matching placebo, PO, BID on Days 22 to 28 during the 28 day run-in period. During triple combination period (Cycle 1 onwards), participants received atezolizumab 840 mg as IV infusion on Days 1 and 15, cobimetinib, 60 mg (three, 20 mg tablets) PO, QD, on Days 1 to 21, vemurafenib 720 mg (three, 240 mg tablets) PO BID on Days 1 to 28, and vemurafenib placebo (1 tablet) PO BID on Days 1 to 28. Study treatment was continued until investigator determined PD, death, unacceptable toxicity, withdrawal of consent, or pregnancy, whichever occurred first.
Arm A: Pbo + Cobi + Vem
n=258 Participants
Participants received vemurafenib, 960 mg (four, 240 mg tablets), PO, BID along with cobimetinib, 60 mg (three, 20 mg tablets) PO, QD on Days 1 to 21 only followed by vemurafenib 960 mg (four, 240 mg tablets), PO, BID on Days 22 to 28 during the 28 day run-in period. During triple combination period (Cycle 1 onwards), participants received atezolizumab matching placebo as IV infusion on Days 1 and 15, cobimetinib, 60 mg (three, 20 mg tablets) PO, QD, on Days 1 to 21 and vemurafenib 960 mg (four, 240 mg tablets) PO, BID on Days 1 to 28. Study treatment was continued until investigator determined PD, death, unacceptable toxicity, withdrawal of consent, or pregnancy, whichever occurred first.
Percentage of Participants Who Have Survived at 2 Years
61.50 percentage of participants
Interval 55.31 to 67.7
53.31 percentage of participants
Interval 47.0 to 59.62

SECONDARY outcome

Timeframe: Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 33 months)

Population: ITT population included all randomized participants, whether or not study treatment was received.

Time to deterioration in GHS/health related quality of life (HRQoL) was defined as the time from randomization to first observed ≥ 10-point decrease in EORTC QLQ-C30 linearly transformed GHS/HRQoL scale score that is sustained for two consecutive assessments or followed by death while the participant is on treatment. EORTC QLQ-C30 consists of 30 questions that assess five aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, pain), GHS/QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The GHS/QoL are scored on a 7-point scale (1=Very Poor to 7=Excellent). The obtained scores are linearly transformed to a score range of 0-100, where higher scores indicate a higher response level and better QoL.

Outcome measures

Outcome measures
Measure
Arm B: Atezo + Cobi + Vem
n=256 Participants
Participants received vemurafenib, 960 mg (four, 240 mg tablets) PO, BID along with cobimetinib 60 mg (three, 20 mg tablets) PO, QD on Days 1 to 21 only followed by vemurafenib 720 mg (three, 240 mg tablets) PO, BID and vemurafenib matching placebo, PO, BID on Days 22 to 28 during the 28 day run-in period. During triple combination period (Cycle 1 onwards), participants received atezolizumab 840 mg as IV infusion on Days 1 and 15, cobimetinib, 60 mg (three, 20 mg tablets) PO, QD, on Days 1 to 21, vemurafenib 720 mg (three, 240 mg tablets) PO BID on Days 1 to 28, and vemurafenib placebo (1 tablet) PO BID on Days 1 to 28. Study treatment was continued until investigator determined PD, death, unacceptable toxicity, withdrawal of consent, or pregnancy, whichever occurred first.
Arm A: Pbo + Cobi + Vem
n=258 Participants
Participants received vemurafenib, 960 mg (four, 240 mg tablets), PO, BID along with cobimetinib, 60 mg (three, 20 mg tablets) PO, QD on Days 1 to 21 only followed by vemurafenib 960 mg (four, 240 mg tablets), PO, BID on Days 22 to 28 during the 28 day run-in period. During triple combination period (Cycle 1 onwards), participants received atezolizumab matching placebo as IV infusion on Days 1 and 15, cobimetinib, 60 mg (three, 20 mg tablets) PO, QD, on Days 1 to 21 and vemurafenib 960 mg (four, 240 mg tablets) PO, BID on Days 1 to 28. Study treatment was continued until investigator determined PD, death, unacceptable toxicity, withdrawal of consent, or pregnancy, whichever occurred first.
Time to Deterioration in Global Health Status (GHS) Determined Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Scale Score
14.4 months
Interval 9.2 to
Upper limit of 95% CI was not estimable due to an insufficient number of participants with event.
NA months
Interval 15.0 to
Median and upper limit of 95% CI were not estimable due to an insufficient number of participants with event.

SECONDARY outcome

Timeframe: Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 33 months)

Population: ITT population included all randomized participants, whether or not study treatment was received.

Time to deterioration in PF = time from randomization to first observed ≥ 10-point decrease in EORTC QLQ-C30 linearly transformed PF scale score that is sustained for two consecutive assessments or followed by death while the participant is on treatment. EORTC QLQ-C30 consists of 30 questions that assess 5 aspects of participant functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, pain), GHS/QoL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). PF scale has 5 questions about participant's PF and daily activities (strenuous activities, long walks, short walks, bed/chair rest \& needing help with eating, dressing, washing themselves, or using the toilet). PF are scored on a 4-point scale (1=Not at All to 4=Very Much). The obtained scores are linearly transformed to a score range of 0-100, where higher scores indicate a higher response level, functioning/support.

Outcome measures

Outcome measures
Measure
Arm B: Atezo + Cobi + Vem
n=256 Participants
Participants received vemurafenib, 960 mg (four, 240 mg tablets) PO, BID along with cobimetinib 60 mg (three, 20 mg tablets) PO, QD on Days 1 to 21 only followed by vemurafenib 720 mg (three, 240 mg tablets) PO, BID and vemurafenib matching placebo, PO, BID on Days 22 to 28 during the 28 day run-in period. During triple combination period (Cycle 1 onwards), participants received atezolizumab 840 mg as IV infusion on Days 1 and 15, cobimetinib, 60 mg (three, 20 mg tablets) PO, QD, on Days 1 to 21, vemurafenib 720 mg (three, 240 mg tablets) PO BID on Days 1 to 28, and vemurafenib placebo (1 tablet) PO BID on Days 1 to 28. Study treatment was continued until investigator determined PD, death, unacceptable toxicity, withdrawal of consent, or pregnancy, whichever occurred first.
Arm A: Pbo + Cobi + Vem
n=258 Participants
Participants received vemurafenib, 960 mg (four, 240 mg tablets), PO, BID along with cobimetinib, 60 mg (three, 20 mg tablets) PO, QD on Days 1 to 21 only followed by vemurafenib 960 mg (four, 240 mg tablets), PO, BID on Days 22 to 28 during the 28 day run-in period. During triple combination period (Cycle 1 onwards), participants received atezolizumab matching placebo as IV infusion on Days 1 and 15, cobimetinib, 60 mg (three, 20 mg tablets) PO, QD, on Days 1 to 21 and vemurafenib 960 mg (four, 240 mg tablets) PO, BID on Days 1 to 28. Study treatment was continued until investigator determined PD, death, unacceptable toxicity, withdrawal of consent, or pregnancy, whichever occurred first.
Time to Deterioration in Physical Functioning (PF) Determined Using EORTC QLQ-C30 Scale Score
17.5 months
Interval 11.7 to
Upper limit of 95% CI was not estimable due to an insufficient number of participants with event.
22.4 months
Interval 15.7 to
Upper limit of 95% CI was not estimable due to an insufficient number of participants with event.

SECONDARY outcome

Timeframe: Up to approximately 85 months

Population: Safety population included all participants who received any amount of any atezolizumab, cobimetinib, or vemurafenib. 26 were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& didn't received atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis.

An AE is any untoward medical occurrence in a participant when administered a pharmaceutical product regardless of the causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product. A SAE is any significant hazard, contraindication, side effect that is fatal or life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is medically significant or requires intervention to prevent one or other of the outcomes listed above. All AEs were reported until 30 days and SAEs until 90 days after the final dose of study treatment or until initiation of subsequent anti-cancer therapy, whichever occurred first.

Outcome measures

Outcome measures
Measure
Arm B: Atezo + Cobi + Vem
n=232 Participants
Participants received vemurafenib, 960 mg (four, 240 mg tablets) PO, BID along with cobimetinib 60 mg (three, 20 mg tablets) PO, QD on Days 1 to 21 only followed by vemurafenib 720 mg (three, 240 mg tablets) PO, BID and vemurafenib matching placebo, PO, BID on Days 22 to 28 during the 28 day run-in period. During triple combination period (Cycle 1 onwards), participants received atezolizumab 840 mg as IV infusion on Days 1 and 15, cobimetinib, 60 mg (three, 20 mg tablets) PO, QD, on Days 1 to 21, vemurafenib 720 mg (three, 240 mg tablets) PO BID on Days 1 to 28, and vemurafenib placebo (1 tablet) PO BID on Days 1 to 28. Study treatment was continued until investigator determined PD, death, unacceptable toxicity, withdrawal of consent, or pregnancy, whichever occurred first.
Arm A: Pbo + Cobi + Vem
n=279 Participants
Participants received vemurafenib, 960 mg (four, 240 mg tablets), PO, BID along with cobimetinib, 60 mg (three, 20 mg tablets) PO, QD on Days 1 to 21 only followed by vemurafenib 960 mg (four, 240 mg tablets), PO, BID on Days 22 to 28 during the 28 day run-in period. During triple combination period (Cycle 1 onwards), participants received atezolizumab matching placebo as IV infusion on Days 1 and 15, cobimetinib, 60 mg (three, 20 mg tablets) PO, QD, on Days 1 to 21 and vemurafenib 960 mg (four, 240 mg tablets) PO, BID on Days 1 to 28. Study treatment was continued until investigator determined PD, death, unacceptable toxicity, withdrawal of consent, or pregnancy, whichever occurred first.
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
100 percentage of participants
99.6 percentage of participants
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
50.9 percentage of participants
43.0 percentage of participants

SECONDARY outcome

Timeframe: Pre-infusion Day 1 of Cycles 1-4; 30 minutes post-infusion Day 1 of Cycles 1 and 4; at Atezolizumab discontinuation (up to approximately 33 months) (1 Cycle = 28 days)

Population: Pharmacokinetic (PK)-evaluable population included all participants who have received any dose of atezolizumab and for whom at least one evaluable PK sample was collected. Number analyzed is the number of participants with data available for analysis at the specified timepoint.

Outcome measures

Outcome measures
Measure
Arm B: Atezo + Cobi + Vem
Participants received vemurafenib, 960 mg (four, 240 mg tablets) PO, BID along with cobimetinib 60 mg (three, 20 mg tablets) PO, QD on Days 1 to 21 only followed by vemurafenib 720 mg (three, 240 mg tablets) PO, BID and vemurafenib matching placebo, PO, BID on Days 22 to 28 during the 28 day run-in period. During triple combination period (Cycle 1 onwards), participants received atezolizumab 840 mg as IV infusion on Days 1 and 15, cobimetinib, 60 mg (three, 20 mg tablets) PO, QD, on Days 1 to 21, vemurafenib 720 mg (three, 240 mg tablets) PO BID on Days 1 to 28, and vemurafenib placebo (1 tablet) PO BID on Days 1 to 28. Study treatment was continued until investigator determined PD, death, unacceptable toxicity, withdrawal of consent, or pregnancy, whichever occurred first.
Arm A: Pbo + Cobi + Vem
n=223 Participants
Participants received vemurafenib, 960 mg (four, 240 mg tablets), PO, BID along with cobimetinib, 60 mg (three, 20 mg tablets) PO, QD on Days 1 to 21 only followed by vemurafenib 960 mg (four, 240 mg tablets), PO, BID on Days 22 to 28 during the 28 day run-in period. During triple combination period (Cycle 1 onwards), participants received atezolizumab matching placebo as IV infusion on Days 1 and 15, cobimetinib, 60 mg (three, 20 mg tablets) PO, QD, on Days 1 to 21 and vemurafenib 960 mg (four, 240 mg tablets) PO, BID on Days 1 to 28. Study treatment was continued until investigator determined PD, death, unacceptable toxicity, withdrawal of consent, or pregnancy, whichever occurred first.
Serum Concentration of Atezolizumab
Cycle 2 Day 1/Predose
102 micrograms per milliliters (ug/mL)
Standard Deviation 47.4
Serum Concentration of Atezolizumab
Cycle 1 Day 1/30 Min Postdose
281 micrograms per milliliters (ug/mL)
Standard Deviation 111
Serum Concentration of Atezolizumab
Cycle 3 Day 1/Predose
149 micrograms per milliliters (ug/mL)
Standard Deviation 61.9
Serum Concentration of Atezolizumab
Cycle 4 Day 1/Predose
181 micrograms per milliliters (ug/mL)
Standard Deviation 75.5
Serum Concentration of Atezolizumab
Cycle 4 Day 1/30 Min Postdose
431 micrograms per milliliters (ug/mL)
Standard Deviation 158
Serum Concentration of Atezolizumab
Study Drugs Discontinuation Visit
122 micrograms per milliliters (ug/mL)
Standard Deviation 97.7

SECONDARY outcome

Timeframe: Pre-dose (0 hour) and 3 to 6 hours post dose on Day 15 of Cycles 1 and 4 (1 Cycle = 28 days)

Population: The Cobi PK-evaluable population included all participants who received any dose of cobimetinib 20/40 mg and for whom at least one evaluable PK sample was collected. Number analyzed is the number of participants with data available for analysis at the specified timepoint.

Outcome measures

Outcome measures
Measure
Arm B: Atezo + Cobi + Vem
n=208 Participants
Participants received vemurafenib, 960 mg (four, 240 mg tablets) PO, BID along with cobimetinib 60 mg (three, 20 mg tablets) PO, QD on Days 1 to 21 only followed by vemurafenib 720 mg (three, 240 mg tablets) PO, BID and vemurafenib matching placebo, PO, BID on Days 22 to 28 during the 28 day run-in period. During triple combination period (Cycle 1 onwards), participants received atezolizumab 840 mg as IV infusion on Days 1 and 15, cobimetinib, 60 mg (three, 20 mg tablets) PO, QD, on Days 1 to 21, vemurafenib 720 mg (three, 240 mg tablets) PO BID on Days 1 to 28, and vemurafenib placebo (1 tablet) PO BID on Days 1 to 28. Study treatment was continued until investigator determined PD, death, unacceptable toxicity, withdrawal of consent, or pregnancy, whichever occurred first.
Arm A: Pbo + Cobi + Vem
n=218 Participants
Participants received vemurafenib, 960 mg (four, 240 mg tablets), PO, BID along with cobimetinib, 60 mg (three, 20 mg tablets) PO, QD on Days 1 to 21 only followed by vemurafenib 960 mg (four, 240 mg tablets), PO, BID on Days 22 to 28 during the 28 day run-in period. During triple combination period (Cycle 1 onwards), participants received atezolizumab matching placebo as IV infusion on Days 1 and 15, cobimetinib, 60 mg (three, 20 mg tablets) PO, QD, on Days 1 to 21 and vemurafenib 960 mg (four, 240 mg tablets) PO, BID on Days 1 to 28. Study treatment was continued until investigator determined PD, death, unacceptable toxicity, withdrawal of consent, or pregnancy, whichever occurred first.
Plasma Concentration of Cobimetinib Dose: 20/40 mg
Cycle 1 Day 15/Predose
144 mg
Standard Deviation 101
79.9 mg
Standard Deviation 72.2
Plasma Concentration of Cobimetinib Dose: 20/40 mg
Cycle 1 Day 15/3-6 Hr Postdose
216 mg
Standard Deviation 145
167 mg
Standard Deviation 116
Plasma Concentration of Cobimetinib Dose: 20/40 mg
Cycle 4 Day 15/Predose
92.3 mg
Standard Deviation 79.5
108 mg
Standard Deviation 97.5
Plasma Concentration of Cobimetinib Dose: 20/40 mg
Cycle 4 Day 15/3-6 Hr Postdose
171 mg
Standard Deviation 140
167 mg
Standard Deviation 126

SECONDARY outcome

Timeframe: Pre-dose (0 hour) and 3 to 6 hours post dose on Day 15 of Cycles 1 and 4 (1 Cycle = 28 days)

Population: The Cobi PK-evaluable population included all participants who received any dose of Cobimetinib 60 mg and for whom at least one evaluable PK sample was collected. Number analyzed is the number of participants with data available for analysis at the specified timepoint.

Outcome measures

Outcome measures
Measure
Arm B: Atezo + Cobi + Vem
n=208 Participants
Participants received vemurafenib, 960 mg (four, 240 mg tablets) PO, BID along with cobimetinib 60 mg (three, 20 mg tablets) PO, QD on Days 1 to 21 only followed by vemurafenib 720 mg (three, 240 mg tablets) PO, BID and vemurafenib matching placebo, PO, BID on Days 22 to 28 during the 28 day run-in period. During triple combination period (Cycle 1 onwards), participants received atezolizumab 840 mg as IV infusion on Days 1 and 15, cobimetinib, 60 mg (three, 20 mg tablets) PO, QD, on Days 1 to 21, vemurafenib 720 mg (three, 240 mg tablets) PO BID on Days 1 to 28, and vemurafenib placebo (1 tablet) PO BID on Days 1 to 28. Study treatment was continued until investigator determined PD, death, unacceptable toxicity, withdrawal of consent, or pregnancy, whichever occurred first.
Arm A: Pbo + Cobi + Vem
n=218 Participants
Participants received vemurafenib, 960 mg (four, 240 mg tablets), PO, BID along with cobimetinib, 60 mg (three, 20 mg tablets) PO, QD on Days 1 to 21 only followed by vemurafenib 960 mg (four, 240 mg tablets), PO, BID on Days 22 to 28 during the 28 day run-in period. During triple combination period (Cycle 1 onwards), participants received atezolizumab matching placebo as IV infusion on Days 1 and 15, cobimetinib, 60 mg (three, 20 mg tablets) PO, QD, on Days 1 to 21 and vemurafenib 960 mg (four, 240 mg tablets) PO, BID on Days 1 to 28. Study treatment was continued until investigator determined PD, death, unacceptable toxicity, withdrawal of consent, or pregnancy, whichever occurred first.
Plasma Concentration of Cobimetinib Dose: 60 mg
Cycle 1 Day 15/Predose
216 mg
Standard Deviation 188
169 mg
Standard Deviation 171
Plasma Concentration of Cobimetinib Dose: 60 mg
Cycle 1 Day 15/3-6 Hr Postdose
375 mg
Standard Deviation 243
278 mg
Standard Deviation 206
Plasma Concentration of Cobimetinib Dose: 60 mg
Cycle 4 Day 15/Predose
151 mg
Standard Deviation 120
150 mg
Standard Deviation 113
Plasma Concentration of Cobimetinib Dose: 60 mg
Cycle 4 Day 15/3-6 Hr Postdose
256 mg
Standard Deviation 197
240 mg
Standard Deviation 195

SECONDARY outcome

Timeframe: Pre-dose (0 hour) and 3 to 6 hours post dose on Day 15 of Cycles 1 and 4 (1 Cycle = 28 days)

Population: The Vem PK-evaluable population included all participants who received any dose of vemurafenib and for whom at least one evaluable PK sample was collected. Number analyzed is the number of participants with data available for analysis at the specified timepoint.

Outcome measures

Outcome measures
Measure
Arm B: Atezo + Cobi + Vem
n=209 Participants
Participants received vemurafenib, 960 mg (four, 240 mg tablets) PO, BID along with cobimetinib 60 mg (three, 20 mg tablets) PO, QD on Days 1 to 21 only followed by vemurafenib 720 mg (three, 240 mg tablets) PO, BID and vemurafenib matching placebo, PO, BID on Days 22 to 28 during the 28 day run-in period. During triple combination period (Cycle 1 onwards), participants received atezolizumab 840 mg as IV infusion on Days 1 and 15, cobimetinib, 60 mg (three, 20 mg tablets) PO, QD, on Days 1 to 21, vemurafenib 720 mg (three, 240 mg tablets) PO BID on Days 1 to 28, and vemurafenib placebo (1 tablet) PO BID on Days 1 to 28. Study treatment was continued until investigator determined PD, death, unacceptable toxicity, withdrawal of consent, or pregnancy, whichever occurred first.
Arm A: Pbo + Cobi + Vem
n=218 Participants
Participants received vemurafenib, 960 mg (four, 240 mg tablets), PO, BID along with cobimetinib, 60 mg (three, 20 mg tablets) PO, QD on Days 1 to 21 only followed by vemurafenib 960 mg (four, 240 mg tablets), PO, BID on Days 22 to 28 during the 28 day run-in period. During triple combination period (Cycle 1 onwards), participants received atezolizumab matching placebo as IV infusion on Days 1 and 15, cobimetinib, 60 mg (three, 20 mg tablets) PO, QD, on Days 1 to 21 and vemurafenib 960 mg (four, 240 mg tablets) PO, BID on Days 1 to 28. Study treatment was continued until investigator determined PD, death, unacceptable toxicity, withdrawal of consent, or pregnancy, whichever occurred first.
Plasma Concentration of Vemurafenib
Cycle 1 Day 15/ predose
27.0 μg/mL
Geometric Coefficient of Variation 102
38.9 μg/mL
Geometric Coefficient of Variation 100
Plasma Concentration of Vemurafenib
Cycle 1 Day 15/ 3-6 hr
28.0 μg/mL
Geometric Coefficient of Variation 88.6
41.3 μg/mL
Geometric Coefficient of Variation 57.7
Plasma Concentration of Vemurafenib
Cycle 4 Day 15/ predose
24.7 μg/mL
Geometric Coefficient of Variation 202
39.2 μg/mL
Geometric Coefficient of Variation 105
Plasma Concentration of Vemurafenib
Cycle 4 Day 15/ 3-6 hr postdose
26.5 μg/mL
Geometric Coefficient of Variation 135
42.3 μg/mL
Geometric Coefficient of Variation 59.4

SECONDARY outcome

Timeframe: Pre-infusion Day 1 of Cycles 1-4 (1 Cycle=28 days); at Atezolizumab discontinuation (approximately up to 33 months)

Population: The ADA-evaluable population included participants who received at least one dose of atezolizumab and had ≥ 1 post-baseline ADA result. Number analyzed is the number of participants with data available for analysis at the specified timepoint.

Presence of ADAs against atezolizumab during the study relative to the presence of ADAs at baseline. The percentage of ADA-positive participants after drug administration were determined for participants exposed to atezolizumab. For determining post-baseline incidence, participants were considered to be ADA-positive if they were ADA-negative or had missing data at baseline but developed an ADA response following study drug exposure, or if they were ADA-positive at baseline and the titer of 1 or more post-baseline samples was at least 0.60 titer units (t.u.) greater than the baseline titer result.

Outcome measures

Outcome measures
Measure
Arm B: Atezo + Cobi + Vem
Participants received vemurafenib, 960 mg (four, 240 mg tablets) PO, BID along with cobimetinib 60 mg (three, 20 mg tablets) PO, QD on Days 1 to 21 only followed by vemurafenib 720 mg (three, 240 mg tablets) PO, BID and vemurafenib matching placebo, PO, BID on Days 22 to 28 during the 28 day run-in period. During triple combination period (Cycle 1 onwards), participants received atezolizumab 840 mg as IV infusion on Days 1 and 15, cobimetinib, 60 mg (three, 20 mg tablets) PO, QD, on Days 1 to 21, vemurafenib 720 mg (three, 240 mg tablets) PO BID on Days 1 to 28, and vemurafenib placebo (1 tablet) PO BID on Days 1 to 28. Study treatment was continued until investigator determined PD, death, unacceptable toxicity, withdrawal of consent, or pregnancy, whichever occurred first.
Arm A: Pbo + Cobi + Vem
n=218 Participants
Participants received vemurafenib, 960 mg (four, 240 mg tablets), PO, BID along with cobimetinib, 60 mg (three, 20 mg tablets) PO, QD on Days 1 to 21 only followed by vemurafenib 960 mg (four, 240 mg tablets), PO, BID on Days 22 to 28 during the 28 day run-in period. During triple combination period (Cycle 1 onwards), participants received atezolizumab matching placebo as IV infusion on Days 1 and 15, cobimetinib, 60 mg (three, 20 mg tablets) PO, QD, on Days 1 to 21 and vemurafenib 960 mg (four, 240 mg tablets) PO, BID on Days 1 to 28. Study treatment was continued until investigator determined PD, death, unacceptable toxicity, withdrawal of consent, or pregnancy, whichever occurred first.
Percentage of Participants Positive for Anti-drug Antibodies (ADA) to Atezolizumab
Baseline evaluable participants
1.4 percentage of participants
Percentage of Participants Positive for Anti-drug Antibodies (ADA) to Atezolizumab
Post-baseline evaluable participants
13.3 percentage of participants

Adverse Events

Run-in - Atezo + Cobi + Vem

Serious events: 21 serious events
Other events: 208 other events
Deaths: 0 deaths

Run-in - Pbo + Cobi + Vem

Serious events: 50 serious events
Other events: 262 other events
Deaths: 25 deaths

Triple Combination: Pbo + Cobi + Vem

Serious events: 81 serious events
Other events: 222 other events
Deaths: 149 deaths

Triple Combination: Atezo + Cobi + Vem

Serious events: 109 serious events
Other events: 226 other events
Deaths: 128 deaths

Serious adverse events

Serious adverse events
Measure
Run-in - Atezo + Cobi + Vem
n=232 participants at risk
Participants received vemurafenib, 960 mg (four, 240 mg tablets) PO, BID along with cobimetinib 60 mg (three, 20 mg tablets) PO, QD on Days 1 to 21 only followed by vemurafenib 720 mg (three, 240 mg tablets) PO, BID and vemurafenib matching placebo, PO, BID on Days 22 to 28 during the 28 day run-in period.
Run-in - Pbo + Cobi + Vem
n=279 participants at risk
Participants received vemurafenib, 960 mg (four, 240 mg tablets), PO, BID along with cobimetinib, 60 mg (three, 20 mg tablets) PO, QD on Days 1 to 21 only followed by vemurafenib 960 mg (four, 240 mg tablets), PO, BID on Days 22 to 28 during the 28 day run-in period.
Triple Combination: Pbo + Cobi + Vem
n=279 participants at risk
After the 28-day run-in, participants received atezolizumab matching placebo as IV infusion on Days 1 and 15, cobimetinib, 60 mg (three, 20 mg tablets) PO, QD, on Days 1 to 21 and vemurafenib 960 mg (four, 240 mg tablets) PO, BID on Days 1 to 28. Study treatment was continued until investigator determined PD, death, unacceptable toxicity, withdrawal of consent, or pregnancy, whichever occurred first.
Triple Combination: Atezo + Cobi + Vem
n=232 participants at risk
After the 28-day run-in period, participants received atezolizumab 840 mg as IV infusion on Days 1 and 15, cobimetinib, 60 mg (three, 20 mg tablets) PO, QD, on Days 1 to 21, vemurafenib 720 mg (three, 240 mg tablets) PO BID on Days 1 to 28, and vemurafenib placebo (1 tablet) PO BID on Days 1 to 28. Study treatment was continued until investigator determined PD, death, unacceptable toxicity, withdrawal of consent, or pregnancy, whichever occurred first.
Blood and lymphatic system disorders
Agranulocytosis
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Blood and lymphatic system disorders
Leukopenia
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Blood and lymphatic system disorders
Neutropenia
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Blood and lymphatic system disorders
Thrombocytopenia
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Cardiac disorders
Acute coronary syndrome
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Cardiac disorders
Acute myocardial infarction
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Cardiac disorders
Arrhythmia
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Cardiac disorders
Atrial fibrillation
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 2 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Cardiac disorders
Bradycardia
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Cardiac disorders
Cardiac arrest
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Cardiac disorders
Cardiac failure
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
1.3%
3/232 • Number of events 3 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Cardiac disorders
Coronary artery occlusion
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Cardiac disorders
Left ventricular failure
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Cardiac disorders
Myocardial infarction
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
1.3%
3/232 • Number of events 3 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Cardiac disorders
Myocardial ischaemia
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Cardiac disorders
Palpitations
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Cardiac disorders
Pericarditis
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Cardiac disorders
Stress cardiomyopathy
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Cardiac disorders
Tachycardia
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Cardiac disorders
Ventricular arrhythmia
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Ear and labyrinth disorders
Vertigo
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.72%
2/279 • Number of events 2 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Endocrine disorders
Hyperthyroidism
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.72%
2/279 • Number of events 2 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
1.3%
3/232 • Number of events 3 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Endocrine disorders
Hypophysitis
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Eye disorders
Central serous chorioretinopathy
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Eye disorders
Detachment of retinal pigment epithelium
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Eye disorders
Eye pain
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Eye disorders
Maculopathy
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Eye disorders
Retinal artery embolism
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Eye disorders
Uveitis
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.86%
2/232 • Number of events 2 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Gastrointestinal disorders
Abdominal pain
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Gastrointestinal disorders
Autoimmune colitis
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Gastrointestinal disorders
Autoimmune pancreatitis
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 2 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Gastrointestinal disorders
Colitis
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Gastrointestinal disorders
Diarrhoea
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
1.1%
3/279 • Number of events 3 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Gastrointestinal disorders
Faecaloma
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Gastrointestinal disorders
Gastric ulcer
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Gastrointestinal disorders
Gastritis
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Gastrointestinal disorders
Gastritis erosive
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Gastrointestinal disorders
Gastrointestinal haemorrhage
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Gastrointestinal disorders
Ileus
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Gastrointestinal disorders
Intussusception
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Gastrointestinal disorders
Obstructive pancreatitis
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Gastrointestinal disorders
Oesophagitis
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Gastrointestinal disorders
Oesophagitis haemorrhagic
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Gastrointestinal disorders
Pancreatitis
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.86%
2/232 • Number of events 2 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Gastrointestinal disorders
Pancreatitis acute
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Gastrointestinal disorders
Pancreatitis necrotising
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Gastrointestinal disorders
Rectal haemorrhage
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Gastrointestinal disorders
Small intestinal obstruction
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Gastrointestinal disorders
Volvulus
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Gastrointestinal disorders
Vomiting
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
General disorders
Asthenia
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
General disorders
Chest pain
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
General disorders
Fatigue
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
General disorders
General physical health deterioration
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
1.1%
3/279 • Number of events 3 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.86%
2/232 • Number of events 2 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
General disorders
Influenza like illness
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
General disorders
Pyrexia
0.86%
2/232 • Number of events 2 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
2.5%
7/279 • Number of events 7 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
2.2%
6/279 • Number of events 7 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
5.6%
13/232 • Number of events 18 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
General disorders
Systemic inflammatory response syndrome
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Hepatobiliary disorders
Autoimmune cholangitis
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Hepatobiliary disorders
Autoimmune hepatitis
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
1.1%
3/279 • Number of events 4 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Hepatobiliary disorders
Cholangitis
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Hepatobiliary disorders
Cholecystitis
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Hepatobiliary disorders
Cholecystitis acute
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
1.3%
3/232 • Number of events 3 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Hepatobiliary disorders
Hepatic failure
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Hepatobiliary disorders
Hepatitis
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
1.7%
4/232 • Number of events 4 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Hepatobiliary disorders
Hepatitis fulminant
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Hepatobiliary disorders
Hepatotoxicity
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Hepatobiliary disorders
Hypertransaminasaemia
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Immune system disorders
Hypersensitivity
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Immune system disorders
Sarcoidosis
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Infections and infestations
Appendicitis
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Infections and infestations
Arthritis bacterial
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Infections and infestations
Atypical pneumonia
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Infections and infestations
Bacteraemia
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Infections and infestations
Bacterial infection
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 2 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Infections and infestations
Bacterial prostatitis
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Infections and infestations
Bartholin's abscess
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Infections and infestations
COVID-19
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.86%
2/232 • Number of events 2 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Infections and infestations
Cellulitis
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.86%
2/232 • Number of events 2 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Infections and infestations
Encephalitis
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Infections and infestations
Erysipelas
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.72%
2/279 • Number of events 2 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.72%
2/279 • Number of events 3 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
1.7%
4/232 • Number of events 4 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Infections and infestations
Soft tissue infection
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Infections and infestations
Gastroenteritis
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.72%
2/279 • Number of events 2 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Infections and infestations
Herpes zoster
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Infections and infestations
Infection
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.72%
2/279 • Number of events 2 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.86%
2/232 • Number of events 2 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Infections and infestations
Influenza
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.86%
2/232 • Number of events 2 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Infections and infestations
Large intestine infection
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Infections and infestations
Localised infection
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Infections and infestations
Lower respiratory tract infection
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Infections and infestations
Meningitis aseptic
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.86%
2/232 • Number of events 2 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Infections and infestations
Oral herpes
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Infections and infestations
Peritonitis
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Infections and infestations
Pharyngotonsillitis
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Infections and infestations
Pneumonia
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.72%
2/279 • Number of events 2 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
1.1%
3/279 • Number of events 3 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
3.4%
8/232 • Number of events 11 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Infections and infestations
Postoperative wound infection
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Infections and infestations
Renal abscess
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Infections and infestations
Sepsis
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.86%
2/232 • Number of events 2 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Infections and infestations
Septic shock
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Infections and infestations
Serratia bacteraemia
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Infections and infestations
Upper respiratory tract infection
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.86%
2/232 • Number of events 2 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Infections and infestations
Urinary tract infection
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.72%
2/279 • Number of events 2 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
1.3%
3/232 • Number of events 3 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Infections and infestations
Urosepsis
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Infections and infestations
Vascular device infection
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Infections and infestations
Viral infection
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Injury, poisoning and procedural complications
Face injury
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Injury, poisoning and procedural complications
Hand fracture
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.72%
2/279 • Number of events 2 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Injury, poisoning and procedural complications
Humerus fracture
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Injury, poisoning and procedural complications
Infusion related reaction
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Injury, poisoning and procedural complications
Ligament rupture
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 2 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Injury, poisoning and procedural complications
Lower limb fracture
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Injury, poisoning and procedural complications
Sternal fracture
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Investigations
Alanine aminotransferase increased
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.72%
2/279 • Number of events 2 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
2.2%
5/232 • Number of events 5 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Investigations
Aspartate aminotransferase increased
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.72%
2/279 • Number of events 2 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
1.7%
4/232 • Number of events 4 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Investigations
Blood creatine phosphokinase increased
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
1.8%
5/279 • Number of events 6 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.72%
2/279 • Number of events 2 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Investigations
Body temperature increased
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Investigations
Ejection fraction decreased
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Investigations
Electrocardiogram QT prolonged
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.86%
2/232 • Number of events 4 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Investigations
Gamma-glutamyltransferase increased
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Investigations
Hepatic enzyme increased
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Investigations
Lipase increased
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Investigations
Neutrophil count decreased
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Investigations
White blood cell count decreased
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Metabolism and nutrition disorders
Dehydration
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.72%
2/279 • Number of events 2 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Metabolism and nutrition disorders
Hyperglycaemia
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.86%
2/232 • Number of events 2 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Metabolism and nutrition disorders
Hyperkalaemia
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Metabolism and nutrition disorders
Hypoglycaemia
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Metabolism and nutrition disorders
Hypokalaemia
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Metabolism and nutrition disorders
Hyponatraemia
0.86%
2/232 • Number of events 2 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Metabolism and nutrition disorders
Metabolic acidosis
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Metabolism and nutrition disorders
Type 2 diabetes mellitus
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Musculoskeletal and connective tissue disorders
Arthralgia
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Musculoskeletal and connective tissue disorders
Back pain
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Musculoskeletal and connective tissue disorders
Fracture pain
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Musculoskeletal and connective tissue disorders
Hypercreatinaemia
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Musculoskeletal and connective tissue disorders
Muscular weakness
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Musculoskeletal and connective tissue disorders
Myositis
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Musculoskeletal and connective tissue disorders
Osteoarthritis
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Musculoskeletal and connective tissue disorders
Pathological fracture
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroma
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Keratoacanthoma
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lentigo maligna
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip neoplasm
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Liposarcoma
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.72%
2/279 • Number of events 2 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Nervous system disorders
Aphasia
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Nervous system disorders
Bell's palsy
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Nervous system disorders
Brain dislocation syndrome
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Nervous system disorders
Cerebral ischaemia
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Nervous system disorders
Cerebrovascular accident
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Nervous system disorders
Dizziness
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Nervous system disorders
Encephalitis autoimmune
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Nervous system disorders
Epilepsy
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
1.7%
4/232 • Number of events 4 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Nervous system disorders
Guillain-Barre syndrome
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.86%
2/232 • Number of events 2 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Nervous system disorders
Haemorrhage intracranial
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Nervous system disorders
Haemorrhagic stroke
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 3 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Nervous system disorders
Headache
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.72%
2/279 • Number of events 4 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Nervous system disorders
Hydrocephalus
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Nervous system disorders
Hypertonia
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Nervous system disorders
Immune-mediated encephalitis
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Nervous system disorders
Lethargy
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Nervous system disorders
Loss of consciousness
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Nervous system disorders
Peripheral sensorimotor neuropathy
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Nervous system disorders
Seizure
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.86%
2/232 • Number of events 2 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Nervous system disorders
Syncope
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
1.3%
3/232 • Number of events 3 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Nervous system disorders
Transient ischaemic attack
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Psychiatric disorders
Alcohol abuse
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Psychiatric disorders
Confusional state
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Psychiatric disorders
Delirium
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Psychiatric disorders
Mental status changes
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Renal and urinary disorders
Acute kidney injury
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
2.6%
6/232 • Number of events 6 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Renal and urinary disorders
Nephritis
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Renal and urinary disorders
Prerenal failure
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Renal and urinary disorders
Renal colic
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Renal and urinary disorders
Renal failure
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Renal and urinary disorders
Ureterolithiasis
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Reproductive system and breast disorders
Benign prostatic hyperplasia
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Reproductive system and breast disorders
Ovarian cyst
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Reproductive system and breast disorders
Ovarian rupture
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Reproductive system and breast disorders
Pelvic pain
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Reproductive system and breast disorders
Prostatitis
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
1.3%
3/232 • Number of events 3 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Respiratory, thoracic and mediastinal disorders
Haemoptysis
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Respiratory, thoracic and mediastinal disorders
Lung disorder
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Respiratory, thoracic and mediastinal disorders
Pleural effusion
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.72%
2/279 • Number of events 2 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Respiratory, thoracic and mediastinal disorders
Pneumonitis
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
1.1%
3/279 • Number of events 3 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
2.2%
5/232 • Number of events 5 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Respiratory, thoracic and mediastinal disorders
Respiratory failure
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Respiratory, thoracic and mediastinal disorders
Vocal cord leukoplakia
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Skin and subcutaneous tissue disorders
Angioedema
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Skin and subcutaneous tissue disorders
Drug reaction with eosinophilia and systemic symptoms
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.72%
2/279 • Number of events 2 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Skin and subcutaneous tissue disorders
Erythema multiforme
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.72%
2/279 • Number of events 2 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Skin and subcutaneous tissue disorders
Neutrophilic dermatosis
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Skin and subcutaneous tissue disorders
Photosensitivity reaction
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.72%
2/279 • Number of events 2 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Skin and subcutaneous tissue disorders
Purpura
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Skin and subcutaneous tissue disorders
Rash
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
1.8%
5/279 • Number of events 5 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Skin and subcutaneous tissue disorders
Rash erythematous
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Skin and subcutaneous tissue disorders
Rash maculo-papular
0.86%
2/232 • Number of events 2 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
1.4%
4/279 • Number of events 4 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Skin and subcutaneous tissue disorders
Rash papular
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Skin and subcutaneous tissue disorders
Toxic skin eruption
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Vascular disorders
Hypertension
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Vascular disorders
Hypotension
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.72%
2/279 • Number of events 2 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Vascular disorders
Shock haemorrhagic
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.

Other adverse events

Other adverse events
Measure
Run-in - Atezo + Cobi + Vem
n=232 participants at risk
Participants received vemurafenib, 960 mg (four, 240 mg tablets) PO, BID along with cobimetinib 60 mg (three, 20 mg tablets) PO, QD on Days 1 to 21 only followed by vemurafenib 720 mg (three, 240 mg tablets) PO, BID and vemurafenib matching placebo, PO, BID on Days 22 to 28 during the 28 day run-in period.
Run-in - Pbo + Cobi + Vem
n=279 participants at risk
Participants received vemurafenib, 960 mg (four, 240 mg tablets), PO, BID along with cobimetinib, 60 mg (three, 20 mg tablets) PO, QD on Days 1 to 21 only followed by vemurafenib 960 mg (four, 240 mg tablets), PO, BID on Days 22 to 28 during the 28 day run-in period.
Triple Combination: Pbo + Cobi + Vem
n=279 participants at risk
After the 28-day run-in, participants received atezolizumab matching placebo as IV infusion on Days 1 and 15, cobimetinib, 60 mg (three, 20 mg tablets) PO, QD, on Days 1 to 21 and vemurafenib 960 mg (four, 240 mg tablets) PO, BID on Days 1 to 28. Study treatment was continued until investigator determined PD, death, unacceptable toxicity, withdrawal of consent, or pregnancy, whichever occurred first.
Triple Combination: Atezo + Cobi + Vem
n=232 participants at risk
After the 28-day run-in period, participants received atezolizumab 840 mg as IV infusion on Days 1 and 15, cobimetinib, 60 mg (three, 20 mg tablets) PO, QD, on Days 1 to 21, vemurafenib 720 mg (three, 240 mg tablets) PO BID on Days 1 to 28, and vemurafenib placebo (1 tablet) PO BID on Days 1 to 28. Study treatment was continued until investigator determined PD, death, unacceptable toxicity, withdrawal of consent, or pregnancy, whichever occurred first.
Nervous system disorders
Dizziness
1.7%
4/232 • Number of events 4 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
1.4%
4/279 • Number of events 4 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
4.3%
12/279 • Number of events 13 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
6.5%
15/232 • Number of events 16 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Blood and lymphatic system disorders
Anaemia
1.3%
3/232 • Number of events 3 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
3.2%
9/279 • Number of events 11 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
13.3%
37/279 • Number of events 62 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
19.0%
44/232 • Number of events 78 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Blood and lymphatic system disorders
Lymphopenia
1.3%
3/232 • Number of events 3 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
1.1%
3/279 • Number of events 3 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
4.7%
13/279 • Number of events 19 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
7.3%
17/232 • Number of events 47 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Endocrine disorders
Hyperthyroidism
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
10.0%
28/279 • Number of events 31 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
20.7%
48/232 • Number of events 62 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Endocrine disorders
Hypothyroidism
0.86%
2/232 • Number of events 2 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
1.1%
3/279 • Number of events 3 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
8.2%
23/279 • Number of events 24 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
19.8%
46/232 • Number of events 67 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Eye disorders
Central serous chorioretinopathy
3.9%
9/232 • Number of events 9 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
6.8%
19/279 • Number of events 19 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
9.7%
27/279 • Number of events 34 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
10.8%
25/232 • Number of events 33 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Eye disorders
Dry eye
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.72%
2/279 • Number of events 2 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.72%
2/279 • Number of events 2 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
6.0%
14/232 • Number of events 15 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Eye disorders
Uveitis
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
4.3%
12/279 • Number of events 14 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
5.6%
13/232 • Number of events 18 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Eye disorders
Vision blurred
1.3%
3/232 • Number of events 3 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
2.9%
8/279 • Number of events 9 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
4.3%
12/279 • Number of events 17 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
5.2%
12/232 • Number of events 15 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Gastrointestinal disorders
Abdominal pain
1.7%
4/232 • Number of events 4 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
3.2%
9/279 • Number of events 11 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
7.9%
22/279 • Number of events 39 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
12.1%
28/232 • Number of events 44 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Gastrointestinal disorders
Abdominal pain upper
2.2%
5/232 • Number of events 5 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
3.9%
11/279 • Number of events 11 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
7.5%
21/279 • Number of events 29 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
8.6%
20/232 • Number of events 23 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Gastrointestinal disorders
Constipation
3.9%
9/232 • Number of events 10 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
7.5%
21/279 • Number of events 21 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
5.7%
16/279 • Number of events 24 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
12.9%
30/232 • Number of events 36 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Gastrointestinal disorders
Diarrhoea
33.6%
78/232 • Number of events 90 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
40.5%
113/279 • Number of events 131 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
30.5%
85/279 • Number of events 186 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
31.9%
74/232 • Number of events 196 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Gastrointestinal disorders
Dry mouth
1.3%
3/232 • Number of events 3 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.72%
2/279 • Number of events 2 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
3.6%
10/279 • Number of events 10 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
6.9%
16/232 • Number of events 17 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Gastrointestinal disorders
Dyspepsia
3.4%
8/232 • Number of events 8 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
1.8%
5/279 • Number of events 5 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
5.7%
16/279 • Number of events 23 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
6.0%
14/232 • Number of events 17 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Gastrointestinal disorders
Nausea
15.9%
37/232 • Number of events 38 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
14.7%
41/279 • Number of events 41 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
22.9%
64/279 • Number of events 96 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
23.7%
55/232 • Number of events 97 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Gastrointestinal disorders
Stomatitis
5.2%
12/232 • Number of events 15 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
2.2%
6/279 • Number of events 6 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
3.9%
11/279 • Number of events 15 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
6.5%
15/232 • Number of events 30 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Gastrointestinal disorders
Vomiting
6.9%
16/232 • Number of events 18 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
11.1%
31/279 • Number of events 31 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
16.1%
45/279 • Number of events 72 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
19.4%
45/232 • Number of events 63 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
General disorders
Asthenia
4.7%
11/232 • Number of events 12 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
6.8%
19/279 • Number of events 22 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
12.9%
36/279 • Number of events 68 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
21.6%
50/232 • Number of events 101 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
General disorders
Chills
3.4%
8/232 • Number of events 9 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
4.7%
13/279 • Number of events 13 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
3.9%
11/279 • Number of events 19 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
7.8%
18/232 • Number of events 20 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
General disorders
Fatigue
14.7%
34/232 • Number of events 35 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
13.6%
38/279 • Number of events 41 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
20.1%
56/279 • Number of events 84 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
21.6%
50/232 • Number of events 74 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
General disorders
Influenza like illness
0.86%
2/232 • Number of events 3 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
1.4%
4/279 • Number of events 4 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
4.3%
12/279 • Number of events 14 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
8.2%
19/232 • Number of events 24 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
General disorders
Mucosal inflammation
3.0%
7/232 • Number of events 7 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
1.8%
5/279 • Number of events 5 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
4.3%
12/279 • Number of events 16 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
5.2%
12/232 • Number of events 25 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
General disorders
Oedema peripheral
3.9%
9/232 • Number of events 10 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
4.7%
13/279 • Number of events 14 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
9.7%
27/279 • Number of events 36 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
19.4%
45/232 • Number of events 59 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
General disorders
Pain
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
2.9%
8/279 • Number of events 8 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
5.6%
13/232 • Number of events 14 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
General disorders
Pyrexia
19.8%
46/232 • Number of events 55 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
17.2%
48/279 • Number of events 54 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
20.8%
58/279 • Number of events 120 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
40.1%
93/232 • Number of events 203 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Infections and infestations
COVID-19
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
1.8%
5/279 • Number of events 7 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
5.6%
13/232 • Number of events 16 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Infections and infestations
Conjunctivitis
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
1.1%
3/279 • Number of events 3 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
4.7%
13/279 • Number of events 14 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
8.2%
19/232 • Number of events 21 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Infections and infestations
Folliculitis
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
4.3%
12/279 • Number of events 19 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
5.2%
12/232 • Number of events 13 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Infections and infestations
Influenza
0.86%
2/232 • Number of events 2 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
3.6%
10/279 • Number of events 13 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
7.8%
18/232 • Number of events 27 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Infections and infestations
Nasopharyngitis
1.7%
4/232 • Number of events 4 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
1.1%
3/279 • Number of events 3 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
9.7%
27/279 • Number of events 41 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
9.1%
21/232 • Number of events 41 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Infections and infestations
Upper respiratory tract infection
1.3%
3/232 • Number of events 3 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
1.4%
4/279 • Number of events 4 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
7.9%
22/279 • Number of events 23 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
9.9%
23/232 • Number of events 28 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Infections and infestations
Urinary tract infection
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
1.1%
3/279 • Number of events 3 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
3.6%
10/279 • Number of events 17 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
9.1%
21/232 • Number of events 45 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Injury, poisoning and procedural complications
Infusion related reaction
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
6.5%
18/279 • Number of events 24 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
10.3%
24/232 • Number of events 31 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Injury, poisoning and procedural complications
Sunburn
5.2%
12/232 • Number of events 14 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
3.6%
10/279 • Number of events 10 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
9.3%
26/279 • Number of events 50 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
9.1%
21/232 • Number of events 47 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Investigations
Alanine aminotransferase increased
6.0%
14/232 • Number of events 14 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
8.6%
24/279 • Number of events 25 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
18.6%
52/279 • Number of events 69 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
31.5%
73/232 • Number of events 127 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Investigations
Amylase increased
3.9%
9/232 • Number of events 9 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
6.1%
17/279 • Number of events 20 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
14.3%
40/279 • Number of events 72 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
19.8%
46/232 • Number of events 91 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Investigations
Aspartate aminotransferase increased
6.0%
14/232 • Number of events 14 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
7.2%
20/279 • Number of events 22 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
15.1%
42/279 • Number of events 61 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
28.4%
66/232 • Number of events 133 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Investigations
Blood alkaline phosphatase increased
5.6%
13/232 • Number of events 15 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
6.8%
19/279 • Number of events 20 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
11.8%
33/279 • Number of events 46 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
14.2%
33/232 • Number of events 70 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Investigations
Blood bilirubin increased
2.6%
6/232 • Number of events 6 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
2.9%
8/279 • Number of events 8 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
3.9%
11/279 • Number of events 18 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
10.3%
24/232 • Number of events 75 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Investigations
Blood creatine phosphokinase increased
20.7%
48/232 • Number of events 52 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
24.0%
67/279 • Number of events 74 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
34.4%
96/279 • Number of events 308 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
46.6%
108/232 • Number of events 328 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Investigations
Blood creatinine increased
7.3%
17/232 • Number of events 17 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
6.1%
17/279 • Number of events 17 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
12.5%
35/279 • Number of events 62 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
18.1%
42/232 • Number of events 119 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Investigations
Blood lactate dehydrogenase increased
1.7%
4/232 • Number of events 4 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
1.8%
5/279 • Number of events 5 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
3.2%
9/279 • Number of events 15 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
8.2%
19/232 • Number of events 32 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Investigations
Blood thyroid stimulating hormone increased
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
3.9%
11/279 • Number of events 12 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
5.6%
13/232 • Number of events 16 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Investigations
Ejection fraction decreased
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.72%
2/279 • Number of events 2 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
2.2%
6/279 • Number of events 6 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
5.6%
13/232 • Number of events 14 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Investigations
Gamma-glutamyltransferase increased
0.86%
2/232 • Number of events 2 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
1.8%
5/279 • Number of events 5 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
5.7%
16/279 • Number of events 21 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
6.5%
15/232 • Number of events 20 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Investigations
Lipase increased
9.1%
21/232 • Number of events 25 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
7.2%
20/279 • Number of events 27 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
26.9%
75/279 • Number of events 200 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
33.2%
77/232 • Number of events 184 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Investigations
Weight decreased
0.86%
2/232 • Number of events 2 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
2.5%
7/279 • Number of events 7 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
2.9%
8/279 • Number of events 12 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
5.6%
13/232 • Number of events 13 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Metabolism and nutrition disorders
Decreased appetite
5.2%
12/232 • Number of events 12 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
6.8%
19/279 • Number of events 20 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
9.0%
25/279 • Number of events 38 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
10.8%
25/232 • Number of events 29 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Metabolism and nutrition disorders
Hyperglycaemia
1.7%
4/232 • Number of events 4 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
2.5%
7/279 • Number of events 7 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
3.9%
11/279 • Number of events 23 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
7.8%
18/232 • Number of events 37 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Metabolism and nutrition disorders
Hypokalaemia
2.6%
6/232 • Number of events 6 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
1.4%
4/279 • Number of events 5 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
4.3%
12/279 • Number of events 17 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
5.2%
12/232 • Number of events 14 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Metabolism and nutrition disorders
Hypophosphataemia
2.2%
5/232 • Number of events 5 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
1.1%
3/279 • Number of events 3 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
5.4%
15/279 • Number of events 27 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
6.0%
14/232 • Number of events 49 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Musculoskeletal and connective tissue disorders
Arthralgia
14.2%
33/232 • Number of events 34 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
15.1%
42/279 • Number of events 48 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
25.1%
70/279 • Number of events 134 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
36.2%
84/232 • Number of events 193 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Musculoskeletal and connective tissue disorders
Back pain
0.86%
2/232 • Number of events 2 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.72%
2/279 • Number of events 2 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
6.5%
18/279 • Number of events 20 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
11.2%
26/232 • Number of events 32 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Musculoskeletal and connective tissue disorders
Muscle spasms
0.86%
2/232 • Number of events 2 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
2.9%
8/279 • Number of events 9 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
6.0%
14/232 • Number of events 18 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Musculoskeletal and connective tissue disorders
Myalgia
7.3%
17/232 • Number of events 18 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
4.3%
12/279 • Number of events 14 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
15.1%
42/279 • Number of events 62 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
22.4%
52/232 • Number of events 80 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Musculoskeletal and connective tissue disorders
Pain in extremity
3.4%
8/232 • Number of events 9 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
2.9%
8/279 • Number of events 8 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
9.0%
25/279 • Number of events 38 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
12.5%
29/232 • Number of events 51 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
0.86%
2/232 • Number of events 2 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.36%
1/279 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
5.4%
15/279 • Number of events 22 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
3.0%
7/232 • Number of events 9 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Nervous system disorders
Dysgeusia
3.0%
7/232 • Number of events 7 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
1.8%
5/279 • Number of events 5 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
2.2%
6/279 • Number of events 6 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
6.5%
15/232 • Number of events 17 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Nervous system disorders
Headache
4.7%
11/232 • Number of events 11 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
5.7%
16/279 • Number of events 16 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
16.1%
45/279 • Number of events 71 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
23.7%
55/232 • Number of events 95 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Psychiatric disorders
Insomnia
1.7%
4/232 • Number of events 4 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
1.8%
5/279 • Number of events 5 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
6.1%
17/279 • Number of events 19 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
5.6%
13/232 • Number of events 17 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Respiratory, thoracic and mediastinal disorders
Cough
0.86%
2/232 • Number of events 2 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
2.9%
8/279 • Number of events 8 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
9.3%
26/279 • Number of events 32 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
15.1%
35/232 • Number of events 63 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
1.3%
3/232 • Number of events 3 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
1.4%
4/279 • Number of events 4 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
6.5%
18/279 • Number of events 19 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
7.8%
18/232 • Number of events 28 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
2.2%
5/232 • Number of events 6 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
1.4%
4/279 • Number of events 5 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
3.6%
10/279 • Number of events 12 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
10.3%
24/232 • Number of events 26 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Respiratory, thoracic and mediastinal disorders
Pneumonitis
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.00%
0/279 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
4.7%
13/279 • Number of events 18 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
12.5%
29/232 • Number of events 36 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Skin and subcutaneous tissue disorders
Actinic keratosis
0.00%
0/232 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.72%
2/279 • Number of events 3 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
5.0%
14/279 • Number of events 22 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
1.7%
4/232 • Number of events 8 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Skin and subcutaneous tissue disorders
Alopecia
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.72%
2/279 • Number of events 2 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
9.0%
25/279 • Number of events 27 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
10.3%
24/232 • Number of events 24 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Skin and subcutaneous tissue disorders
Dermatitis acneiform
5.2%
12/232 • Number of events 13 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
10.0%
28/279 • Number of events 28 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
8.2%
23/279 • Number of events 34 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
12.5%
29/232 • Number of events 43 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Skin and subcutaneous tissue disorders
Dry skin
2.6%
6/232 • Number of events 6 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
2.5%
7/279 • Number of events 7 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
7.5%
21/279 • Number of events 24 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
12.1%
28/232 • Number of events 30 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Skin and subcutaneous tissue disorders
Erythema
4.3%
10/232 • Number of events 10 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
5.4%
15/279 • Number of events 17 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
11.8%
33/279 • Number of events 51 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
15.5%
36/232 • Number of events 42 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Skin and subcutaneous tissue disorders
Hyperkeratosis
0.43%
1/232 • Number of events 1 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
0.72%
2/279 • Number of events 2 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
2.9%
8/279 • Number of events 13 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
5.2%
12/232 • Number of events 13 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Skin and subcutaneous tissue disorders
Photosensitivity reaction
6.9%
16/232 • Number of events 16 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
14.3%
40/279 • Number of events 42 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
16.1%
45/279 • Number of events 66 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
17.2%
40/232 • Number of events 63 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Skin and subcutaneous tissue disorders
Pruritus
10.3%
24/232 • Number of events 28 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
6.5%
18/279 • Number of events 19 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
12.2%
34/279 • Number of events 66 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
22.8%
53/232 • Number of events 104 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Skin and subcutaneous tissue disorders
Rash
26.7%
62/232 • Number of events 67 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
29.0%
81/279 • Number of events 96 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
22.6%
63/279 • Number of events 106 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
30.6%
71/232 • Number of events 121 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Skin and subcutaneous tissue disorders
Rash maculo-papular
13.4%
31/232 • Number of events 34 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
15.8%
44/279 • Number of events 51 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
3.6%
10/279 • Number of events 11 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
8.2%
19/232 • Number of events 28 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
Vascular disorders
Hypertension
4.7%
11/232 • Number of events 11 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
7.5%
21/279 • Number of events 21 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
14.0%
39/279 • Number of events 52 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.
15.5%
36/232 • Number of events 45 • Run-in Period: 28 days Triple Combination Period: From the first dose of study treatment in the Triple Combination Period (Day 29) up to approximately 85 months
26 participants were included in the placebo+cobi+vem arm for safety evaluation (22 participants in atezo+cobi+vem arm stopped run-in treatment \& received no atezo \& 4 in atezo+cobi+vem arm completed the run-in treatment but did not receive atezo). During the study, 2 participants in placebo+cobi+vem arm received atezo \& were considered in the atezo+cobi+vem arm for safety analysis. Of the 26 participants who were considered in placebo for safety, 10 died and hence are shown in the placebo arm.

Additional Information

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  • 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.
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Restriction type: OTHER