Trial Outcomes & Findings for Atezolizumab and CYT107 in Treating Participants With Locally Advanced, Inoperable, or Metastatic Urothelial Carcinoma (NCT NCT03513952)

NCT ID: NCT03513952

Last Updated: 2024-07-26

Results Overview

ORR is defined as the proportion of patients who have achieved Complete Response (CR) - disappearance of all target lesions or Partial Response (PR) - \>=30% decrease in the sum of the longest diameter of target lesions according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1; Overall Response (OR) = CR + PR.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

47 participants

Primary outcome timeframe

Up to 2 years

Results posted on

2024-07-26

Participant Flow

Safety Run-In Phase: If the treatment combination demonstrates an acceptable safety profile (one or fewer patient experiences a protocol-defined Dose Limiting-Toxicity), randomized enrollment will begin.

Participant milestones

Participant milestones
Measure
Group 1 (CYT107, Atezolizumab)
Patients receive CYT107 on days 1, 8, 15, and 22, and atezolizumab on day 8 of cycle 1. Following cycle 1, patients receive atezolizumab on day 1. Cycles with atezolizumab repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Atezolizumab: Given IV Glycosylated Recombinant Human Interleukin-7: Given IM
Group 2 (Atezolizumab)
Patients receive atezolizumab on Day 1 of each cycle. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Atezolizumab: Given IV
Safety Run in Phase
Patients were not randomized; they were assigned to the experimental arm treatment (atezolizumab + CYT107). Patients receive CYT107 on days 1, 8, 15, and 22, and atezolizumab on day 8 of cycle 1. Following cycle 1, patients receive atezolizumab on day 1. Cycles with atezolizumab repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Atezolizumab: Given IV Glycosylated Recombinant Human Interleukin-7: Given IM
Overall Study
STARTED
19
21
7
Overall Study
COMPLETED
3
2
0
Overall Study
NOT COMPLETED
16
19
7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Atezolizumab and CYT107 in Treating Participants With Locally Advanced, Inoperable, or Metastatic Urothelial Carcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Group 1 (CYT107, Atezolizumab)
n=19 Participants
Patients receive CYT107 on days 1, 8, 15, and 22, and atezolizumab on day 8 of cycle 1. Following cycle 1, patients receive atezolizumab on day 1. Cycles with atezolizumab repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Atezolizumab: Given IV Glycosylated Recombinant Human Interleukin-7: Given IM
Group 2 (Atezolizumab)
n=21 Participants
Patients receive atezolizumab on day 1 of each cycle. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Atezolizumab: Given IV
Safety Run in Phase
n=7 Participants
Patients were not randomized; they were assigned to the experimental arm treatment (atezolizumab + CYT107). Patients receive CYT107 on days 1, 8, 15, and 22, and atezolizumab on day 8 of cycle 1. Following cycle 1, patients receive atezolizumab on day 1. Cycles with atezolizumab repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Atezolizumab: Given IV Glycosylated Recombinant Human Interleukin-7: Given IM
Total
n=47 Participants
Total of all reporting groups
Age, Continuous
65.7 years
STANDARD_DEVIATION 9.2 • n=5 Participants
66.3 years
STANDARD_DEVIATION 8.5 • n=7 Participants
59.7 years
STANDARD_DEVIATION 11 • n=5 Participants
65.1 years
STANDARD_DEVIATION 9.3 • n=4 Participants
Sex: Female, Male
Female
3 Participants
n=5 Participants
5 Participants
n=7 Participants
1 Participants
n=5 Participants
9 Participants
n=4 Participants
Sex: Female, Male
Male
16 Participants
n=5 Participants
16 Participants
n=7 Participants
6 Participants
n=5 Participants
38 Participants
n=4 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=5 Participants
2 Participants
n=7 Participants
0 Participants
n=5 Participants
2 Participants
n=4 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
19 Participants
n=5 Participants
19 Participants
n=7 Participants
6 Participants
n=5 Participants
44 Participants
n=4 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
1 Participants
n=4 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
3 Participants
n=7 Participants
0 Participants
n=5 Participants
3 Participants
n=4 Participants
Race (NIH/OMB)
White
19 Participants
n=5 Participants
18 Participants
n=7 Participants
7 Participants
n=5 Participants
44 Participants
n=4 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Region of Enrollment
United States
19 Participants
n=5 Participants
21 Participants
n=7 Participants
7 Participants
n=5 Participants
47 Participants
n=4 Participants

PRIMARY outcome

Timeframe: Up to 2 years

ORR is defined as the proportion of patients who have achieved Complete Response (CR) - disappearance of all target lesions or Partial Response (PR) - \>=30% decrease in the sum of the longest diameter of target lesions according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1; Overall Response (OR) = CR + PR.

Outcome measures

Outcome measures
Measure
Group 1 (CYT107, Atezolizumab)
n=19 Participants
Patients receive CYT107 on days 1, 8, 15, and 22, and atezolizumab on day 8 of cycle 1. Following cycle 1, patients receive atezolizumab on day 1. Cycles with atezolizumab repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Atezolizumab: Given IV Glycosylated Recombinant Human Interleukin-7: Given IM
Group 2 (Atezolizumab)
n=21 Participants
Patients receive atezolizumab on day 1 of each cycle. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Atezolizumab: Given IV
Safety Run in Phase
n=7 Participants
Patients were not randomized; they were assigned to the experimental arm treatment (atezolizumab + CYT107). Patients receive CYT107 on days 1, 8, 15, and 22, and atezolizumab on day 8 of cycle 1. Following cycle 1, patients receive atezolizumab on day 1. Cycles with atezolizumab repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Atezolizumab: Given IV Glycosylated Recombinant Human Interleukin-7: Given IM
Objective Response Rate (ORR)
Partial Response (PR)
3 Participants
4 Participants
0 Participants
Objective Response Rate (ORR)
Complete Response (CR)
2 Participants
1 Participants
0 Participants
Objective Response Rate (ORR)
Combined total PR + CR
5 Participants
5 Participants
0 Participants

SECONDARY outcome

Timeframe: Up to 2 years

Population: The PD-L1 assay produced no data due to expired antibody. Stratification by PD-L1 expression levels in the tumor microenvironment cannot be reported.

CBR is defined as the percentage of patients with advanced or metastatic cancer who have achieved CR (disappearance of all target lesions), PR (\>=30% decrease in the sum of the longest diameter of target lesions), and stable disease (SD) (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression, taking as reference the smallest sum diameters of target lesions) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1; CBR = CR + PR + SD. Will also assess CBR in patients stratified by PD-L1 expression levels in the tumor microenvironment.

Outcome measures

Outcome measures
Measure
Group 1 (CYT107, Atezolizumab)
n=19 Participants
Patients receive CYT107 on days 1, 8, 15, and 22, and atezolizumab on day 8 of cycle 1. Following cycle 1, patients receive atezolizumab on day 1. Cycles with atezolizumab repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Atezolizumab: Given IV Glycosylated Recombinant Human Interleukin-7: Given IM
Group 2 (Atezolizumab)
n=21 Participants
Patients receive atezolizumab on day 1 of each cycle. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Atezolizumab: Given IV
Safety Run in Phase
n=7 Participants
Patients were not randomized; they were assigned to the experimental arm treatment (atezolizumab + CYT107). Patients receive CYT107 on days 1, 8, 15, and 22, and atezolizumab on day 8 of cycle 1. Following cycle 1, patients receive atezolizumab on day 1. Cycles with atezolizumab repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Atezolizumab: Given IV Glycosylated Recombinant Human Interleukin-7: Given IM
Clinical Benefit Rate (CBR) Measured by RECIST v1.1
Stable Disease (SD)
2 Participants
4 Participants
2 Participants
Clinical Benefit Rate (CBR) Measured by RECIST v1.1
Partial Response (PR)
3 Participants
4 Participants
0 Participants
Clinical Benefit Rate (CBR) Measured by RECIST v1.1
Complete Response (CR)
2 Participants
1 Participants
0 Participants
Clinical Benefit Rate (CBR) Measured by RECIST v1.1
Combined total CR + PR + SD
7 Participants
9 Participants
2 Participants

SECONDARY outcome

Timeframe: Time from start of treatment to time of progression or death, whichever occurs first, assessed up to 2 years.

Population: Patients without documented PD or death are censored at the last disease assessment date. The PD-L1 assay produced no data due to expired antibody. Stratification by PD-L1 expression levels in the tumor microenvironment cannot be reported.

Progression is defined, per RECIST v1.1, as a 20% increase in the sum of the longest diameter of target lesions (the sum must demonstrate an absolute increase of at least 5 mm), or the appearance of new lesions and/or unequivocal progression of non-target lesions. PFS will be summarized using Kaplan-Meier estimates. Will also assess PFS in patients stratified by PD-L1 expression levels in the tumor microenvironment.

Outcome measures

Outcome measures
Measure
Group 1 (CYT107, Atezolizumab)
n=19 Participants
Patients receive CYT107 on days 1, 8, 15, and 22, and atezolizumab on day 8 of cycle 1. Following cycle 1, patients receive atezolizumab on day 1. Cycles with atezolizumab repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Atezolizumab: Given IV Glycosylated Recombinant Human Interleukin-7: Given IM
Group 2 (Atezolizumab)
n=21 Participants
Patients receive atezolizumab on day 1 of each cycle. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Atezolizumab: Given IV
Safety Run in Phase
n=7 Participants
Patients were not randomized; they were assigned to the experimental arm treatment (atezolizumab + CYT107). Patients receive CYT107 on days 1, 8, 15, and 22, and atezolizumab on day 8 of cycle 1. Following cycle 1, patients receive atezolizumab on day 1. Cycles with atezolizumab repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Atezolizumab: Given IV Glycosylated Recombinant Human Interleukin-7: Given IM
Progression-free Survival (PFS)
2.1 months
Interval 1.2 to 6.1
2.2 months
Interval 1.8 to 4.6
2.1 months
Interval 1.1 to 4.0

SECONDARY outcome

Timeframe: Time interval between the date of first response (CR/PR) and the date of progression, assessed up to 2 years.

Population: The PD-L1 assay produced no data due to expired antibody. Stratification by PD-L1 expression levels in the tumor microenvironment cannot be reported.

DOR is measured by RECIST v1.1. DOR will be summarized using Kaplan-Meier estimates. Will also assess DOR in patients stratified by PD-L1 expression levels in the tumor microenvironment.

Outcome measures

Outcome measures
Measure
Group 1 (CYT107, Atezolizumab)
n=19 Participants
Patients receive CYT107 on days 1, 8, 15, and 22, and atezolizumab on day 8 of cycle 1. Following cycle 1, patients receive atezolizumab on day 1. Cycles with atezolizumab repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Atezolizumab: Given IV Glycosylated Recombinant Human Interleukin-7: Given IM
Group 2 (Atezolizumab)
n=21 Participants
Patients receive atezolizumab on day 1 of each cycle. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Atezolizumab: Given IV
Safety Run in Phase
Patients were not randomized; they were assigned to the experimental arm treatment (atezolizumab + CYT107). Patients receive CYT107 on days 1, 8, 15, and 22, and atezolizumab on day 8 of cycle 1. Following cycle 1, patients receive atezolizumab on day 1. Cycles with atezolizumab repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Atezolizumab: Given IV Glycosylated Recombinant Human Interleukin-7: Given IM
Duration of Response (DOR)
NA months
Interval 2.3 to
The medians and 95% CIs for DOR were calculated based on Kaplan-Meier estimates. The Kaplan-Meier curve does not cross the 50% probability; therefore, the median survival time could not be calculated. Insufficient events to calculate a reliable upper 95% CI.
NA months
Interval 4.0 to
The medians and 95% CIs for DOR were calculated based on Kaplan-Meier estimates. The Kaplan-Meier curve does not cross the 50% probability; therefore, the median survival time could not be calculated. Insufficient events to calculate a reliable upper 95% CI.

SECONDARY outcome

Timeframe: Time interval between start of treatment to death due to any cause, assessed up to 48 months.

Population: The PD-L1 assay produced no data due to expired antibody. Stratification by PD-L1 expression levels in the tumor microenvironment cannot be reported.

OS will be summarized using Kaplan-Meier estimates. Will also assess OS in patients stratified by PD-L1 expression levels in the tumor microenvironment.

Outcome measures

Outcome measures
Measure
Group 1 (CYT107, Atezolizumab)
n=19 Participants
Patients receive CYT107 on days 1, 8, 15, and 22, and atezolizumab on day 8 of cycle 1. Following cycle 1, patients receive atezolizumab on day 1. Cycles with atezolizumab repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Atezolizumab: Given IV Glycosylated Recombinant Human Interleukin-7: Given IM
Group 2 (Atezolizumab)
n=19 Participants
Patients receive atezolizumab on day 1 of each cycle. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Atezolizumab: Given IV
Safety Run in Phase
n=7 Participants
Patients were not randomized; they were assigned to the experimental arm treatment (atezolizumab + CYT107). Patients receive CYT107 on days 1, 8, 15, and 22, and atezolizumab on day 8 of cycle 1. Following cycle 1, patients receive atezolizumab on day 1. Cycles with atezolizumab repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Atezolizumab: Given IV Glycosylated Recombinant Human Interleukin-7: Given IM
Overall Survival (OS)
9.1 months
Interval 2.6 to
The medians and 95% CIs for OS were calculated based on Kaplan-Meier estimates. Insufficient events to calculate a reliable upper 95% CI.
10.4 months
Interval 4.7 to 20.7
4.5 months
Interval 1.1 to 9.8

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 2 years

The evaluation of the effect of the investigation treatment combination on the immune-bias of the tumor microenvironment, based upon baseline and post-baseline tumor biopsy comparisons of number, distribution, and phenotype of tumor-infiltrating cells; PD-L1 expression, and expression of Interferon gamma (IFN-gamma) and associated proinflammatory gene expression in the tumor microenvironment.

Outcome measures

Outcome data not reported

Adverse Events

Group 1 (CYT107, Atezolizumab)

Serious events: 13 serious events
Other events: 18 other events
Deaths: 11 deaths

Group 2 (Atezolizumab)

Serious events: 11 serious events
Other events: 19 other events
Deaths: 14 deaths

Safety Run in Phase

Serious events: 5 serious events
Other events: 7 other events
Deaths: 6 deaths

Serious adverse events

Serious adverse events
Measure
Group 1 (CYT107, Atezolizumab)
n=19 participants at risk
Patients receive CYT107 on days 1, 8, 15, and 22, and atezolizumab on day 8 of cycle 1. Following cycle 1, patients receive atezolizumab on day 1. Cycles with atezolizumab repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Atezolizumab: Given IV Glycosylated Recombinant Human Interleukin-7: Given IM
Group 2 (Atezolizumab)
n=19 participants at risk
Patients receive atezolizumab on day 1 of each cycle. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Atezolizumab: Given IV
Safety Run in Phase
n=7 participants at risk
Patients were not randomized; they were assigned to the experimental arm treatment (atezolizumab + CYT107). Patients receive CYT107 on days 1, 8, 15, and 22, and atezolizumab on day 8 of cycle 1. Following cycle 1, patients receive atezolizumab on day 1. Cycles with atezolizumab repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Atezolizumab: Given IV Glycosylated Recombinant Human Interleukin-7: Given IM
Blood and lymphatic system disorders
Anemia
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
15.8%
3/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
14.3%
1/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Cardiac disorders
Atrial Flutter
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Cardiac disorders
Myocardial Infarction
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
14.3%
1/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Gastrointestinal disorders
Colitis
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Gastrointestinal disorders
Esophageal Obstruction
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Gastrointestinal disorders
Nausea
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Gastrointestinal disorders
Pancreatitis
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Gastrointestinal disorders
Small Intestinal Obstruction
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
General disorders
Death NOS
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
General disorders
Disease Progression
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
14.3%
1/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
General disorders
Edema Limbs
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
General disorders
Fatigue
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
General disorders
Fever
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
14.3%
1/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
General disorders
Generalized Edema
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
General disorders
Non-Cardiac Chest Pain
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Infections and infestations
Enterocolitis Infectious
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Infections and infestations
Lung Infection
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
14.3%
1/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Infections and infestations
Sepsis
10.5%
2/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
14.3%
1/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Infections and infestations
Upper Respiratory Infection
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Infections and infestations
Urinary Tract Infection
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Investigations
Alanine Aminotransferase Increased
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Investigations
Aspartate Aminotransferase Increased
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Investigations
Blood Bilirubin Increased
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
14.3%
1/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Investigations
Creatinine Increased
10.5%
2/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Investigations
Lipase Increased
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Investigations
Serum Amylase Increased
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Metabolism and nutrition disorders
Hypercalcemia
10.5%
2/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
14.3%
1/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Metabolism and nutrition disorders
Hyperkalemia
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
14.3%
1/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Metabolism and nutrition disorders
Hyponatremia
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
14.3%
1/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Musculoskeletal and connective tissue disorders
Back Pain
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
10.5%
2/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
14.3%
1/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Musculoskeletal and connective tissue disorders
Bone Pain
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Musculoskeletal and connective tissue disorders
Flank Pain
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Progressive Disease
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
14.3%
1/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Nervous system disorders
Concentration Impairment
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Nervous system disorders
Encephalopathy
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Nervous system disorders
Peripheral Motor Neuropathy
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Nervous system disorders
Stroke
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Nervous system disorders
Syncope
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Renal and urinary disorders
Acute Kidney Injury
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
15.8%
3/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Renal and urinary disorders
Acute Tubular Necrosis
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Renal and urinary disorders
Cystitis Noninfective
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Renal and urinary disorders
Hematuria
10.5%
2/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
10.5%
2/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
14.3%
1/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Renal and urinary disorders
Urinary Retention
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Renal and urinary disorders
Urinary Tract Obstruction
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Renal and urinary disorders
Urosepsis
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Reproductive system and breast disorders
Pelvic Pain
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Respiratory, thoracic and mediastinal disorders
Dyspnea
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
14.3%
1/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Respiratory, thoracic and mediastinal disorders
Hypoxia
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Vascular disorders
Deep Vein Thrombosis
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Vascular disorders
Hypotension
10.5%
2/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Vascular disorders
Thromboembolic Event
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
14.3%
1/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.

Other adverse events

Other adverse events
Measure
Group 1 (CYT107, Atezolizumab)
n=19 participants at risk
Patients receive CYT107 on days 1, 8, 15, and 22, and atezolizumab on day 8 of cycle 1. Following cycle 1, patients receive atezolizumab on day 1. Cycles with atezolizumab repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Atezolizumab: Given IV Glycosylated Recombinant Human Interleukin-7: Given IM
Group 2 (Atezolizumab)
n=19 participants at risk
Patients receive atezolizumab on day 1 of each cycle. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Atezolizumab: Given IV
Safety Run in Phase
n=7 participants at risk
Patients were not randomized; they were assigned to the experimental arm treatment (atezolizumab + CYT107). Patients receive CYT107 on days 1, 8, 15, and 22, and atezolizumab on day 8 of cycle 1. Following cycle 1, patients receive atezolizumab on day 1. Cycles with atezolizumab repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Atezolizumab: Given IV Glycosylated Recombinant Human Interleukin-7: Given IM
Infections and infestations
Urinary Tract Infection
21.1%
4/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
10.5%
2/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Blood and lymphatic system disorders
Anemia
36.8%
7/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
42.1%
8/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
42.9%
3/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Blood and lymphatic system disorders
DVT
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Blood and lymphatic system disorders
Eosinophilia
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
10.5%
2/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Blood and lymphatic system disorders
Hypervolemia
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Cardiac disorders
Chest Pain - Cardiac
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Cardiac disorders
Diastolic Dysfunction
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Cardiac disorders
Heart Failure
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Cardiac disorders
Sinus Bradycardia
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
10.5%
2/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Cardiac disorders
Sinus Tachycardia
15.8%
3/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Cardiac disorders
Supraventricular Tachycardia
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Ear and labyrinth disorders
Ear Pain
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
14.3%
1/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Ear and labyrinth disorders
Right Ear Impaction
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Endocrine disorders
Hyperparathyroidism
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Endocrine disorders
Hypothyroidism
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Eye disorders
Blurred Vision
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Eye disorders
Floaters
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Eye disorders
Itchy Eyes
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Eye disorders
Tunnel Vision
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Gastrointestinal disorders
Abdominal Pain
10.5%
2/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
36.8%
7/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Gastrointestinal disorders
Anal Pain
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Gastrointestinal disorders
Ascites
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Gastrointestinal disorders
Bloating
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Gastrointestinal disorders
Colonic Obstruction
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Gastrointestinal disorders
Constipation
42.1%
8/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
31.6%
6/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
14.3%
1/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Gastrointestinal disorders
Diarrhea
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
42.1%
8/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
14.3%
1/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Gastrointestinal disorders
Dry Mouth
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
14.3%
1/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Gastrointestinal disorders
Dyspepsia
10.5%
2/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Gastrointestinal disorders
Dysphagia
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Gastrointestinal disorders
Esophageal Pain
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Gastrointestinal disorders
Fecal Incontinence
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Gastrointestinal disorders
Flatulence
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Gastrointestinal disorders
Gastroesophageal Reflux Disease
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Gastrointestinal disorders
Mucositis Oral
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
14.3%
1/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Gastrointestinal disorders
Nausea
36.8%
7/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
15.8%
3/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
57.1%
4/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Gastrointestinal disorders
Toothache
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Gastrointestinal disorders
Vomiting
15.8%
3/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
57.1%
4/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
General disorders
Bilateral Pulmonary Emboli
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
General disorders
Chills
21.1%
4/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
28.6%
2/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
General disorders
DVT
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
General disorders
Edema Limbs
10.5%
2/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
14.3%
1/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
General disorders
Fatigue
57.9%
11/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
42.1%
8/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
42.9%
3/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
General disorders
Fever
21.1%
4/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
10.5%
2/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
42.9%
3/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
General disorders
Generalized Edema
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
General disorders
Hydronephrosis
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
General disorders
Hypochloremia
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
General disorders
Increased Prothrombin
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
General disorders
Injection Site Reaction
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
14.3%
1/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
General disorders
Non-Cardiac Chest Pain
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
14.3%
1/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
General disorders
Pain
15.8%
3/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
10.5%
2/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
14.3%
1/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
General disorders
Physical Deconditioning
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
General disorders
Redness at Injection Site
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
General disorders
Shaking/Shivering
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
14.3%
1/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
General disorders
Swelling at Injection Site
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Infections and infestations
Abdominal Infection
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Infections and infestations
Autoimmune Hepatitis
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Infections and infestations
Covid
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Infections and infestations
Lung Infection
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Infections and infestations
Oral Candidiasis
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Infections and infestations
Sepsis
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Infections and infestations
Skin Infection
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Infections and infestations
Tooth Infection
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Infections and infestations
Upper Respiratory Infection
10.5%
2/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Injury, poisoning and procedural complications
Bruising
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Injury, poisoning and procedural complications
Fall
21.1%
4/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Injury, poisoning and procedural complications
Fracture
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Injury, poisoning and procedural complications
Hip Fracture
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Injury, poisoning and procedural complications
Infusion Related Reaction
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
14.3%
1/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Injury, poisoning and procedural complications
Spinal Fracture
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
14.3%
1/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Investigations
Activated Partial Thromboplastin Time Prolonged
15.8%
3/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Investigations
Alanine Aminotransferase Increased
21.1%
4/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
14.3%
1/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Investigations
Alkaline Phosphatase Increased
31.6%
6/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
15.8%
3/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
42.9%
3/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Investigations
aPTT Decreased
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Investigations
Aspartate Aminotransferase Increased
21.1%
4/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
10.5%
2/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
28.6%
2/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Investigations
Blood Bilirubin Increased
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Investigations
Blood Lactate Dehydrogenase Increased
10.5%
2/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
10.5%
2/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Investigations
BUN Increased
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Investigations
CD4 Lymphocytes Decreased
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Investigations
CD8 Lymphocytes Decreased
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Investigations
Creatinine Increased
47.4%
9/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
31.6%
6/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
42.9%
3/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Investigations
Elevated BUN
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
10.5%
2/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Investigations
Hemoglobin Increased
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Investigations
Hypochloremia
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Investigations
Increased BUN
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Investigations
INR Increased
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
21.1%
4/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Investigations
Lactic Acid Increased
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Investigations
LDH Increased
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Investigations
Lipase Increased
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Investigations
Lymphocyte Count Decreased
15.8%
3/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
21.1%
4/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Investigations
Lymphocyte Count Increased
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Investigations
Monocytosis
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Investigations
Neutrophil Count Decreased
10.5%
2/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
10.5%
2/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Investigations
Neutrophilia
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Investigations
Platelet Count Decreased
10.5%
2/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
26.3%
5/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Investigations
Prolonged Prothrombin Time
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Investigations
Shoulder Pain
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Investigations
Thrombocytosis
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Investigations
Thyroid Stimulating Hormone Increased
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Investigations
Total Protein Elevated
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Investigations
WBC Increased
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Investigations
Weight Loss
10.5%
2/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Investigations
White Blood Cell Decreased
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
21.1%
4/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Metabolism and nutrition disorders
Anorexia
26.3%
5/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
26.3%
5/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
14.3%
1/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Metabolism and nutrition disorders
Dehydration
10.5%
2/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Metabolism and nutrition disorders
Hypercalcemia
15.8%
3/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Metabolism and nutrition disorders
Hyperglycemia
10.5%
2/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
15.8%
3/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Metabolism and nutrition disorders
Hyperkalemia
26.3%
5/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Metabolism and nutrition disorders
Hypermagnesemia
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Metabolism and nutrition disorders
Hyperphosphatemia
10.5%
2/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Metabolism and nutrition disorders
Hypoalbuminemia
31.6%
6/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
26.3%
5/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
14.3%
1/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Metabolism and nutrition disorders
Hypocalcemia
15.8%
3/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
10.5%
2/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
14.3%
1/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Metabolism and nutrition disorders
Hypokalemia
15.8%
3/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
21.1%
4/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
14.3%
1/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Metabolism and nutrition disorders
Hypomagnesemia
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
28.6%
2/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Metabolism and nutrition disorders
Hyponatremia
36.8%
7/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
36.8%
7/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
14.3%
1/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Metabolism and nutrition disorders
Hypophosphatemia
10.5%
2/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Musculoskeletal and connective tissue disorders
Arthralgia
15.8%
3/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
15.8%
3/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
14.3%
1/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Musculoskeletal and connective tissue disorders
Back Pain
10.5%
2/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
10.5%
2/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
28.6%
2/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Musculoskeletal and connective tissue disorders
Bone Pain
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Musculoskeletal and connective tissue disorders
Chest Wall Pain
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Musculoskeletal and connective tissue disorders
Flank Pain
21.1%
4/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
10.5%
2/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
10.5%
2/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
14.3%
1/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Musculoskeletal and connective tissue disorders
Joint Range of Motion Decreased
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Musculoskeletal and connective tissue disorders
Muscle Cramp
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Musculoskeletal and connective tissue disorders
Muscle Weakness Lower Limb
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Musculoskeletal and connective tissue disorders
Neck Pain
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Musculoskeletal and connective tissue disorders
Pain in Extremity
15.8%
3/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
14.3%
1/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Musculoskeletal and connective tissue disorders
Rotator Cuff Injury
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Musculoskeletal and connective tissue disorders
Trigger Finger, Left Hand
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain Mets
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Nervous system disorders
Dizziness
15.8%
3/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
14.3%
1/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Nervous system disorders
Dysgeusia
10.5%
2/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Nervous system disorders
Encephalopathy
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Renal and urinary disorders
Urinary Incontinence
10.5%
2/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Nervous system disorders
Headache
31.6%
6/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Nervous system disorders
Memory Impairment
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Nervous system disorders
Neuralgia
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Nervous system disorders
Paresthesia
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Nervous system disorders
Peripheral Motor Neuropathy
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Nervous system disorders
Peripheral Sensory Neuropathy
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
14.3%
1/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Nervous system disorders
Spasticity
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Psychiatric disorders
Anxiety
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
14.3%
1/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Psychiatric disorders
Confusion
10.5%
2/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Psychiatric disorders
Depression
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Psychiatric disorders
Distracted and Forgetful
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Psychiatric disorders
Insomnia
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Renal and urinary disorders
Acute Kidney Injury
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Renal and urinary disorders
Bladder Spasm
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Renal and urinary disorders
Chronic Kidney Disease
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Renal and urinary disorders
Dysuria
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Renal and urinary disorders
Hematuria
15.8%
3/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Renal and urinary disorders
Hydroneprosis
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Renal and urinary disorders
Nephrostomy Dislodgment
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Renal and urinary disorders
Nocturia - Intermittent
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Renal and urinary disorders
Renal Injury
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Renal and urinary disorders
Urinary Tract Obstruction
10.5%
2/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
14.3%
1/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Renal and urinary disorders
Urinary Urgency
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Renal and urinary disorders
Urine Discoloration
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Reproductive system and breast disorders
Pelvic Pain
10.5%
2/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Reproductive system and breast disorders
Perineal Pain
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Respiratory, thoracic and mediastinal disorders
Aspiration
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Respiratory, thoracic and mediastinal disorders
Cough
21.1%
4/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Respiratory, thoracic and mediastinal disorders
Dyspnea
10.5%
2/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
10.5%
2/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
28.6%
2/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
10.5%
2/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Respiratory, thoracic and mediastinal disorders
Sore Throat
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Respiratory, thoracic and mediastinal disorders
Wheezing
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Skin and subcutaneous tissue disorders
Dry Skin
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
10.5%
2/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Skin and subcutaneous tissue disorders
Eczema
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Skin and subcutaneous tissue disorders
Hyperhidrosis
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
14.3%
1/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Skin and subcutaneous tissue disorders
Hyperkeratosis
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Skin and subcutaneous tissue disorders
Itching and Discomfort Around Ostomy/Stoma
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Skin and subcutaneous tissue disorders
Night Sweats
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Skin and subcutaneous tissue disorders
Ostomy/Stome
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Skin and subcutaneous tissue disorders
Pain of Skin
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
14.3%
1/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Skin and subcutaneous tissue disorders
Photosensitivity
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Skin and subcutaneous tissue disorders
Possible Folliculitis/Rash Around Stoma
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Skin and subcutaneous tissue disorders
Pruritus
26.3%
5/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
10.5%
2/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
14.3%
1/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Skin and subcutaneous tissue disorders
Rash Acneiform
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
28.6%
2/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
21.1%
4/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
15.8%
3/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
14.3%
1/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Skin and subcutaneous tissue disorders
Skin Hyperpigmentation
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Skin and subcutaneous tissue disorders
Skin Ulceration
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Skin and subcutaneous tissue disorders
Slight Itch All Over Body
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Skin and subcutaneous tissue disorders
Stoma/Ostomy
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Skin and subcutaneous tissue disorders
Sun Burn Blisters
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Skin and subcutaneous tissue disorders
Suspicious for SCC
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Skin and subcutaneous tissue disorders
Tissue Sloughing
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
14.3%
1/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Vascular disorders
Hypertension
10.5%
2/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
21.1%
4/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
28.6%
2/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Vascular disorders
Hypotension
21.1%
4/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
10.5%
2/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Vascular disorders
Lymphedema
5.3%
1/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
Vascular disorders
Thromboembolic Event
10.5%
2/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
0.00%
0/19 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.
14.3%
1/7 • Serious Adverse Events and other (not including serious) adverse events were assessed for up to 30 days post-treatment. All-cause mortality was assessed for up to 48 months.
Two patients randomized in Group 2 (Atezolizumab) did not receive any study treatment, therefore the total number of participants at risk in the Serious Adverse Events and other (not including serious) adverse events tables were adjusted accordingly.

Additional Information

Cancer Immunotherapy Trials Network Trial Manager

Fred Hutchinson Cancer Center

Phone: 514-718-2858

Results disclosure agreements

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

Restriction type: LTE60