Trial Outcomes & Findings for A Trial of Atezolizumab and Vigil in Patients With Advanced Gynecological Cancers (NCT NCT03073525)

NCT ID: NCT03073525

Last Updated: 2023-04-05

Results Overview

The safety evaluation included Adverse Events (AEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs) and changes from baseline in laboratory evaluations, vital signs, electrocardiograms and physical examinations. AEs were graded according to the National Cancer Institute (NCI) CTCAE v4.03 and coded using the Medical Dictionary for Regulatory Activities. Laboratory abnormalities were graded according to the NCI CTCAE v4.03, if applicable.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

25 participants

Primary outcome timeframe

AEs reported from first treatment dose and up to 30 days after last treatment, about 12 months.

Results posted on

2023-04-05

Participant Flow

Twenty-five (25) subjects signed the informed consent to enter the treatment portion of the trial. One (1) subject was ineligible, and a total of 24 subjects received treatment in the study.

Participant milestones

Participant milestones
Measure
Part 1: Vigil + Atezo
This was a safety run in and intervention was combined. The first three participants received Vigil immunotherapy at a concentration of 1x10e7 cells/dose given via intradermal injection every 3 weeks for a minimum of 4 doses and a maximum of 12 doses. Atezolizumab was administered at a dose of 1200 mg as an intravenous infusion every 3 weeks. Vigil was administered first, followed 30 minutes later by atezolizumab. 1 cycle = 21 days.
Part 2: Vigil Then Vigil + Atezo
After Part 1 participants completed combination therapy without dose-limiting toxicity, then Part 2 participants randomized to Vigil first received two cycles of Vigil alone, then Vigil and atezolizumab given in sequence. Vigil immunotherapy was administered at a concentration of 1 x 10e6 or 1 x 10e7 cells/dose given via intradermal injection every 3 weeks for a minimum of 4 doses and a maximum of 12 doses. Atezolizumab was administered at a dose of 1200 mg as an intravenous infusion every 3 weeks, with a maximum of 12 doses. When Vigil and atezolizumab was given together, Vigil was administered first, followed 30 minutes later by atezolizumab. Participants who completed all cycles of Part 2 were pre-approved by the sponsor for inclusion into Part 3. Atezolizumab alone was administered at a dose of 1200 mg as an intravenous infusion every 3 weeks. 1 cycle = 21 days
Part 2: Atezo Then Vigil + Atezo
After Part 1 participants completed combination therapy without dose-limiting toxicity, then Part 2 participants randomized to atezolizumab first received two cycles of atezolizumab alone, then Vigil and atezolizumab given in sequence. Vigil immunotherapy was administered at a concentration of 1 x 10e6 or 1 x 10e7 cells/dose given via intradermal injection every 3 weeks for a minimum of 4 doses and a maximum of 12 doses. Atezolizumab was administered at a dose of 1200 mg as an intravenous infusion every 3 weeks, with a maximum of 12 doses. When Vigil and atezolizumab was given together, Vigil was administered first, followed 30 minutes later by atezolizumab. Participants who completed all cycles of Part 2 were pre-approved by the sponsor for inclusion into Part 3. Atezolizumab alone was administered at a dose of 1200 mg as an intravenous infusion every 3 weeks. 1 cycle = 21 days
Overall Study
STARTED
3
11
10
Overall Study
Part 3: Atezolizumab Alone
0
1
0
Overall Study
COMPLETED
3
11
7
Overall Study
NOT COMPLETED
0
0
3

Reasons for withdrawal

Reasons for withdrawal
Measure
Part 1: Vigil + Atezo
This was a safety run in and intervention was combined. The first three participants received Vigil immunotherapy at a concentration of 1x10e7 cells/dose given via intradermal injection every 3 weeks for a minimum of 4 doses and a maximum of 12 doses. Atezolizumab was administered at a dose of 1200 mg as an intravenous infusion every 3 weeks. Vigil was administered first, followed 30 minutes later by atezolizumab. 1 cycle = 21 days.
Part 2: Vigil Then Vigil + Atezo
After Part 1 participants completed combination therapy without dose-limiting toxicity, then Part 2 participants randomized to Vigil first received two cycles of Vigil alone, then Vigil and atezolizumab given in sequence. Vigil immunotherapy was administered at a concentration of 1 x 10e6 or 1 x 10e7 cells/dose given via intradermal injection every 3 weeks for a minimum of 4 doses and a maximum of 12 doses. Atezolizumab was administered at a dose of 1200 mg as an intravenous infusion every 3 weeks, with a maximum of 12 doses. When Vigil and atezolizumab was given together, Vigil was administered first, followed 30 minutes later by atezolizumab. Participants who completed all cycles of Part 2 were pre-approved by the sponsor for inclusion into Part 3. Atezolizumab alone was administered at a dose of 1200 mg as an intravenous infusion every 3 weeks. 1 cycle = 21 days
Part 2: Atezo Then Vigil + Atezo
After Part 1 participants completed combination therapy without dose-limiting toxicity, then Part 2 participants randomized to atezolizumab first received two cycles of atezolizumab alone, then Vigil and atezolizumab given in sequence. Vigil immunotherapy was administered at a concentration of 1 x 10e6 or 1 x 10e7 cells/dose given via intradermal injection every 3 weeks for a minimum of 4 doses and a maximum of 12 doses. Atezolizumab was administered at a dose of 1200 mg as an intravenous infusion every 3 weeks, with a maximum of 12 doses. When Vigil and atezolizumab was given together, Vigil was administered first, followed 30 minutes later by atezolizumab. Participants who completed all cycles of Part 2 were pre-approved by the sponsor for inclusion into Part 3. Atezolizumab alone was administered at a dose of 1200 mg as an intravenous infusion every 3 weeks. 1 cycle = 21 days
Overall Study
Withdrawal by Subject
0
0
3

Baseline Characteristics

A Trial of Atezolizumab and Vigil in Patients With Advanced Gynecological Cancers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Part 1: Vigil + Atezo
n=3 Participants
This was a safety run in and intervention was combined. The first three participants received Vigil immunotherapy at a concentration of 1x10e7 cells/dose given via intradermal injection every 3 weeks for a minimum of 4 doses and a maximum of 12 doses. Atezolizumab was administered at a dose of 1200 mg as an intravenous infusion every 3 weeks. Vigil was administered first, followed 30 minutes later by atezolizumab. 1 cycle = 21 days.
Part 2: Vigil Then Vigil + Atezo
n=11 Participants
After Part 1 participants completed combination therapy without dose-limiting toxicity, then Part 2 participants randomized to Vigil first received two cycles of Vigil alone, then Vigil and atezolizumab given in sequence. Vigil immunotherapy was administered at a concentration of 1 x 10e6 or 1 x 10e7 cells/dose given via intradermal injection every 3 weeks for a minimum of 4 doses and a maximum of 12 doses. Atezolizumab was administered at a dose of 1200 mg as an intravenous infusion every 3 weeks, with a maximum of 12 doses. When Vigil and atezolizumab was given together, Vigil was administered first, followed 30 minutes later by atezolizumab. 1 cycle = 21 days
Part 2: Atezo Then Vigil + Atezo
n=10 Participants
After Part 1 participants completed combination therapy without dose-limiting toxicity, then Part 2 participants randomized to atezolizumab first received two cycles of atezolizumab alone, then Vigil and atezolizumab given in sequence. Vigil immunotherapy was administered at a concentration of 1 x 10e6 or 1 x 10e7 cells/dose given via intradermal injection every 3 weeks for a minimum of 4 doses and a maximum of 12 doses. Atezolizumab was administered at a dose of 1200 mg as an intravenous infusion every 3 weeks, with a maximum of 12 doses. When Vigil and atezolizumab was given together, Vigil was administered first, followed 30 minutes later by atezolizumab. 1 cycle = 21 days
Total
n=24 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
0 Participants
n=4 Participants
Age, Categorical
Between 18 and 65 years
2 Participants
n=5 Participants
5 Participants
n=7 Participants
7 Participants
n=5 Participants
14 Participants
n=4 Participants
Age, Categorical
>=65 years
1 Participants
n=5 Participants
6 Participants
n=7 Participants
3 Participants
n=5 Participants
10 Participants
n=4 Participants
Sex: Female, Male
Female
3 Participants
n=5 Participants
11 Participants
n=7 Participants
10 Participants
n=5 Participants
24 Participants
n=4 Participants
Sex: Female, Male
Male
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
1 Participants
n=4 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
2 Participants
n=7 Participants
1 Participants
n=5 Participants
3 Participants
n=4 Participants
Race (NIH/OMB)
White
3 Participants
n=5 Participants
9 Participants
n=7 Participants
8 Participants
n=5 Participants
20 Participants
n=4 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Region of Enrollment
United States
3 participants
n=5 Participants
11 participants
n=7 Participants
10 participants
n=5 Participants
24 participants
n=4 Participants
Number of Prior Lines of Systemic Therapies
1
0 Participants
n=5 Participants
5 Participants
n=7 Participants
2 Participants
n=5 Participants
7 Participants
n=4 Participants
Number of Prior Lines of Systemic Therapies
2
1 Participants
n=5 Participants
4 Participants
n=7 Participants
3 Participants
n=5 Participants
8 Participants
n=4 Participants
Number of Prior Lines of Systemic Therapies
3
1 Participants
n=5 Participants
2 Participants
n=7 Participants
4 Participants
n=5 Participants
7 Participants
n=4 Participants
Number of Prior Lines of Systemic Therapies
4
1 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
2 Participants
n=4 Participants
Baseline ECOG
0
2 Participants
n=5 Participants
7 Participants
n=7 Participants
2 Participants
n=5 Participants
11 Participants
n=4 Participants
Baseline ECOG
1
1 Participants
n=5 Participants
4 Participants
n=7 Participants
8 Participants
n=5 Participants
13 Participants
n=4 Participants

PRIMARY outcome

Timeframe: AEs reported from first treatment dose and up to 30 days after last treatment, about 12 months.

Population: Grade 3/4 treatment-related events from first dose up to 30 days after last treatment.

The safety evaluation included Adverse Events (AEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs) and changes from baseline in laboratory evaluations, vital signs, electrocardiograms and physical examinations. AEs were graded according to the National Cancer Institute (NCI) CTCAE v4.03 and coded using the Medical Dictionary for Regulatory Activities. Laboratory abnormalities were graded according to the NCI CTCAE v4.03, if applicable.

Outcome measures

Outcome measures
Measure
Part 1: Vigil + Atezo
n=3 Participants
This was a safety run in and intervention was combined. The first three participants received Vigil immunotherapy at a concentration of 1x10e7 cells/dose given via intradermal injection every 3 weeks for a minimum of 4 doses and a maximum of 12 doses. Atezolizumab was administered at a dose of 1200 mg as an intravenous infusion every 3 weeks. Vigil was administered first, followed 30 minutes later by atezolizumab. 1 cycle = 21 days.
Part 2: Vigil Then Vigil + Atezo
n=11 Participants
Patients in Part 1 completed combination therapy without dose-limiting toxicity justifying expansion to Part 2. This arm was to determine if Vigil given first then combined with atezolizumab would enhance immunotherapeutic anticancer activity. Overall, efficacy of administration sequence was assessed. Vigil immunotherapy was administered at a concentration of 1 x 10e6 or 1 x 10e7 cells/dose given via intradermal injection every 3 weeks for a minimum of 4 doses and a maximum of 12 doses. Atezolizumab was administered at a dose of 1200 mg as an intravenous infusion every 3 weeks, with a maximum of 12 doses. When Vigil and atezolizumab was given together, Vigil was administered first, followed 30 minutes later by atezolizumab. 1 cycle = 21 days
Part 2: Atezo Then Vigil + Atezo
n=10 Participants
Patients in Part 1 completed combination therapy without dose-limiting toxicity justifying expansion to Part 2. This arm was to determine if atezolizumab given first then combined with Vigil would enhance immunotherapeutic anticancer activity. Overall, efficacy of administration sequence was assessed. Vigil immunotherapy was administered at a concentration of 1 x 10e6 or 1 x 10e7 cells/dose given via intradermal injection every 3 weeks for a minimum of 4 doses and a maximum of 12 doses. Atezolizumab was administered at a dose of 1200 mg as an intravenous infusion every 3 weeks, with a maximum of 12 doses. When Vigil and atezolizumab was given together, Vigil was administered first, followed 30 minutes later by atezolizumab. 1 cycle = 21 days
Number of Treatment-emergent AEs of Vigil + Atezolizumab
Grade 4 Atezolizumab-Related
0 adverse events
0 adverse events
0 adverse events
Number of Treatment-emergent AEs of Vigil + Atezolizumab
Grade 4 Vigil-Related
0 adverse events
0 adverse events
0 adverse events
Number of Treatment-emergent AEs of Vigil + Atezolizumab
Grade 3 Atezolizumab-Related
0 adverse events
1 adverse events
4 adverse events
Number of Treatment-emergent AEs of Vigil + Atezolizumab
Grade 3 Vigil-Related
0 adverse events
0 adverse events
0 adverse events

SECONDARY outcome

Timeframe: Up to 30 days after last treatment

Population: Samples were not analyzed for immune response data.

Whole blood for correlative studies will be obtained at baseline, at the start of cycle 3 (the first cycle of combination therapy), every 3 cycles thereafter and end of treatment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From baseline (prior to treatment) up to 3 years

Population: All treated participants

Overall assessment of time to progression and survival will be measured by Radiological Tumor Assessment by local investigators using the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. In Part 1, disease progression was assessed at baseline and every third cycle thereafter. In Part 2, the disease was assessed at baseline, at the end of Cycle 2 of single-agent therapy, and every third cycle thereafter.

Outcome measures

Outcome measures
Measure
Part 1: Vigil + Atezo
n=3 Participants
This was a safety run in and intervention was combined. The first three participants received Vigil immunotherapy at a concentration of 1x10e7 cells/dose given via intradermal injection every 3 weeks for a minimum of 4 doses and a maximum of 12 doses. Atezolizumab was administered at a dose of 1200 mg as an intravenous infusion every 3 weeks. Vigil was administered first, followed 30 minutes later by atezolizumab. 1 cycle = 21 days.
Part 2: Vigil Then Vigil + Atezo
n=11 Participants
Patients in Part 1 completed combination therapy without dose-limiting toxicity justifying expansion to Part 2. This arm was to determine if Vigil given first then combined with atezolizumab would enhance immunotherapeutic anticancer activity. Overall, efficacy of administration sequence was assessed. Vigil immunotherapy was administered at a concentration of 1 x 10e6 or 1 x 10e7 cells/dose given via intradermal injection every 3 weeks for a minimum of 4 doses and a maximum of 12 doses. Atezolizumab was administered at a dose of 1200 mg as an intravenous infusion every 3 weeks, with a maximum of 12 doses. When Vigil and atezolizumab was given together, Vigil was administered first, followed 30 minutes later by atezolizumab. 1 cycle = 21 days
Part 2: Atezo Then Vigil + Atezo
n=10 Participants
Patients in Part 1 completed combination therapy without dose-limiting toxicity justifying expansion to Part 2. This arm was to determine if atezolizumab given first then combined with Vigil would enhance immunotherapeutic anticancer activity. Overall, efficacy of administration sequence was assessed. Vigil immunotherapy was administered at a concentration of 1 x 10e6 or 1 x 10e7 cells/dose given via intradermal injection every 3 weeks for a minimum of 4 doses and a maximum of 12 doses. Atezolizumab was administered at a dose of 1200 mg as an intravenous infusion every 3 weeks, with a maximum of 12 doses. When Vigil and atezolizumab was given together, Vigil was administered first, followed 30 minutes later by atezolizumab. 1 cycle = 21 days
Time to Progression
3.42 months
Interval 1.61 to
Not Reached
3.42 months
Interval 3.3 to
Not Reached
2.86 months
Interval 2.5 to
Not Reached

SECONDARY outcome

Timeframe: From first dose to end of study treatment (up to 9 months)

Population: All treated participants

Radiographic ORR is defined as the percentage of participants achieving a Complete Response (CR) or Partial Response (PR), as assessed by investigators using RECIST 1.1. In Part 1, ORR was assessed at baseline and every third cycle thereafter. In Part 2, the disease was assessed at baseline, at the end of Cycle 2 of single-agent therapy, and every third cycle thereafter. 95% confidence interval from exact binomial distribution (Blopper-Pearson method).

Outcome measures

Outcome measures
Measure
Part 1: Vigil + Atezo
n=3 Participants
This was a safety run in and intervention was combined. The first three participants received Vigil immunotherapy at a concentration of 1x10e7 cells/dose given via intradermal injection every 3 weeks for a minimum of 4 doses and a maximum of 12 doses. Atezolizumab was administered at a dose of 1200 mg as an intravenous infusion every 3 weeks. Vigil was administered first, followed 30 minutes later by atezolizumab. 1 cycle = 21 days.
Part 2: Vigil Then Vigil + Atezo
n=11 Participants
Patients in Part 1 completed combination therapy without dose-limiting toxicity justifying expansion to Part 2. This arm was to determine if Vigil given first then combined with atezolizumab would enhance immunotherapeutic anticancer activity. Overall, efficacy of administration sequence was assessed. Vigil immunotherapy was administered at a concentration of 1 x 10e6 or 1 x 10e7 cells/dose given via intradermal injection every 3 weeks for a minimum of 4 doses and a maximum of 12 doses. Atezolizumab was administered at a dose of 1200 mg as an intravenous infusion every 3 weeks, with a maximum of 12 doses. When Vigil and atezolizumab was given together, Vigil was administered first, followed 30 minutes later by atezolizumab. 1 cycle = 21 days
Part 2: Atezo Then Vigil + Atezo
n=10 Participants
Patients in Part 1 completed combination therapy without dose-limiting toxicity justifying expansion to Part 2. This arm was to determine if atezolizumab given first then combined with Vigil would enhance immunotherapeutic anticancer activity. Overall, efficacy of administration sequence was assessed. Vigil immunotherapy was administered at a concentration of 1 x 10e6 or 1 x 10e7 cells/dose given via intradermal injection every 3 weeks for a minimum of 4 doses and a maximum of 12 doses. Atezolizumab was administered at a dose of 1200 mg as an intravenous infusion every 3 weeks, with a maximum of 12 doses. When Vigil and atezolizumab was given together, Vigil was administered first, followed 30 minutes later by atezolizumab. 1 cycle = 21 days
Radiographic Overall Response Rate (ORR)
33 percentage of participants with response
Interval 0.8 to 90.6
9 percentage of participants with response
Interval 0.2 to 41.3
10 percentage of participants with response
Interval 0.03 to 44.5

SECONDARY outcome

Timeframe: OS will be evaluated from time of randomization up to 37 months following documented disease progression.

Population: All treated participants.

OS is defined as time of randomization to date of death due to any cause.

Outcome measures

Outcome measures
Measure
Part 1: Vigil + Atezo
n=3 Participants
This was a safety run in and intervention was combined. The first three participants received Vigil immunotherapy at a concentration of 1x10e7 cells/dose given via intradermal injection every 3 weeks for a minimum of 4 doses and a maximum of 12 doses. Atezolizumab was administered at a dose of 1200 mg as an intravenous infusion every 3 weeks. Vigil was administered first, followed 30 minutes later by atezolizumab. 1 cycle = 21 days.
Part 2: Vigil Then Vigil + Atezo
n=11 Participants
Patients in Part 1 completed combination therapy without dose-limiting toxicity justifying expansion to Part 2. This arm was to determine if Vigil given first then combined with atezolizumab would enhance immunotherapeutic anticancer activity. Overall, efficacy of administration sequence was assessed. Vigil immunotherapy was administered at a concentration of 1 x 10e6 or 1 x 10e7 cells/dose given via intradermal injection every 3 weeks for a minimum of 4 doses and a maximum of 12 doses. Atezolizumab was administered at a dose of 1200 mg as an intravenous infusion every 3 weeks, with a maximum of 12 doses. When Vigil and atezolizumab was given together, Vigil was administered first, followed 30 minutes later by atezolizumab. 1 cycle = 21 days
Part 2: Atezo Then Vigil + Atezo
n=10 Participants
Patients in Part 1 completed combination therapy without dose-limiting toxicity justifying expansion to Part 2. This arm was to determine if atezolizumab given first then combined with Vigil would enhance immunotherapeutic anticancer activity. Overall, efficacy of administration sequence was assessed. Vigil immunotherapy was administered at a concentration of 1 x 10e6 or 1 x 10e7 cells/dose given via intradermal injection every 3 weeks for a minimum of 4 doses and a maximum of 12 doses. Atezolizumab was administered at a dose of 1200 mg as an intravenous infusion every 3 weeks, with a maximum of 12 doses. When Vigil and atezolizumab was given together, Vigil was administered first, followed 30 minutes later by atezolizumab. 1 cycle = 21 days
Overall Survival (OS)
8.2 Months
Interval 5.78 to
Not enough patients have had an event
37.0 Months
Interval 18.5 to
Not enough patients have had an event
15.1 Months
Interval 5.22 to
Not enough patients have had an event

Adverse Events

Part 1: Vigil + Atezo

Serious events: 2 serious events
Other events: 2 other events
Deaths: 3 deaths

Part 2: Vigil

Serious events: 2 serious events
Other events: 9 other events
Deaths: 2 deaths

Part 2: Atezo

Serious events: 4 serious events
Other events: 10 other events
Deaths: 3 deaths

Part 2: Vigil and Atezo

Serious events: 1 serious events
Other events: 15 other events
Deaths: 9 deaths

Part 3: Atezo

Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure
Part 1: Vigil + Atezo
n=3 participants at risk
This was a safety run in and intervention was combined. The first three participants received Vigil immunotherapy at a concentration of 1x10e7 cells/dose given via intradermal injection every 3 weeks for a minimum of 4 doses and a maximum of 12 doses. Atezolizumab was administered at a dose of 1200 mg as an intravenous infusion every 3 weeks. Vigil was administered first, followed 30 minutes later by atezolizumab. 1 cycle = 21 days.
Part 2: Vigil
n=11 participants at risk
Part 2 participants randomized to Vigil first received Vigil immunotherapy at a concentration of 1 x 10e6 or 1 x 10e7 cells/dose given via intradermal injection for the first two cycles. 1 cycle = 21 days
Part 2: Atezo
n=10 participants at risk
Part 2 participants randomized to atezolizumab first received atezolizumab at a dose of 1200 mg as an intravenous infusion for the first two cycles. 1 cycle = 21 days
Part 2: Vigil and Atezo
n=21 participants at risk
After Part 2 participants completed the first two cycles of Vigil or atezolizumab, then Vigil and atezolizumab was given in sequence. Vigil immunotherapy was administered at a concentration of 1 x 10e6 or 1 x 10e7 cells/dose given via intradermal injection every 3 weeks for a minimum of 4 doses and a maximum of 12 doses. Atezolizumab was administered at a dose of 1200 mg as an intravenous infusion every 3 weeks, with a maximum of 12 doses. Vigil was administered first, followed 30 minutes later by atezolizumab. 1 cycle = 21 days
Part 3: Atezo
n=1 participants at risk
Participants continue on single agent atezolizumab until disease progression. Atezolizumab was administered at a dose of 1200 mg as an intravenous infusion. 1 cycle = 21 days.
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
33.3%
1/3 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/10 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/21 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Gastrointestinal disorders
Abdominal Pain
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
9.1%
1/11 • Number of events 2 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
10.0%
1/10 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/21 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Gastrointestinal disorders
Ascites
33.3%
1/3 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/10 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/21 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
General disorders
Fever
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
10.0%
1/10 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/21 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Gastrointestinal disorders
Small Bowel Obstruction
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
10.0%
1/10 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
4.8%
1/21 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Gastrointestinal disorders
Partial Small Intestinal Obstruction
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
10.0%
1/10 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/21 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
General disorders
Weakness
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
10.0%
1/10 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/21 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Investigations
Increased Creatinine
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
10.0%
1/10 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/21 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Injury, poisoning and procedural complications
Infusion Reaction
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
10.0%
1/10 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/21 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
General disorders
Pain
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
9.1%
1/11 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/10 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/21 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Respiratory, thoracic and mediastinal disorders
Pneumonitis
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
10.0%
1/10 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/21 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Vascular disorders
Thromboembolic Event
33.3%
1/3 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/10 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/21 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Nervous system disorders
TIA
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
10.0%
1/10 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/21 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.

Other adverse events

Other adverse events
Measure
Part 1: Vigil + Atezo
n=3 participants at risk
This was a safety run in and intervention was combined. The first three participants received Vigil immunotherapy at a concentration of 1x10e7 cells/dose given via intradermal injection every 3 weeks for a minimum of 4 doses and a maximum of 12 doses. Atezolizumab was administered at a dose of 1200 mg as an intravenous infusion every 3 weeks. Vigil was administered first, followed 30 minutes later by atezolizumab. 1 cycle = 21 days.
Part 2: Vigil
n=11 participants at risk
Part 2 participants randomized to Vigil first received Vigil immunotherapy at a concentration of 1 x 10e6 or 1 x 10e7 cells/dose given via intradermal injection for the first two cycles. 1 cycle = 21 days
Part 2: Atezo
n=10 participants at risk
Part 2 participants randomized to atezolizumab first received atezolizumab at a dose of 1200 mg as an intravenous infusion for the first two cycles. 1 cycle = 21 days
Part 2: Vigil and Atezo
n=21 participants at risk
After Part 2 participants completed the first two cycles of Vigil or atezolizumab, then Vigil and atezolizumab was given in sequence. Vigil immunotherapy was administered at a concentration of 1 x 10e6 or 1 x 10e7 cells/dose given via intradermal injection every 3 weeks for a minimum of 4 doses and a maximum of 12 doses. Atezolizumab was administered at a dose of 1200 mg as an intravenous infusion every 3 weeks, with a maximum of 12 doses. Vigil was administered first, followed 30 minutes later by atezolizumab. 1 cycle = 21 days
Part 3: Atezo
n=1 participants at risk
Participants continue on single agent atezolizumab until disease progression. Atezolizumab was administered at a dose of 1200 mg as an intravenous infusion. 1 cycle = 21 days.
Blood and lymphatic system disorders
Anemia
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
18.2%
2/11 • Number of events 2 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
20.0%
2/10 • Number of events 6 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
9.5%
2/21 • Number of events 5 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Blood and lymphatic system disorders
Leukopenia
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
10.0%
1/10 • Number of events 2 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/21 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Blood and lymphatic system disorders
Neutropenia
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
10.0%
1/10 • Number of events 2 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/21 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Blood and lymphatic system disorders
Thrombocytopenia
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
20.0%
2/10 • Number of events 2 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
9.5%
2/21 • Number of events 2 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Cardiac disorders
Tachycardia
33.3%
1/3 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/10 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/21 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Cardiac disorders
Atrial fibrillation
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
10.0%
1/10 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/21 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Ear and labyrinth disorders
Hearing impaired
33.3%
1/3 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/10 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/21 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Endocrine disorders
Goiter nodular
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
10.0%
1/10 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/21 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Endocrine disorders
Hypothyroidism
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/10 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
4.8%
1/21 • Number of events 2 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Eye disorders
Dry eyes
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/10 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
4.8%
1/21 • Number of events 2 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Gastrointestinal disorders
Abdominal distension
33.3%
1/3 • Number of events 5 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/10 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
4.8%
1/21 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Gastrointestinal disorders
Abdominal pain
66.7%
2/3 • Number of events 3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
9.1%
1/11 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
20.0%
2/10 • Number of events 2 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
33.3%
7/21 • Number of events 8 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Gastrointestinal disorders
Ascites
33.3%
1/3 • Number of events 5 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
9.1%
1/11 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/10 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
4.8%
1/21 • Number of events 3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Gastrointestinal disorders
Constipation
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
20.0%
2/10 • Number of events 2 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
4.8%
1/21 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Gastrointestinal disorders
Diarrhea
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
27.3%
3/11 • Number of events 3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
20.0%
2/10 • Number of events 2 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
4.8%
1/21 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Gastrointestinal disorders
Dyspepsia
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/10 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
4.8%
1/21 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Gastrointestinal disorders
Gastrointestinal discomfort
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
9.1%
1/11 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/10 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/21 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Gastrointestinal disorders
Hemorrhoidal hemorrhage
33.3%
1/3 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
9.1%
1/11 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/10 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/21 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Gastrointestinal disorders
Mucositis oral
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/10 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
4.8%
1/21 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Gastrointestinal disorders
Nausea
33.3%
1/3 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
63.6%
7/11 • Number of events 8 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
20.0%
2/10 • Number of events 2 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
19.0%
4/21 • Number of events 6 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Gastrointestinal disorders
Oral pain
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/10 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/21 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
100.0%
1/1 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Gastrointestinal disorders
Sore mouth
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
9.1%
1/11 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/10 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/21 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Gastrointestinal disorders
Swallowing difficult
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
10.0%
1/10 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/21 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Gastrointestinal disorders
Toothache
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/10 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
4.8%
1/21 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Gastrointestinal disorders
Vomiting
33.3%
1/3 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
18.2%
2/11 • Number of events 2 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/10 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/21 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
General disorders
Axillary pain
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/10 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
4.8%
1/21 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
General disorders
Edema extremities
33.3%
1/3 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
10.0%
1/10 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/21 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
General disorders
Fatigue
33.3%
1/3 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
18.2%
2/11 • Number of events 2 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
30.0%
3/10 • Number of events 6 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
33.3%
7/21 • Number of events 7 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
General disorders
Fever
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
20.0%
2/10 • Number of events 2 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
4.8%
1/21 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
General disorders
Flu like symptoms
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
9.1%
1/11 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/10 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
19.0%
4/21 • Number of events 4 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
General disorders
Heat intolerance
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
10.0%
1/10 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/21 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
General disorders
Injection site reaction
33.3%
1/3 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
9.1%
1/11 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/10 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/21 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
General disorders
Pain
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
9.1%
1/11 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/10 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/21 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Infections and infestations
Acute cystitis
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
10.0%
1/10 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/21 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Infections and infestations
Thrush
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
10.0%
1/10 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/21 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Infections and infestations
Urinary tract infection
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
9.1%
1/11 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/10 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/21 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Injury, poisoning and procedural complications
Incision site pain
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/10 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
4.8%
1/21 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
100.0%
1/1 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Investigations
ALT increased
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/10 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
4.8%
1/21 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Investigations
AST increased
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/10 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
4.8%
1/21 • Number of events 2 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Investigations
BUN increased
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
9.1%
1/11 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/10 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/21 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Investigations
Carbon dioxide decreased
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
9.1%
1/11 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/10 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/21 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Investigations
Creatinine increased
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
20.0%
2/10 • Number of events 3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
4.8%
1/21 • Number of events 6 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Investigations
Lymphocyte count decreased
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
10.0%
1/10 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
4.8%
1/21 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Investigations
ST segment elevated
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
10.0%
1/10 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/21 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Investigations
Weight loss
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/10 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
4.8%
1/21 • Number of events 2 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Metabolism and nutrition disorders
Acidemia
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
9.1%
1/11 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/10 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/21 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Metabolism and nutrition disorders
Anorexia
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/10 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
9.5%
2/21 • Number of events 3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Metabolism and nutrition disorders
Decreased appetite
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
10.0%
1/10 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/21 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Metabolism and nutrition disorders
Dehydration
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
18.2%
2/11 • Number of events 2 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
20.0%
2/10 • Number of events 2 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
4.8%
1/21 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Metabolism and nutrition disorders
Hypercholesterolemia
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
10.0%
1/10 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/21 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Metabolism and nutrition disorders
Hyperglycemia
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
10.0%
1/10 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/21 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Metabolism and nutrition disorders
Hyperkalemia
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/10 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
4.8%
1/21 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Metabolism and nutrition disorders
Hypoalbuminemia
33.3%
1/3 • Number of events 2 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/10 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/21 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Metabolism and nutrition disorders
Hypocalcemia
33.3%
1/3 • Number of events 3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/10 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/21 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Metabolism and nutrition disorders
Hypokalemia
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
10.0%
1/10 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
9.5%
2/21 • Number of events 2 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Metabolism and nutrition disorders
Hyponatremia
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
9.1%
1/11 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
20.0%
2/10 • Number of events 2 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/21 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Metabolism and nutrition disorders
Hypophosphatemia
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
18.2%
2/11 • Number of events 2 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/10 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/21 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Musculoskeletal and connective tissue disorders
Arthralgia
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
9.1%
1/11 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
10.0%
1/10 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
4.8%
1/21 • Number of events 3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Musculoskeletal and connective tissue disorders
Back pain
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
20.0%
2/10 • Number of events 2 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
9.5%
2/21 • Number of events 2 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Musculoskeletal and connective tissue disorders
Jaw pain
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/10 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/21 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
100.0%
1/1 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Musculoskeletal and connective tissue disorders
Muscle cramps
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
9.1%
1/11 • Number of events 2 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/10 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
9.5%
2/21 • Number of events 4 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Musculoskeletal and connective tissue disorders
Myalgia
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
10.0%
1/10 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
4.8%
1/21 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Musculoskeletal and connective tissue disorders
Neck pain
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
20.0%
2/10 • Number of events 2 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
4.8%
1/21 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Musculoskeletal and connective tissue disorders
Pain in extremity
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
10.0%
1/10 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/21 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Nervous system disorders
Dizziness
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
9.1%
1/11 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/10 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/21 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Nervous system disorders
Dysgeusia
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/10 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
9.5%
2/21 • Number of events 2 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Nervous system disorders
Headache
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
20.0%
2/10 • Number of events 2 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
4.8%
1/21 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Nervous system disorders
Intermittent headache
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/10 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
4.8%
1/21 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Nervous system disorders
Paresthesia
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
9.1%
1/11 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/10 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/21 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Nervous system disorders
Peripheral neuropathy
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
10.0%
1/10 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/21 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Nervous system disorders
Peripheral sensory neuropathy
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
10.0%
1/10 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
9.5%
2/21 • Number of events 4 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Psychiatric disorders
Anxiety reaction
33.3%
1/3 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/10 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/21 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Psychiatric disorders
Depression
33.3%
1/3 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
10.0%
1/10 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
4.8%
1/21 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Renal and urinary disorders
Acute kidney injury
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
18.2%
2/11 • Number of events 2 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/10 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/21 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Renal and urinary disorders
Chronic kidney disease
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/10 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
4.8%
1/21 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Renal and urinary disorders
Nephritis
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/10 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
4.8%
1/21 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Renal and urinary disorders
Urinary frequency
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/10 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
4.8%
1/21 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Renal and urinary disorders
Urinary tract obstruction
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/10 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
4.8%
1/21 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Reproductive system and breast disorders
Pelvic pain
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/10 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
4.8%
1/21 • Number of events 2 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Respiratory, thoracic and mediastinal disorders
Aspiration pneumonia
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
10.0%
1/10 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/21 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/10 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
4.8%
1/21 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Respiratory, thoracic and mediastinal disorders
Cough
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
10.0%
1/10 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/21 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Respiratory, thoracic and mediastinal disorders
Dry cough
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/10 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
4.8%
1/21 • Number of events 4 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Respiratory, thoracic and mediastinal disorders
Dyspnea
33.3%
1/3 • Number of events 3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
18.2%
2/11 • Number of events 2 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
40.0%
4/10 • Number of events 4 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
14.3%
3/21 • Number of events 5 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Respiratory, thoracic and mediastinal disorders
Dyspnea exertional
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
10.0%
1/10 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/21 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Respiratory, thoracic and mediastinal disorders
Epistaxis
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
9.1%
1/11 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/10 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/21 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Respiratory, thoracic and mediastinal disorders
Hypoxia
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
10.0%
1/10 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/21 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Respiratory, thoracic and mediastinal disorders
Pleural effusion
33.3%
1/3 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/10 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/21 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Respiratory, thoracic and mediastinal disorders
Productive cough
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/10 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
4.8%
1/21 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Respiratory, thoracic and mediastinal disorders
Wheezing
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/10 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
4.8%
1/21 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Skin and subcutaneous tissue disorders
Alopecia
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/10 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/21 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
100.0%
1/1 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Skin and subcutaneous tissue disorders
Itching
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
9.1%
1/11 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/10 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/21 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Skin and subcutaneous tissue disorders
Night sweats
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/10 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
4.8%
1/21 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Skin and subcutaneous tissue disorders
Petechiae
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/10 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
4.8%
1/21 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Skin and subcutaneous tissue disorders
Rash macular
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/10 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
4.8%
1/21 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Skin and subcutaneous tissue disorders
Urticaria
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/10 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
4.8%
1/21 • Number of events 2 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Respiratory, thoracic and mediastinal disorders
Pruritus
33.3%
1/3 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/10 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/21 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Vascular disorders
Hot flashes
33.3%
1/3 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/10 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/21 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
Vascular disorders
Lymphedema
0.00%
0/3 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/11 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/10 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
4.8%
1/21 • Number of events 1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.
0.00%
0/1 • SAEs and Other Adverse Events: Adverse events were recorded from time of first dose of Vigil and/or atezolizumab up to 30 days following the last dose of study treatment or until another therapy was initiated (up to 12 months). All-cause Mortality: from randomization and up to 37 months following disease progression.
All treated participants.

Additional Information

Clinical and Regulatory Operations

Gradalis, Inc

Phone: 214-442-8100

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place