Trial Outcomes & Findings for My Pathway: A Study Evaluating Herceptin/Perjeta, Tarceva, Zelboraf/Cotellic, Erivedge, Alecensa, and Tecentriq Treatment Targeted Against Certain Molecular Alterations in Participants With Advanced Solid Tumors (NCT NCT02091141)
NCT ID: NCT02091141
Last Updated: 2024-07-23
Results Overview
The Objective Response Rate (ORR) is defined as the percentage of patients whose best response on or before the first occurrence of disease progression is a complete response (CR) or partial response (PR). Tumor responses were assessed by investigators using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 for all arms.
COMPLETED
PHASE2
673 participants
From the date of first study treatment until disease progression or death from any cause, whichever occurs first (72.1 months)
2024-07-23
Participant Flow
Participant milestones
| Measure |
Trastuzumab Plus Pertuzumab
Participants will receive trastuzumab 8 milligrams per kilogram (mg/kg) intravenous (IV) infusion as loading dose, followed by 6 mg/kg IV infusion every 3 weeks; and pertuzumab 840 mg IV infusion as loading dose, followed by 420 mg IV infusion every 3 weeks.
|
Atezolizumab
Participants will receive atezolizumab 1200 mg IV infusion every 3 weeks.
|
Vemurafenib
Participants will receive vemurafenib 960 mg orally twice daily (BID) in each 28-day cycle.
|
Vemurafenib Plus Cobimetinib
Participants will receive vemurafenib 960 mg orally twice daily (BID) in each 28-day cycle; and cobimetinib 60 mg orally once daily for 21 days on and 7 days off in each 28-day cycle.
|
Vismodegib
Participants will receive vismodegib 150 mg orally once daily in each 28-day cycle.
|
Alectinib
Participants will receive alectinib 600 mg orally BID in each 28-day cycle.
|
Erlotinib
Participants will receive erlotinib 150 mg orally once daily in each 28-day cycle.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
357
|
175
|
55
|
15
|
37
|
21
|
13
|
|
Overall Study
COMPLETED
|
28
|
24
|
3
|
0
|
3
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
329
|
151
|
52
|
15
|
34
|
21
|
13
|
Reasons for withdrawal
| Measure |
Trastuzumab Plus Pertuzumab
Participants will receive trastuzumab 8 milligrams per kilogram (mg/kg) intravenous (IV) infusion as loading dose, followed by 6 mg/kg IV infusion every 3 weeks; and pertuzumab 840 mg IV infusion as loading dose, followed by 420 mg IV infusion every 3 weeks.
|
Atezolizumab
Participants will receive atezolizumab 1200 mg IV infusion every 3 weeks.
|
Vemurafenib
Participants will receive vemurafenib 960 mg orally twice daily (BID) in each 28-day cycle.
|
Vemurafenib Plus Cobimetinib
Participants will receive vemurafenib 960 mg orally twice daily (BID) in each 28-day cycle; and cobimetinib 60 mg orally once daily for 21 days on and 7 days off in each 28-day cycle.
|
Vismodegib
Participants will receive vismodegib 150 mg orally once daily in each 28-day cycle.
|
Alectinib
Participants will receive alectinib 600 mg orally BID in each 28-day cycle.
|
Erlotinib
Participants will receive erlotinib 150 mg orally once daily in each 28-day cycle.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Death
|
280
|
118
|
46
|
13
|
31
|
16
|
12
|
|
Overall Study
Withdrawal by Subject
|
21
|
13
|
3
|
2
|
2
|
3
|
0
|
|
Overall Study
Lost to Follow-up
|
21
|
5
|
1
|
0
|
1
|
2
|
0
|
|
Overall Study
Reason Not Specified
|
6
|
5
|
2
|
0
|
0
|
0
|
1
|
|
Overall Study
Study Ended by Sponsor
|
1
|
9
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrew informed consent before receiving study drug
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
My Pathway: A Study Evaluating Herceptin/Perjeta, Tarceva, Zelboraf/Cotellic, Erivedge, Alecensa, and Tecentriq Treatment Targeted Against Certain Molecular Alterations in Participants With Advanced Solid Tumors
Baseline characteristics by cohort
| Measure |
Trastuzumab Plus Pertuzumab
n=357 Participants
Participants will receive trastuzumab 8 milligrams per kilogram (mg/kg) intravenous (IV) infusion as loading dose, followed by 6 mg/kg IV infusion every 3 weeks; and pertuzumab 840 mg IV infusion as loading dose, followed by 420 mg IV infusion every 3 weeks.
|
Atezolizumab
n=174 Participants
Participants will receive atezolizumab 1200 mg IV infusion every 3 weeks.
|
Vemurafenib
n=55 Participants
Participants will receive vemurafenib 960 mg orally twice daily (BID) in each 28-day cycle.
|
Vemurafenib Plus Cobimetinib
n=15 Participants
Participants will receive vemurafenib 960 mg orally twice daily (BID) in each 28-day cycle; and cobimetinib 60 mg orally once daily for 21 days on and 7 days off in each 28-day cycle.
|
Vismodegib
n=37 Participants
Participants will receive vismodegib 150 mg orally once daily in each 28-day cycle.
|
Alectinib
n=21 Participants
Participants will receive alectinib 600 mg orally BID in each 28-day cycle.
|
Erlotinib
n=13 Participants
Participants will receive erlotinib 150 mg orally once daily in each 28-day cycle.
|
Total
n=672 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
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
201 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
11 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
348 Participants
n=6 Participants
|
|
Age, Categorical
>=65 years
|
156 Participants
n=5 Participants
|
97 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
7 Participants
n=115 Participants
|
324 Participants
n=6 Participants
|
|
Age, Customized
|
61.0 Years
STANDARD_DEVIATION 12.06 • n=5 Participants
|
65.1 Years
STANDARD_DEVIATION 12.33 • n=7 Participants
|
61.3 Years
STANDARD_DEVIATION 11.15 • n=5 Participants
|
63.2 Years
STANDARD_DEVIATION 8.69 • n=4 Participants
|
63.5 Years
STANDARD_DEVIATION 11.41 • n=21 Participants
|
63.5 Years
STANDARD_DEVIATION 12.17 • n=10 Participants
|
64.5 Years
STANDARD_DEVIATION 13.41 • n=115 Participants
|
62.4 Years
STANDARD_DEVIATION 12.08 • n=6 Participants
|
|
Sex: Female, Male
Female
|
179 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
12 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
346 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
178 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
8 Participants
n=115 Participants
|
326 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
19 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
40 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
320 Participants
n=5 Participants
|
152 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
36 Participants
n=21 Participants
|
20 Participants
n=10 Participants
|
12 Participants
n=115 Participants
|
600 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
18 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
32 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
7 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
21 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
37 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
28 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
60 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
288 Participants
n=5 Participants
|
131 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
18 Participants
n=10 Participants
|
10 Participants
n=115 Participants
|
537 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
16 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
29 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: From the date of first study treatment until disease progression or death from any cause, whichever occurs first (72.1 months)Population: The efficacy evaluable population included all participants who received at least one dose of each drug for their assigned treatment regimen. The population includes the treated participants who have baseline tumor measurement and either have a post-baseline tumor measurement or have discontinued treatment for any reason.
The Objective Response Rate (ORR) is defined as the percentage of patients whose best response on or before the first occurrence of disease progression is a complete response (CR) or partial response (PR). Tumor responses were assessed by investigators using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 for all arms.
Outcome measures
| Measure |
Trastuzumab Plus Pertuzumab
n=357 Participants
Participants will receive trastuzumab 8 milligrams per kilogram (mg/kg) intravenous (IV) infusion as loading dose, followed by 6 mg/kg IV infusion every 3 weeks; and pertuzumab 840 mg IV infusion as loading dose, followed by 420 mg IV infusion every 3 weeks.
|
Atezolizumab
n=174 Participants
Participants will receive atezolizumab 1200 mg IV infusion every 3 weeks.
|
Vemurafenib
n=55 Participants
Participants will receive vemurafenib 960 mg orally twice daily (BID) in each 28-day cycle.
|
Vemurafenib Plus Cobimetinib
n=15 Participants
Participants will receive vemurafenib 960 mg orally twice daily (BID) in each 28-day cycle; and cobimetinib 60 mg orally once daily for 21 days on and 7 days off in each 28-day cycle.
|
Vismodegib
n=37 Participants
Participants will receive vismodegib 150 mg orally once daily in each 28-day cycle.
|
Alectinib
n=21 Participants
Participants will receive alectinib 600 mg orally BID in each 28-day cycle.
|
Erlotinib
n=13 Participants
Participants will receive erlotinib 150 mg orally once daily in each 28-day cycle.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants in All Tumor-Pathway Cohorts With Overall Response, as Assessed by the Investigator
|
21.0 Percentage of Participants
Interval 16.9 to 25.6
|
19.5 Percentage of Participants
Interval 13.9 to 26.2
|
25.5 Percentage of Participants
Interval 14.7 to 39.0
|
33.3 Percentage of Participants
Interval 11.8 to 61.6
|
10.8 Percentage of Participants
Interval 3.0 to 25.4
|
14.3 Percentage of Participants
Interval 3.0 to 36.3
|
7.7 Percentage of Participants
Interval 0.2 to 36.0
|
PRIMARY outcome
Timeframe: From the date of first study treatment until disease progression or death from any cause, whichever occurs first (68.9 months)Population: The efficacy evaluable population included all atezolizumab-treated participants with tumor mutation burden ≥16 Mutations/Mb and whose tumor responses were assessed by Independent Review Committee (IRC).
The Objective Response Rate (ORR) is defined as the proportion of patients whose best response on or before the first occurrence of disease progression is a complete response (CR) or partial response (PR). Tumor responses were assessed by Independent Review Committee (IRC) using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Outcome measures
| Measure |
Trastuzumab Plus Pertuzumab
n=44 Participants
Participants will receive trastuzumab 8 milligrams per kilogram (mg/kg) intravenous (IV) infusion as loading dose, followed by 6 mg/kg IV infusion every 3 weeks; and pertuzumab 840 mg IV infusion as loading dose, followed by 420 mg IV infusion every 3 weeks.
|
Atezolizumab
Participants will receive atezolizumab 1200 mg IV infusion every 3 weeks.
|
Vemurafenib
Participants will receive vemurafenib 960 mg orally twice daily (BID) in each 28-day cycle.
|
Vemurafenib Plus Cobimetinib
Participants will receive vemurafenib 960 mg orally twice daily (BID) in each 28-day cycle; and cobimetinib 60 mg orally once daily for 21 days on and 7 days off in each 28-day cycle.
|
Vismodegib
Participants will receive vismodegib 150 mg orally once daily in each 28-day cycle.
|
Alectinib
Participants will receive alectinib 600 mg orally BID in each 28-day cycle.
|
Erlotinib
Participants will receive erlotinib 150 mg orally once daily in each 28-day cycle.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Atezolizumab-Treated Participants With Tissue Tumor Mutational Burden (tTMB) ≥16 Mutations/Mb With Overall Response, as Assessed by the Independent Review Committee (IRC)
|
29.5 Percentage of Participants
Interval 16.8 to 45.2
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From the date of first study treatment until disease progression or death from any cause, whichever occurs first (72.1 months)Population: The efficacy evaluable population included all participants who received at least one dose of each drug for their assigned treatment regimen. The population includes the treated participants who have baseline tumor measurement and either have a post-baseline tumor measurement or have discontinued treatment for any reason.
Disease Control Rate (DCR) is defined as the proportion of patients whose best response is CR, PR or stable disease maintained more than 4 months (SD\>4 months). Tumor responses were assessed by investigators using RECIST version 1.1 for all arms.
Outcome measures
| Measure |
Trastuzumab Plus Pertuzumab
n=357 Participants
Participants will receive trastuzumab 8 milligrams per kilogram (mg/kg) intravenous (IV) infusion as loading dose, followed by 6 mg/kg IV infusion every 3 weeks; and pertuzumab 840 mg IV infusion as loading dose, followed by 420 mg IV infusion every 3 weeks.
|
Atezolizumab
n=174 Participants
Participants will receive atezolizumab 1200 mg IV infusion every 3 weeks.
|
Vemurafenib
n=55 Participants
Participants will receive vemurafenib 960 mg orally twice daily (BID) in each 28-day cycle.
|
Vemurafenib Plus Cobimetinib
n=15 Participants
Participants will receive vemurafenib 960 mg orally twice daily (BID) in each 28-day cycle; and cobimetinib 60 mg orally once daily for 21 days on and 7 days off in each 28-day cycle.
|
Vismodegib
n=37 Participants
Participants will receive vismodegib 150 mg orally once daily in each 28-day cycle.
|
Alectinib
n=21 Participants
Participants will receive alectinib 600 mg orally BID in each 28-day cycle.
|
Erlotinib
n=13 Participants
Participants will receive erlotinib 150 mg orally once daily in each 28-day cycle.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Disease Control
|
41.5 Percentage of Participants
Interval 36.3 to 46.8
|
39.1 Percentage of Participants
Interval 31.8 to 46.8
|
34.5 Percentage of Participants
Interval 22.2 to 48.6
|
66.7 Percentage of Participants
Interval 38.4 to 88.2
|
16.2 Percentage of Participants
Interval 6.2 to 32.0
|
42.9 Percentage of Participants
Interval 21.8 to 66.0
|
23.1 Percentage of Participants
Interval 5.0 to 53.8
|
SECONDARY outcome
Timeframe: From the date of first study treatment until disease progression as assessed by the investigator, or death from any cause, whichever occurs first (72.1 months)Population: The efficacy evaluable population included all patients who received at least one dose of each drug for their assigned treatment regimen. The population includes the treated participants who have baseline tumor measurement and either have a post-baseline tumor measurement or have discontinued treatment for any reason.
PFS is defined as the time from the start of study treatment to the first occurrence of disease progression, or death, whichever occurs first. Tumor responses were assessed by investigators using RECIST version 1.1 for all arms.
Outcome measures
| Measure |
Trastuzumab Plus Pertuzumab
n=357 Participants
Participants will receive trastuzumab 8 milligrams per kilogram (mg/kg) intravenous (IV) infusion as loading dose, followed by 6 mg/kg IV infusion every 3 weeks; and pertuzumab 840 mg IV infusion as loading dose, followed by 420 mg IV infusion every 3 weeks.
|
Atezolizumab
n=174 Participants
Participants will receive atezolizumab 1200 mg IV infusion every 3 weeks.
|
Vemurafenib
n=55 Participants
Participants will receive vemurafenib 960 mg orally twice daily (BID) in each 28-day cycle.
|
Vemurafenib Plus Cobimetinib
n=15 Participants
Participants will receive vemurafenib 960 mg orally twice daily (BID) in each 28-day cycle; and cobimetinib 60 mg orally once daily for 21 days on and 7 days off in each 28-day cycle.
|
Vismodegib
n=37 Participants
Participants will receive vismodegib 150 mg orally once daily in each 28-day cycle.
|
Alectinib
n=21 Participants
Participants will receive alectinib 600 mg orally BID in each 28-day cycle.
|
Erlotinib
n=13 Participants
Participants will receive erlotinib 150 mg orally once daily in each 28-day cycle.
|
|---|---|---|---|---|---|---|---|
|
Progression-Free Survival (PFS)
|
2.8 Months
Interval 2.7 to 3.4
|
2.7 Months
Interval 1.6 to 3.0
|
3.1 Months
Interval 1.8 to 5.5
|
8.2 Months
Interval 3.9 to 19.5
|
1.8 Months
Interval 1.6 to 1.8
|
3.2 Months
Interval 1.7 to 6.6
|
1.8 Months
Interval 1.0 to 8.8
|
SECONDARY outcome
Timeframe: 87.5 monthsPopulation: The efficacy evaluable population included all participants who received at least one dose of each drug for their assigned treatment regimen. The population includes the treated participants who have baseline tumor measurement and either have a post-baseline tumor measurement or have discontinued treatment for any reason.
Overall Survival (OS, months) is defined as the time from the date of the first study treatment (Day 1) to the date of death from any cause.
Outcome measures
| Measure |
Trastuzumab Plus Pertuzumab
n=357 Participants
Participants will receive trastuzumab 8 milligrams per kilogram (mg/kg) intravenous (IV) infusion as loading dose, followed by 6 mg/kg IV infusion every 3 weeks; and pertuzumab 840 mg IV infusion as loading dose, followed by 420 mg IV infusion every 3 weeks.
|
Atezolizumab
n=174 Participants
Participants will receive atezolizumab 1200 mg IV infusion every 3 weeks.
|
Vemurafenib
n=55 Participants
Participants will receive vemurafenib 960 mg orally twice daily (BID) in each 28-day cycle.
|
Vemurafenib Plus Cobimetinib
n=15 Participants
Participants will receive vemurafenib 960 mg orally twice daily (BID) in each 28-day cycle; and cobimetinib 60 mg orally once daily for 21 days on and 7 days off in each 28-day cycle.
|
Vismodegib
n=37 Participants
Participants will receive vismodegib 150 mg orally once daily in each 28-day cycle.
|
Alectinib
n=21 Participants
Participants will receive alectinib 600 mg orally BID in each 28-day cycle.
|
Erlotinib
n=13 Participants
Participants will receive erlotinib 150 mg orally once daily in each 28-day cycle.
|
|---|---|---|---|---|---|---|---|
|
Overall Survival (OS)
|
10.1 Months
Interval 8.7 to 11.7
|
13.5 Months
Interval 11.2 to 17.4
|
10.6 Months
Interval 5.2 to 13.5
|
15.6 Months
Interval 6.8 to 27.9
|
9.8 Months
Interval 4.0 to 13.4
|
14.1 Months
Interval 8.7 to 25.6
|
7.7 Months
Interval 2.2 to 15.0
|
SECONDARY outcome
Timeframe: From the date of first documented response (complete response [CR] or partial response [PR]) to the time of disease progression or death from any cause, whichever occurs first (70.8 months)Population: Efficacy evaluable population who have achieved a complete or partial response.
Duration of Response (DoR) is defined as the time from the date of first documented response (CR or PR) to date of first occurrence of disease progression as determined by the investigator, or death from any cause, whichever occurs first.
Outcome measures
| Measure |
Trastuzumab Plus Pertuzumab
n=75 Participants
Participants will receive trastuzumab 8 milligrams per kilogram (mg/kg) intravenous (IV) infusion as loading dose, followed by 6 mg/kg IV infusion every 3 weeks; and pertuzumab 840 mg IV infusion as loading dose, followed by 420 mg IV infusion every 3 weeks.
|
Atezolizumab
n=34 Participants
Participants will receive atezolizumab 1200 mg IV infusion every 3 weeks.
|
Vemurafenib
n=14 Participants
Participants will receive vemurafenib 960 mg orally twice daily (BID) in each 28-day cycle.
|
Vemurafenib Plus Cobimetinib
n=5 Participants
Participants will receive vemurafenib 960 mg orally twice daily (BID) in each 28-day cycle; and cobimetinib 60 mg orally once daily for 21 days on and 7 days off in each 28-day cycle.
|
Vismodegib
n=4 Participants
Participants will receive vismodegib 150 mg orally once daily in each 28-day cycle.
|
Alectinib
n=3 Participants
Participants will receive alectinib 600 mg orally BID in each 28-day cycle.
|
Erlotinib
n=1 Participants
Participants will receive erlotinib 150 mg orally once daily in each 28-day cycle.
|
|---|---|---|---|---|---|---|---|
|
Duration of Response (DoR)
|
7.3 Months
Interval 5.8 to 9.3
|
32.1 Months
Interval 6.9 to
The upper 95% confidence limit of median is not estimable due to insufficient number of events (disease progression/death) below 50th percentile of Kaplan-Meier curve
|
6.0 Months
Interval 3.7 to 11.1
|
17.2 Months
Interval 7.4 to
The upper 95% confidence limit of median is not estimable due to insufficient number of events (disease progression/death) below 50th percentile of Kaplan-Meier curve
|
14.1 Months
Interval 6.5 to
The upper 95% confidence limit of median is not estimable due to insufficient number of events (disease progression/death) below 50th percentile of Kaplan-Meier curve
|
6.6 Months
Interval 6.0 to
The upper 95% confidence limit of median is not estimable due to insufficient number of events (disease progression/death) below 50th percentile of Kaplan-Meier curve
|
8.3 Months
There was only one participant in this arm, therefore there are too few participants to calculate confidence intervals.
|
SECONDARY outcome
Timeframe: From first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years)Population: The safety (SAF) population is defined as enrolled patients who receive at least one dose of study medication.
Incidence, nature, and severity of Adverse Events (AE), per the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 (NCI CTCAE v4.03) for participants enrolled prior to Version 6 of the protocol. The NCI CTCAE (v5.0) grading scale was used for assessing AE severity for participants enrolled under Version 6 of the protocol and subsequent versions.
Outcome measures
| Measure |
Trastuzumab Plus Pertuzumab
n=357 Participants
Participants will receive trastuzumab 8 milligrams per kilogram (mg/kg) intravenous (IV) infusion as loading dose, followed by 6 mg/kg IV infusion every 3 weeks; and pertuzumab 840 mg IV infusion as loading dose, followed by 420 mg IV infusion every 3 weeks.
|
Atezolizumab
n=174 Participants
Participants will receive atezolizumab 1200 mg IV infusion every 3 weeks.
|
Vemurafenib
n=55 Participants
Participants will receive vemurafenib 960 mg orally twice daily (BID) in each 28-day cycle.
|
Vemurafenib Plus Cobimetinib
n=15 Participants
Participants will receive vemurafenib 960 mg orally twice daily (BID) in each 28-day cycle; and cobimetinib 60 mg orally once daily for 21 days on and 7 days off in each 28-day cycle.
|
Vismodegib
n=37 Participants
Participants will receive vismodegib 150 mg orally once daily in each 28-day cycle.
|
Alectinib
n=21 Participants
Participants will receive alectinib 600 mg orally BID in each 28-day cycle.
|
Erlotinib
n=13 Participants
Participants will receive erlotinib 150 mg orally once daily in each 28-day cycle.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events
With at least one AE
|
334 Participants
|
162 Participants
|
54 Participants
|
15 Participants
|
35 Participants
|
21 Participants
|
12 Participants
|
|
Number of Participants With Adverse Events
With at least one SAE
|
95 Participants
|
62 Participants
|
21 Participants
|
11 Participants
|
13 Participants
|
7 Participants
|
3 Participants
|
|
Number of Participants With Adverse Events
With at least one Grade 3-5 AE
|
146 Participants
|
97 Participants
|
37 Participants
|
12 Participants
|
21 Participants
|
11 Participants
|
4 Participants
|
|
Number of Participants With Adverse Events
With at least one Related AE
|
261 Participants
|
104 Participants
|
49 Participants
|
13 Participants
|
26 Participants
|
19 Participants
|
9 Participants
|
|
Number of Participants With Adverse Events
With at least one Related SAE
|
17 Participants
|
14 Participants
|
6 Participants
|
5 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
With at least one Grade 3-5 related AE
|
43 Participants
|
25 Participants
|
25 Participants
|
6 Participants
|
8 Participants
|
4 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events
With at least one non-serious AESI
|
5 Participants
|
9 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
With at least one AE leading to study drug withdrawn
|
17 Participants
|
15 Participants
|
10 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events
With at least one AE leading to study drug interruption
|
79 Participants
|
45 Participants
|
27 Participants
|
11 Participants
|
11 Participants
|
6 Participants
|
4 Participants
|
|
Number of Participants With Adverse Events
With at least one AE leading to study drug reduction
|
3 Participants
|
1 Participants
|
28 Participants
|
3 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
With at least one AE leading to death
|
13 Participants
|
5 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
Adverse Events
Trastuzumab Plus Pertuzumab
Atezolizumab
Vemurafenib
Vemurafenib Plus Cobimetinib
Vismodegib
Alectinib
Erlotinib
Serious adverse events
| Measure |
Trastuzumab Plus Pertuzumab
n=357 participants at risk
Participants will receive trastuzumab 8 milligrams per kilogram (mg/kg) intravenous (IV) infusion as loading dose, followed by 6 mg/kg IV infusion every 3 weeks; and pertuzumab 840 mg IV infusion as loading dose, followed by 420 mg IV infusion every 3 weeks.
|
Atezolizumab
n=174 participants at risk
Participants will receive atezolizumab 1200 mg IV infusion every 3 weeks.
|
Vemurafenib
n=55 participants at risk
Participants will receive vemurafenib 960 mg orally twice daily (BID) in each 28-day cycle.
|
Vemurafenib Plus Cobimetinib
n=15 participants at risk
Participants will receive vemurafenib 960 mg orally twice daily (BID) in each 28-day cycle; and cobimetinib 60 mg orally once daily for 21 days on and 7 days off in each 28-day cycle.
|
Vismodegib
n=37 participants at risk
Participants will receive vismodegib 150 mg orally once daily in each 28-day cycle.
|
Alectinib
n=21 participants at risk
Participants will receive alectinib 600 mg orally BID in each 28-day cycle.
|
Erlotinib
n=13 participants at risk
Participants will receive erlotinib 150 mg orally once daily in each 28-day cycle.
|
|---|---|---|---|---|---|---|---|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
1.8%
1/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
6.7%
1/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Vascular disorders
Hypotension
|
0.28%
1/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.57%
1/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.4%
5/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.57%
1/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
1.8%
1/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
4.8%
1/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Blood and lymphatic system disorders
Anaemia of malignant disease
|
0.00%
0/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
6.7%
1/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
1.8%
1/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
1.8%
1/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
0.28%
1/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.57%
1/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
1.8%
1/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Cardiac disorders
Cardiac arrest
|
0.28%
1/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
1.8%
1/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Cardiac disorders
Cardiac failure
|
0.28%
1/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
6.7%
1/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.57%
1/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.28%
1/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Cardiac disorders
Myocardial infarction
|
0.28%
1/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
1.8%
1/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.00%
0/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
6.7%
1/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Cardiac disorders
Tachycardia
|
0.28%
1/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Cardiac disorders
Wolff-Parkinson-White syndrome
|
0.00%
0/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
1.8%
1/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.1%
4/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
1.7%
3/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Gastrointestinal disorders
Ascites
|
0.28%
1/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
2.7%
1/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
4.8%
1/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Gastrointestinal disorders
Colitis
|
0.28%
1/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
1.1%
2/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
1.1%
2/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.28%
1/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
1.1%
2/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
2.7%
1/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
6.7%
1/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.57%
1/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.57%
1/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
6.7%
1/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.28%
1/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.28%
1/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
1.7%
3/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.28%
1/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Gastrointestinal disorders
Ileus
|
0.28%
1/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.28%
1/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
6.7%
1/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
2.7%
1/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Gastrointestinal disorders
Large intestinal haemorrhage
|
0.28%
1/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.28%
1/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.28%
1/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.57%
1/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
3.6%
2/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
4.8%
1/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.56%
2/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.57%
1/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.00%
0/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
1.8%
1/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.28%
1/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.00%
0/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.57%
1/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
3.6%
2/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.7%
6/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
1.7%
3/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
20.0%
3/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
5.4%
2/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
7.7%
1/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Gastrointestinal disorders
Superior mesenteric artery syndrome
|
0.28%
1/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.56%
2/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
3.6%
2/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
4.8%
1/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
General disorders
Asthenia
|
0.28%
1/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
General disorders
Chest pain
|
0.28%
1/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
General disorders
Chills
|
0.28%
1/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
General disorders
Death
|
0.28%
1/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
6.7%
1/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
General disorders
Pyrexia
|
0.28%
1/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
1.1%
2/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
1.8%
1/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
13.3%
2/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
General disorders
Sudden death
|
0.00%
0/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.57%
1/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.57%
1/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.00%
0/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.57%
1/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Hepatobiliary disorders
Biliary obstruction
|
0.00%
0/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.57%
1/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Hepatobiliary disorders
Cholangitis
|
0.28%
1/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
1.8%
1/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.28%
1/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
1.8%
1/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
1.8%
1/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
6.7%
1/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
1.8%
1/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Infections and infestations
Abdominal abscess
|
0.28%
1/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Infections and infestations
Appendicitis
|
0.28%
1/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.57%
1/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
6.7%
1/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Infections and infestations
Bacterial infection
|
0.28%
1/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
4.8%
1/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Infections and infestations
Covid-19 pneumonia
|
0.00%
0/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.57%
1/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Infections and infestations
Cellulitis
|
0.28%
1/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
1.8%
1/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Infections and infestations
Cholangitis infective
|
0.28%
1/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Infections and infestations
Clostridium colitis
|
0.28%
1/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
6.7%
1/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Infections and infestations
Device related infection
|
0.84%
3/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Infections and infestations
Diverticulitis
|
0.28%
1/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Infections and infestations
Enterocolitis infectious
|
0.28%
1/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Infections and infestations
Gastrointestinal viral
|
0.28%
1/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
1.8%
1/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Infections and infestations
Infection
|
0.28%
1/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Infections and infestations
Infectious pleural effusion
|
0.00%
0/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
6.7%
1/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Infections and infestations
Influenza
|
0.00%
0/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
1.8%
1/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Infections and infestations
Kidney infection
|
0.28%
1/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Infections and infestations
Liver abscess
|
0.28%
1/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Infections and infestations
Ophthalmic herpes zoster
|
0.28%
1/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Infections and infestations
Pelvic infection
|
0.28%
1/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Infections and infestations
Perirectal abscess
|
0.28%
1/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
6.7%
1/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Infections and infestations
Pneumonia
|
1.1%
4/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
2.9%
5/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
3.6%
2/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
5.4%
2/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
7.7%
1/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Infections and infestations
Pneumonia aspiration
|
0.28%
1/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
1.1%
2/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Infections and infestations
Sepsis
|
1.4%
5/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
2.3%
4/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
1.8%
1/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
13.3%
2/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
2.7%
1/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Infections and infestations
Sialoadenitis
|
0.00%
0/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
2.7%
1/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Infections and infestations
Skin infection
|
0.00%
0/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
1.8%
1/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Infections and infestations
Soft tissue infection
|
0.28%
1/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Infections and infestations
Urinary tract infection
|
1.4%
5/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
1.1%
2/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
3.6%
2/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
6.7%
1/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.28%
1/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Infections and infestations
Urinary tract infection pseudomonal
|
0.00%
0/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.57%
1/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Infections and infestations
Urosepsis
|
0.56%
2/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Infections and infestations
Vascular device infection
|
0.00%
0/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
6.7%
1/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Infections and infestations
Wound infection
|
0.00%
0/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.57%
1/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
0.56%
2/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.57%
1/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
7.7%
1/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.28%
1/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
1.4%
5/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.28%
1/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.57%
1/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.28%
1/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.57%
1/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.57%
1/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
4.8%
1/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
0.28%
1/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.57%
1/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
4.8%
1/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Investigations
Blood bilirubin increased
|
0.28%
1/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Investigations
Ejection fraction decreased
|
0.28%
1/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
13.3%
2/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Investigations
International Normalised Ratio increased
|
0.28%
1/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
5.4%
2/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Investigations
Liver function test increased
|
0.00%
0/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.57%
1/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.84%
3/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
1.1%
2/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
2.7%
1/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.28%
1/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.57%
1/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
3.6%
2/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.57%
1/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
2.7%
1/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
2.7%
1/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
1.8%
1/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.28%
1/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.57%
1/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.57%
1/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.84%
3/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.28%
1/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.28%
1/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.57%
1/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.57%
1/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.57%
1/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.57%
1/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.57%
1/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.57%
1/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.57%
1/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Nervous system disorders
Central nervous system lesion
|
0.00%
0/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
1.8%
1/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Nervous system disorders
Cerebrospinal fluid leakage
|
0.28%
1/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.57%
1/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
4.8%
1/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Nervous system disorders
Dementia
|
0.00%
0/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.57%
1/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Nervous system disorders
Embolic cerebral infarction
|
0.28%
1/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Nervous system disorders
Embolic stroke
|
0.00%
0/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
6.7%
1/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.28%
1/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Nervous system disorders
Seizure
|
0.84%
3/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
1.1%
2/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Nervous system disorders
Syncope
|
0.00%
0/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.57%
1/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Psychiatric disorders
Confusional state
|
0.28%
1/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.57%
1/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
7.7%
1/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.57%
1/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.57%
1/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.1%
4/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
2.3%
4/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
1.8%
1/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
2.7%
1/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Renal and urinary disorders
Haematuria
|
0.28%
1/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.57%
1/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Renal and urinary disorders
Renal failure
|
0.28%
1/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.57%
1/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
4.8%
1/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
1.8%
1/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.28%
1/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
2.7%
1/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
6.7%
1/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Autoimmune lung disease
|
0.00%
0/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.57%
1/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.56%
2/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
2.7%
1/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.1%
4/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
1.1%
2/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
3.6%
2/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
6.7%
1/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
4.8%
1/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.56%
2/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
1.1%
2/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.84%
3/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
1.7%
3/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
1.8%
1/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
2.7%
1/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.56%
2/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.57%
1/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
4.8%
1/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
1.1%
2/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.28%
1/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
1.8%
1/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.56%
2/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
6.7%
1/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
6.7%
1/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
6.7%
1/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Vascular disorders
Embolism
|
0.28%
1/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Vascular disorders
Haematoma
|
0.00%
0/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.57%
1/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
Other adverse events
| Measure |
Trastuzumab Plus Pertuzumab
n=357 participants at risk
Participants will receive trastuzumab 8 milligrams per kilogram (mg/kg) intravenous (IV) infusion as loading dose, followed by 6 mg/kg IV infusion every 3 weeks; and pertuzumab 840 mg IV infusion as loading dose, followed by 420 mg IV infusion every 3 weeks.
|
Atezolizumab
n=174 participants at risk
Participants will receive atezolizumab 1200 mg IV infusion every 3 weeks.
|
Vemurafenib
n=55 participants at risk
Participants will receive vemurafenib 960 mg orally twice daily (BID) in each 28-day cycle.
|
Vemurafenib Plus Cobimetinib
n=15 participants at risk
Participants will receive vemurafenib 960 mg orally twice daily (BID) in each 28-day cycle; and cobimetinib 60 mg orally once daily for 21 days on and 7 days off in each 28-day cycle.
|
Vismodegib
n=37 participants at risk
Participants will receive vismodegib 150 mg orally once daily in each 28-day cycle.
|
Alectinib
n=21 participants at risk
Participants will receive alectinib 600 mg orally BID in each 28-day cycle.
|
Erlotinib
n=13 participants at risk
Participants will receive erlotinib 150 mg orally once daily in each 28-day cycle.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
17.6%
63/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
15.5%
27/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
18.2%
10/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
13.3%
2/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
13.5%
5/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
19.0%
4/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
23.1%
3/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
5.0%
18/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
4.6%
8/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
1.8%
1/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
6.7%
1/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
5.4%
2/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
14.3%
3/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
7.7%
1/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
12.0%
43/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
14.4%
25/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
10.9%
6/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
33.3%
5/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
2.7%
1/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
19.0%
4/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
7.7%
1/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Gastrointestinal disorders
Constipation
|
10.4%
37/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
13.2%
23/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
16.4%
9/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
20.0%
3/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
16.2%
6/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
33.3%
7/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
36.1%
129/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
20.1%
35/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
23.6%
13/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
46.7%
7/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
24.3%
9/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
14.3%
3/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
46.2%
6/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
22.4%
80/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
23.0%
40/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
38.2%
21/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
53.3%
8/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
21.6%
8/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
28.6%
6/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
30.8%
4/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
13.2%
47/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
14.9%
26/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
23.6%
13/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
40.0%
6/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
5.4%
2/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
4.8%
1/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
7.7%
1/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
General disorders
Chills
|
12.9%
46/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
3.4%
6/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
3.6%
2/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
13.3%
2/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
4.8%
1/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
7.7%
1/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
General disorders
Fatigue
|
29.4%
105/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
26.4%
46/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
52.7%
29/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
46.7%
7/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
37.8%
14/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
33.3%
7/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
38.5%
5/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
General disorders
Oedema peripheral
|
7.3%
26/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
8.0%
14/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
9.1%
5/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
40.0%
6/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
16.2%
6/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
33.3%
7/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
General disorders
Pyrexia
|
10.1%
36/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
9.2%
16/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
7.3%
4/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
33.3%
5/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
5.4%
2/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
4.8%
1/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
30.8%
4/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Infections and infestations
Urinary tract infection
|
7.3%
26/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
9.2%
16/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
1.8%
1/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
20.0%
3/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
2.7%
1/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
14.3%
51/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
5.7%
10/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
7.3%
26/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
5.7%
10/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
7.3%
4/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
6.7%
1/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
2.7%
1/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
4.8%
1/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
7.7%
1/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
7.6%
27/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
8.0%
14/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
14.5%
8/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
5.4%
2/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
9.5%
2/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
7.7%
1/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Investigations
Blood alkaline phosphatase increased
|
10.4%
37/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
7.5%
13/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
14.5%
8/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
20.0%
3/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
13.5%
5/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
14.3%
3/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Investigations
Blood bilirubin increased
|
5.6%
20/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
4.6%
8/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
14.5%
8/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
6.7%
1/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Investigations
Blood creatinine increased
|
5.0%
18/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
8.6%
15/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
7.3%
4/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
6.7%
1/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
2.7%
1/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
14.3%
3/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Investigations
Weight decreased
|
8.1%
29/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
10.3%
18/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
14.5%
8/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
20.0%
3/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
13.5%
5/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
4.8%
1/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
7.7%
1/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
14.6%
52/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
12.6%
22/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
18.2%
10/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
33.3%
5/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
13.5%
5/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
14.3%
3/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
46.2%
6/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.4%
12/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
12.1%
21/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
10.9%
6/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
26.7%
4/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
2.7%
1/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
7.7%
1/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
4.2%
15/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
7.5%
13/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
5.5%
3/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
6.7%
1/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
8.1%
3/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
9.5%
2/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
7.7%
1/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
8.1%
29/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
2.3%
4/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
9.1%
5/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
13.3%
2/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
8.1%
3/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
9.5%
2/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
5.9%
21/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
13.8%
24/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
7.3%
4/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
4.8%
1/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
7.7%
1/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.3%
44/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
12.6%
22/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
32.7%
18/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
26.7%
4/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
5.4%
2/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
9.5%
2/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.0%
32/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
12.6%
22/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
12.7%
7/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
6.7%
1/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
5.4%
2/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
28.6%
6/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.4%
23/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.57%
1/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
6.7%
1/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
18.9%
7/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
4.8%
1/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
7.7%
1/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.5%
16/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
9.2%
16/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
10.9%
6/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
13.3%
2/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
13.5%
5/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
19.0%
4/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
15.4%
2/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Nervous system disorders
Dizziness
|
4.2%
15/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
9.2%
16/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
3.6%
2/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
2.7%
1/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
9.5%
2/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Nervous system disorders
Headache
|
7.6%
27/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
12.1%
21/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
14.5%
8/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
8.1%
3/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
9.5%
2/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
7.7%
1/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Psychiatric disorders
Insomnia
|
7.6%
27/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
3.4%
6/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
7.3%
4/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
6.7%
1/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
5.4%
2/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
4.8%
1/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
7.7%
1/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.3%
44/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
16.7%
29/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
10.9%
6/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
13.3%
2/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
2.7%
1/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
14.3%
3/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
15.4%
2/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.5%
41/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
11.5%
20/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
10.9%
6/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
13.3%
2/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
10.8%
4/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
23.8%
5/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
15.4%
2/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.0%
25/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
2.9%
5/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
12.7%
7/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
13.3%
2/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
5.4%
2/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
9.5%
2/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.8%
35/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
11.5%
20/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
7.3%
4/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
13.3%
2/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
4.8%
1/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.6%
38/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
2.9%
5/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
20.0%
11/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
26.7%
4/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
5.4%
2/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
15.4%
2/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
3.1%
11/357 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
6.3%
11/174 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
23.6%
13/55 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
13.3%
2/15 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/37 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
4.8%
1/21 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
0.00%
0/13 • In the AE section, AE timeframe was from first study treatment administration to 30 days (45 days for vismodegib, 90 days for atezolizumab) after the last dose (up to approximately 6.3 years).
The incidence, nature, and severity of Adverse Events (AE) and Serious Adverse Events (SAE) were reported, with severity determined according to NCI CTCAE v5.0 of the safety population, defined as all randomized participants who received ≥1 dose of study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER