Trial Outcomes & Findings for A Study of Tiragolumab Plus Atezolizumab and Atezolizumab Monotherapy in Participants With Metastatic and/or Recurrent PD-L1-Positive Cervical Cancer (NCT NCT04300647)
NCT ID: NCT04300647
Last Updated: 2025-03-20
Results Overview
ORR is defined as the percentage of participants with a complete response (CR) or a partial response (PR) on two consecutive occasions \>/=4 weeks apart, as determined by the IRC according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. The study enrolled patients with measurable disease as determined by the investigator. Participants found to have non-measurable disease at baseline according to RECIST v1.1 (through IRC assessment or Protocol Deviations) were only considered responders if they achieved a CR.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
172 participants
Primary outcome timeframe
From randomization up to approximately 17 months
Results posted on
2025-03-20
Participant Flow
This study was conducted at 59 centers in 17 countries. The study enrolled 172 participants of whom 171 were included in the Treated Population reported here. The study is ongoing. Data up to primary completion date is reported here.
Subjects with PDL1-positive cervical cancer were randomized in a 3:1 ratio to receive either atezolizumab plus tiragolumab or atezolizumab monotherapy with the use of a stratified permuted-block randomization based on Eastern Cooperative Oncology Group (ECOG) Performance Status, prior use of chemoradiotherapy or radiotherapy, and treatment history.
Participant milestones
| Measure |
Atezolizumab
Participants received atezolizumab monotherapy until disease progression, loss of clinical benefit, or unacceptable toxicity as determined by the investigator.
|
Tiragolumab Plus Atezolizumab
Participants received tiragolumab and atezolizumab until disease progression, loss of clinical benefit, or unacceptable toxicity as determined by the investigator.
|
Post Crossover Tiragolumab Plus Atezolizumab
After unequivocal progressive disease had been recorded during atezolizumab monotherapy, crossover was allowed from the atezolizumab monotherapy arm to the tiragolumab plus atezolizumab arm at the discretion of the investigator and after consultation with the Medical Monitor.
|
|---|---|---|---|
|
Pre-Crossover
STARTED
|
45
|
126
|
0
|
|
Pre-Crossover
COMPLETED
|
0
|
0
|
0
|
|
Pre-Crossover
NOT COMPLETED
|
45
|
126
|
0
|
|
Post-Crossover
STARTED
|
0
|
0
|
13
|
|
Post-Crossover
COMPLETED
|
0
|
0
|
0
|
|
Post-Crossover
NOT COMPLETED
|
0
|
0
|
13
|
Reasons for withdrawal
| Measure |
Atezolizumab
Participants received atezolizumab monotherapy until disease progression, loss of clinical benefit, or unacceptable toxicity as determined by the investigator.
|
Tiragolumab Plus Atezolizumab
Participants received tiragolumab and atezolizumab until disease progression, loss of clinical benefit, or unacceptable toxicity as determined by the investigator.
|
Post Crossover Tiragolumab Plus Atezolizumab
After unequivocal progressive disease had been recorded during atezolizumab monotherapy, crossover was allowed from the atezolizumab monotherapy arm to the tiragolumab plus atezolizumab arm at the discretion of the investigator and after consultation with the Medical Monitor.
|
|---|---|---|---|
|
Pre-Crossover
Death
|
19
|
58
|
0
|
|
Pre-Crossover
Lost to Follow-up
|
0
|
3
|
0
|
|
Pre-Crossover
Withdrawal by Subject
|
2
|
4
|
0
|
|
Pre-Crossover
On-going in Study
|
24
|
61
|
0
|
|
Post-Crossover
Death
|
0
|
0
|
3
|
|
Post-Crossover
Lost to Follow-up
|
0
|
0
|
1
|
|
Post-Crossover
Withdrawal by Subject
|
0
|
0
|
1
|
|
Post-Crossover
On-going in Study
|
0
|
0
|
8
|
Baseline Characteristics
A Study of Tiragolumab Plus Atezolizumab and Atezolizumab Monotherapy in Participants With Metastatic and/or Recurrent PD-L1-Positive Cervical Cancer
Baseline characteristics by cohort
| Measure |
Atezolizumab
n=45 Participants
Participants received atezolizumab monotherapy until disease progression, loss of clinical benefit, or unacceptable toxicity as determined by the investigator.
|
Tiragolumab Plus Atezolizumab
n=126 Participants
Participants received tiragolumab and atezolizumab until disease progression, loss of clinical benefit, or unacceptable toxicity as determined by the investigator.
|
Total
n=171 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.0 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
50.8 years
STANDARD_DEVIATION 11.8 • n=7 Participants
|
50.9 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=5 Participants
|
126 Participants
n=7 Participants
|
171 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
22 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
ECOG Performance Status
ECOG Performance Status 0
|
23 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
ECOG Performance Status
ECOG Performance Status 1
|
22 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Prior Use of Chemoradiotherapy or Radiotherapy
Yes
|
36 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
134 Participants
n=5 Participants
|
|
Prior Use of Chemoradiotherapy or Radiotherapy
No
|
9 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Treatment History
Recurrent Disease
|
26 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
|
Treatment History
Persistent Disease
|
19 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From randomization up to approximately 17 monthsPopulation: The Treated Population was defined as all randomized participants that received at least any dose of study treatment. Participants are grouped according to the actual treatment received.
ORR is defined as the percentage of participants with a complete response (CR) or a partial response (PR) on two consecutive occasions \>/=4 weeks apart, as determined by the IRC according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. The study enrolled patients with measurable disease as determined by the investigator. Participants found to have non-measurable disease at baseline according to RECIST v1.1 (through IRC assessment or Protocol Deviations) were only considered responders if they achieved a CR.
Outcome measures
| Measure |
Atezolizumab
n=45 Participants
Participants received atezolizumab monotherapy until disease progression, loss of clinical benefit, or unacceptable toxicity as determined by the investigator.
|
Tiragolumab Plus Atezolizumab
n=126 Participants
Participants received tiragolumab and atezolizumab until disease progression, loss of clinical benefit, or unacceptable toxicity as determined by the investigator.
|
|---|---|---|
|
Independent Review Committee (IRC)-Assessed Objective Response Rate (ORR)
|
15.6 percentage of participants
Interval 6.5 to 29.5
|
19.0 percentage of participants
Interval 12.6 to 27.0
|
SECONDARY outcome
Timeframe: Up to 36 monthsAn adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: First occurrence of a documented objective response to the date of disease progression or death from any cause, whichever occurs first (up to approximately 17 months)Population: The Treated Population was defined as all randomized participants that received at least any dose of study treatment. Participants are grouped according to the actual treatment received. DOR was assessed in participants with an objective response.
DOR is defined for participants who had an objective response as the time from the first occurrence of a documented objective response (CR or PR) to the date of progressive disease (PD) or death from any cause (whichever occurred first), as determined by the IRC according to RECIST v1.1. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters at prior timepoints (including baseline). The study enrolled patients with measurable disease as determined by the investigator. Participants found to have non-measurable disease at baseline according to RECIST v1.1 (through IRC assessment or Protocol Deviations) were only considered responders if they achieved a CR.
Outcome measures
| Measure |
Atezolizumab
n=7 Participants
Participants received atezolizumab monotherapy until disease progression, loss of clinical benefit, or unacceptable toxicity as determined by the investigator.
|
Tiragolumab Plus Atezolizumab
n=24 Participants
Participants received tiragolumab and atezolizumab until disease progression, loss of clinical benefit, or unacceptable toxicity as determined by the investigator.
|
|---|---|---|
|
IRC-Assessed Duration of Response (DOR)
|
NA months
Interval 6.5 to
NA: the median duration of ORR was not reached due to low number of participants with events.
|
11.8 months
Interval 6.7 to
Na: not estimable due to low number of participants with events.
|
SECONDARY outcome
Timeframe: From randomization up to approximately 17 monthsPopulation: The Treated Population was defined as all randomized participants that received at least any dose of study treatment. Participants are grouped according to the actual treatment received.
Disease control rate is defined as the percentage of participants with a CR, PR, or stable disease (SD), as determined by the IRC according to RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. SD: neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD. Participants were classified as SD only if SD was observed on two consecutive assessments \>/= 6 weeks apart. The study enrolled patients with measurable disease as determined by the investigator. Participants found to have non-measurable disease at baseline according to RECIST v1.1 (through IRC assessment or Protocol Deviations) were only considered responders if they achieved a CR.
Outcome measures
| Measure |
Atezolizumab
n=45 Participants
Participants received atezolizumab monotherapy until disease progression, loss of clinical benefit, or unacceptable toxicity as determined by the investigator.
|
Tiragolumab Plus Atezolizumab
n=126 Participants
Participants received tiragolumab and atezolizumab until disease progression, loss of clinical benefit, or unacceptable toxicity as determined by the investigator.
|
|---|---|---|
|
IRC-Assessed Disease Control Rate (DCR)
|
20.0 percentage of participants
Interval 9.6 to 34.6
|
31.0 percentage of participants
Interval 23.0 to 39.8
|
SECONDARY outcome
Timeframe: From randomization up to approximately 17 monthsPopulation: The Treated Population was defined as all randomized participants that received at least any dose of study treatment. Participants are grouped according to the actual treatment received.
BCR is defined as the percentage of participants with a CR, PR, or SD, as determined by the investigator. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. SD: neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD. Participants were classified as SD only if SD was observed on two consecutive assessments \>/= 6 weeks apart.
Outcome measures
| Measure |
Atezolizumab
n=45 Participants
Participants received atezolizumab monotherapy until disease progression, loss of clinical benefit, or unacceptable toxicity as determined by the investigator.
|
Tiragolumab Plus Atezolizumab
n=126 Participants
Participants received tiragolumab and atezolizumab until disease progression, loss of clinical benefit, or unacceptable toxicity as determined by the investigator.
|
|---|---|---|
|
Investigator-Assessed Best Clinical Response (BCR) Rate
|
33.3 percentage of participants
Interval 20.0 to 49.0
|
44.4 percentage of participants
Interval 35.6 to 53.6
|
SECONDARY outcome
Timeframe: First occurrence of a documented clinical response to the date of disease progression or death from any cause, whichever occurs first (up to approximately 17 months)Population: The Treated Population was defined as all randomized participants that received at least any dose of study treatment. Participants are grouped according to the actual treatment received. Duration of BCR was assessed in participants with a clinical response.
Duration of BCR is defined for BCR responders as the time from the first occurrence of a documented response (CR, PR, or SD) to the date of PD or death from any cause (whichever occurred first), as clinically determined by the investigator according to RECIST v1.1. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. SD: neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD. Participants were classified as SD only if SD was observed on two consecutive assessments \>/= 6 weeks apart. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters at prior timepoints (including baseline).
Outcome measures
| Measure |
Atezolizumab
n=15 Participants
Participants received atezolizumab monotherapy until disease progression, loss of clinical benefit, or unacceptable toxicity as determined by the investigator.
|
Tiragolumab Plus Atezolizumab
n=56 Participants
Participants received tiragolumab and atezolizumab until disease progression, loss of clinical benefit, or unacceptable toxicity as determined by the investigator.
|
|---|---|---|
|
Investigator-Assessed Duration of BCR
|
7.0 months
Interval 5.6 to
NA: not estimable due to low number of events.
|
5.5 months
Interval 4.2 to 8.7
|
SECONDARY outcome
Timeframe: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 17 months)Population: The Treated Population was defined as all randomized participants that received at least any dose of study treatment. Participants are grouped according to the actual treatment received.
PFS is defined as the time from randomization to the first occurrence of PD or death from any cause (whichever occurred first), as determined by the IRC according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline).
Outcome measures
| Measure |
Atezolizumab
n=45 Participants
Participants received atezolizumab monotherapy until disease progression, loss of clinical benefit, or unacceptable toxicity as determined by the investigator.
|
Tiragolumab Plus Atezolizumab
n=126 Participants
Participants received tiragolumab and atezolizumab until disease progression, loss of clinical benefit, or unacceptable toxicity as determined by the investigator.
|
|---|---|---|
|
IRC-Assessed Progression-Free Survival (PFS)
|
1.9 months
Interval 1.5 to 3.0
|
2.8 months
Interval 1.7 to 4.1
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: The Treated Population was defined as all randomized participants that received at least any dose of study treatment. Participants are grouped according to the actual treatment received. Overall number analyzed are number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at specified timepoints
PFS rate is defined as the percentage of participants that were event free, as determined by the IRC according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline).
Outcome measures
| Measure |
Atezolizumab
n=9 Participants
Participants received atezolizumab monotherapy until disease progression, loss of clinical benefit, or unacceptable toxicity as determined by the investigator.
|
Tiragolumab Plus Atezolizumab
n=34 Participants
Participants received tiragolumab and atezolizumab until disease progression, loss of clinical benefit, or unacceptable toxicity as determined by the investigator.
|
|---|---|---|
|
IRC-Assessed PFS Rate at 6 Months
|
21.50 percentage of participants
Interval 9.06 to 33.94
|
30.56 percentage of participants
Interval 22.29 to 38.83
|
SECONDARY outcome
Timeframe: From randomization to death from any cause (up to approximately 17 months)Population: The Treated Population was defined as all randomized participants that received at least any dose of study treatment. Participants are grouped according to the actual treatment received.
OS is defined as the time of randomization to death from any cause.
Outcome measures
| Measure |
Atezolizumab
n=45 Participants
Participants received atezolizumab monotherapy until disease progression, loss of clinical benefit, or unacceptable toxicity as determined by the investigator.
|
Tiragolumab Plus Atezolizumab
n=126 Participants
Participants received tiragolumab and atezolizumab until disease progression, loss of clinical benefit, or unacceptable toxicity as determined by the investigator.
|
|---|---|---|
|
Overall Survival (OS)
|
10.6 months
Interval 7.4 to
The upper limit of the 95% CI was not estimable due to insufficient number of participants with events.
|
11.0 months
Interval 9.6 to
The upper limit of the 95% CI was not estimable due to insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: 6 months, 12 monthsPopulation: The Treated Population was defined as all randomized participants that received at least any dose of study treatment. Overall number analyzed are number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at specified timepoints.
Reported here are the percentages of participants who were still alive at 6 months and 12 months.
Outcome measures
| Measure |
Atezolizumab
n=26 Participants
Participants received atezolizumab monotherapy until disease progression, loss of clinical benefit, or unacceptable toxicity as determined by the investigator.
|
Tiragolumab Plus Atezolizumab
n=86 Participants
Participants received tiragolumab and atezolizumab until disease progression, loss of clinical benefit, or unacceptable toxicity as determined by the investigator.
|
|---|---|---|
|
OS Rate at 6 Months and 12 Months
6 Months
|
69.49 percentage of participants
Interval 55.52 to 83.47
|
73.56 percentage of participants
Interval 65.69 to 81.44
|
|
OS Rate at 6 Months and 12 Months
12 Months
|
37.88 percentage of participants
Interval 17.38 to 58.38
|
47.19 percentage of participants
Interval 36.63 to 57.76
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre dose: Day 1 of Cycles 2, 3, 4, 8, 12 and 16Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Cycle 1 Day 1 at 30 minutes post-doseOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre dose: Day 1 of Cycles 2, 3, 4, 8, 12 and 16Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 of Cycle 1 at 30 minutes post-doseOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Predose on Day 1 of Cycles (each cycle is 21 days) 1, 2, 3, 4, 8, 12 and 16Participants were classified as treatment-emergent ADA-positive if they were ADA negative at baseline or missing data but developed an ADA response following study drug administration (treatment-induced ADA response) or if they were ADA-positive at baseline and the titre of one or more post-baseline samples was at least 4-fold greater (i.e., ≥ 0.60 titre units) than the titre of the baseline sample (treatment-enhanced ADA response).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Predose on Day 1 of Cycles (each cycle is 21 days) 1, 2, 3, 4, 8, 12 and 16Participants were classified as treatment-emergent ADA-positive if they were ADA negative at baseline or missing data but developed an ADA response following study drug administration (treatment-induced ADA response) or if they were ADA-positive at baseline and the titre of one or more post-baseline samples was at least 4-fold greater (i.e., ≥ 0.60 titre units) than the titre of the baseline sample (treatment-enhanced ADA response).
Outcome measures
Outcome data not reported
Adverse Events
Atezolizumab
Serious events: 12 serious events
Other events: 36 other events
Deaths: 19 deaths
Tiragolumab Plus Atezolizumab
Serious events: 37 serious events
Other events: 108 other events
Deaths: 58 deaths
Post Crossover Tiragolumab Plus Atezolizumab
Serious events: 0 serious events
Other events: 9 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Atezolizumab
n=45 participants at risk
Participants received atezolizumab monotherapy until disease progression, loss of clinical benefit, or unacceptable toxicity as determined by the investigator.
|
Tiragolumab Plus Atezolizumab
n=126 participants at risk
Participants received tiragolumab and atezolizumab until disease progression, loss of clinical benefit, or unacceptable toxicity as determined by the investigator.
|
Post Crossover Tiragolumab Plus Atezolizumab
n=13 participants at risk
After unequivocal progressive disease had been recorded during atezolizumab monotherapy, crossover was allowed from the atezolizumab monotherapy arm to the tiragolumab plus atezolizumab arm at the discretion of the investigator and after consultation with the Medical Monitor.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
4.4%
2/45 • Number of events 2 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
2.4%
3/126 • Number of events 6 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/45 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.79%
1/126 • Number of events 1 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.00%
0/45 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.79%
1/126 • Number of events 1 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Cardiac disorders
Sinus tachycardia
|
2.2%
1/45 • Number of events 1 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/126 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/45 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.79%
1/126 • Number of events 1 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/45 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.79%
1/126 • Number of events 1 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Gastrointestinal disorders
Ileal stenosis
|
0.00%
0/45 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.79%
1/126 • Number of events 1 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/45 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.79%
1/126 • Number of events 1 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/45 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.79%
1/126 • Number of events 1 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
General disorders
Fatigue
|
0.00%
0/45 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.79%
1/126 • Number of events 1 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
General disorders
Hyperpyrexia
|
0.00%
0/45 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.79%
1/126 • Number of events 1 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
General disorders
Oedema peripheral
|
2.2%
1/45 • Number of events 1 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/126 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
General disorders
Pyrexia
|
0.00%
0/45 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
1.6%
2/126 • Number of events 3 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.00%
0/45 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.79%
1/126 • Number of events 1 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/45 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.79%
1/126 • Number of events 1 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Immune system disorders
Sarcoidosis
|
0.00%
0/45 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.79%
1/126 • Number of events 1 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Infections and infestations
Abdominal abscess
|
2.2%
1/45 • Number of events 1 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/126 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Infections and infestations
Encephalitis
|
0.00%
0/45 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.79%
1/126 • Number of events 1 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Infections and infestations
Enterococcal sepsis
|
0.00%
0/45 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.79%
1/126 • Number of events 1 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/45 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.79%
1/126 • Number of events 1 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Infections and infestations
Infection
|
0.00%
0/45 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.79%
1/126 • Number of events 1 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/45 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.79%
1/126 • Number of events 1 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Infections and infestations
Pelvic abscess
|
0.00%
0/45 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.79%
1/126 • Number of events 1 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Infections and infestations
Pneumonia
|
2.2%
1/45 • Number of events 1 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/126 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Infections and infestations
Pyelitis
|
0.00%
0/45 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.79%
1/126 • Number of events 1 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Infections and infestations
Pyelonephritis
|
2.2%
1/45 • Number of events 1 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/126 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/45 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.79%
1/126 • Number of events 1 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Infections and infestations
Sepsis
|
0.00%
0/45 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
1.6%
2/126 • Number of events 3 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Infections and infestations
Septic shock
|
0.00%
0/45 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.79%
1/126 • Number of events 1 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Infections and infestations
Urinary tract infection
|
2.2%
1/45 • Number of events 1 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
2.4%
3/126 • Number of events 4 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/45 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.79%
1/126 • Number of events 1 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
2.2%
1/45 • Number of events 1 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
1.6%
2/126 • Number of events 2 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/45 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.79%
1/126 • Number of events 1 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/45 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.79%
1/126 • Number of events 1 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/45 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
1.6%
2/126 • Number of events 2 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Investigations
C-reactive protein increased
|
2.2%
1/45 • Number of events 1 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/126 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/45 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.79%
1/126 • Number of events 1 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Investigations
Lipase increased
|
0.00%
0/45 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.79%
1/126 • Number of events 1 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Investigations
Platelet count decreased
|
0.00%
0/45 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.79%
1/126 • Number of events 1 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/45 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.79%
1/126 • Number of events 1 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.00%
0/45 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.79%
1/126 • Number of events 1 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/45 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.79%
1/126 • Number of events 1 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/45 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.79%
1/126 • Number of events 1 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.2%
1/45 • Number of events 1 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/126 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/45 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.79%
1/126 • Number of events 1 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.2%
1/45 • Number of events 1 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/126 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/45 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.79%
1/126 • Number of events 1 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/45 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.79%
1/126 • Number of events 3 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/45 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
1.6%
2/126 • Number of events 2 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Product Issues
Device occlusion
|
0.00%
0/45 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
3.2%
4/126 • Number of events 4 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/45 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.79%
1/126 • Number of events 1 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/45 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.79%
1/126 • Number of events 1 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/45 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
2.4%
3/126 • Number of events 3 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/45 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.79%
1/126 • Number of events 1 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Renal and urinary disorders
Pyelocaliectasis
|
0.00%
0/45 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.79%
1/126 • Number of events 1 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/45 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.79%
1/126 • Number of events 1 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/45 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
1.6%
2/126 • Number of events 2 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Reproductive system and breast disorders
Female genital tract fistula
|
0.00%
0/45 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
1.6%
2/126 • Number of events 2 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
4.4%
2/45 • Number of events 2 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.79%
1/126 • Number of events 1 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/45 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.79%
1/126 • Number of events 1 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/45 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.79%
1/126 • Number of events 1 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
2.2%
1/45 • Number of events 1 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/126 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/45 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.79%
1/126 • Number of events 1 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Vascular disorders
Embolism
|
0.00%
0/45 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.79%
1/126 • Number of events 1 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/45 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.79%
1/126 • Number of events 1 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Vascular disorders
Hypotension
|
0.00%
0/45 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.79%
1/126 • Number of events 1 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Vascular disorders
Raynaud's phenomenon
|
0.00%
0/45 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.79%
1/126 • Number of events 1 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
Other adverse events
| Measure |
Atezolizumab
n=45 participants at risk
Participants received atezolizumab monotherapy until disease progression, loss of clinical benefit, or unacceptable toxicity as determined by the investigator.
|
Tiragolumab Plus Atezolizumab
n=126 participants at risk
Participants received tiragolumab and atezolizumab until disease progression, loss of clinical benefit, or unacceptable toxicity as determined by the investigator.
|
Post Crossover Tiragolumab Plus Atezolizumab
n=13 participants at risk
After unequivocal progressive disease had been recorded during atezolizumab monotherapy, crossover was allowed from the atezolizumab monotherapy arm to the tiragolumab plus atezolizumab arm at the discretion of the investigator and after consultation with the Medical Monitor.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
20.0%
9/45 • Number of events 20 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
31.0%
39/126 • Number of events 86 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
7.7%
1/13 • Number of events 2 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
4.4%
2/45 • Number of events 4 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
4.0%
5/126 • Number of events 14 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
7.7%
1/13 • Number of events 2 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Endocrine disorders
Hyperthyroidism
|
4.4%
2/45 • Number of events 4 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
5.6%
7/126 • Number of events 14 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Endocrine disorders
Hypothyroidism
|
4.4%
2/45 • Number of events 6 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
5.6%
7/126 • Number of events 14 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
7.7%
1/13 • Number of events 2 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.2%
1/45 • Number of events 2 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
13.5%
17/126 • Number of events 40 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
23.1%
3/13 • Number of events 6 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.7%
3/45 • Number of events 6 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
3.2%
4/126 • Number of events 8 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Gastrointestinal disorders
Constipation
|
8.9%
4/45 • Number of events 10 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
10.3%
13/126 • Number of events 36 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.7%
3/45 • Number of events 6 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
13.5%
17/126 • Number of events 48 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
15.4%
2/13 • Number of events 4 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Gastrointestinal disorders
Nausea
|
11.1%
5/45 • Number of events 10 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
19.8%
25/126 • Number of events 60 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
15.4%
2/13 • Number of events 4 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Gastrointestinal disorders
Vomiting
|
15.6%
7/45 • Number of events 14 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
14.3%
18/126 • Number of events 46 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
7.7%
1/13 • Number of events 2 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
General disorders
Asthenia
|
13.3%
6/45 • Number of events 12 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
17.5%
22/126 • Number of events 52 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
7.7%
1/13 • Number of events 2 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
General disorders
Chills
|
4.4%
2/45 • Number of events 4 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
3.2%
4/126 • Number of events 10 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
7.7%
1/13 • Number of events 2 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
General disorders
Face oedema
|
0.00%
0/45 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/126 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
7.7%
1/13 • Number of events 2 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
General disorders
Fatigue
|
6.7%
3/45 • Number of events 6 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
17.5%
22/126 • Number of events 58 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
7.7%
1/13 • Number of events 2 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
General disorders
Oedema peripheral
|
6.7%
3/45 • Number of events 8 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
7.9%
10/126 • Number of events 22 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
7.7%
1/13 • Number of events 2 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
General disorders
Pyrexia
|
13.3%
6/45 • Number of events 18 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
15.9%
20/126 • Number of events 46 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/45 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.79%
1/126 • Number of events 2 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
7.7%
1/13 • Number of events 2 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Infections and infestations
Urinary tract infection
|
4.4%
2/45 • Number of events 4 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
12.7%
16/126 • Number of events 48 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
8.9%
4/45 • Number of events 10 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
7.9%
10/126 • Number of events 22 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
7.7%
1/13 • Number of events 2 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Investigations
Alanine aminotransferase increased
|
6.7%
3/45 • Number of events 8 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
6.3%
8/126 • Number of events 16 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
7.7%
1/13 • Number of events 2 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Investigations
Aspartate aminotransferase increased
|
4.4%
2/45 • Number of events 4 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
7.1%
9/126 • Number of events 20 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/45 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
6.3%
8/126 • Number of events 16 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
15.4%
2/13 • Number of events 4 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/45 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/126 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
7.7%
1/13 • Number of events 2 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Investigations
Blood creatinine increased
|
6.7%
3/45 • Number of events 6 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
4.0%
5/126 • Number of events 12 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
7.7%
1/13 • Number of events 2 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/45 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
1.6%
2/126 • Number of events 4 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
15.4%
2/13 • Number of events 4 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Investigations
Blood magnesium increased
|
0.00%
0/45 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/126 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
7.7%
1/13 • Number of events 2 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Investigations
Blood sodium decreased
|
0.00%
0/45 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.79%
1/126 • Number of events 2 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
7.7%
1/13 • Number of events 2 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Investigations
Gamma-glutamyltransferase increased
|
2.2%
1/45 • Number of events 2 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.79%
1/126 • Number of events 2 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
7.7%
1/13 • Number of events 2 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Investigations
Weight decreased
|
2.2%
1/45 • Number of events 2 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
7.1%
9/126 • Number of events 18 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
7.7%
1/13 • Number of events 2 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.7%
3/45 • Number of events 6 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
14.3%
18/126 • Number of events 38 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
7.7%
1/13 • Number of events 2 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/45 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/126 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
7.7%
1/13 • Number of events 2 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/45 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
7.9%
10/126 • Number of events 22 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
15.6%
7/45 • Number of events 14 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
11.9%
15/126 • Number of events 42 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.4%
2/45 • Number of events 4 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
7.9%
10/126 • Number of events 24 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
7.7%
1/13 • Number of events 2 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.7%
3/45 • Number of events 6 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
4.0%
5/126 • Number of events 10 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/45 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
4.8%
6/126 • Number of events 14 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
7.7%
1/13 • Number of events 2 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Nervous system disorders
Headache
|
4.4%
2/45 • Number of events 4 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
9.5%
12/126 • Number of events 32 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/45 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
6.3%
8/126 • Number of events 16 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Psychiatric disorders
Insomnia
|
4.4%
2/45 • Number of events 4 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
5.6%
7/126 • Number of events 14 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Renal and urinary disorders
Dysuria
|
2.2%
1/45 • Number of events 2 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
5.6%
7/126 • Number of events 16 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/45 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
6.3%
8/126 • Number of events 16 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.1%
5/45 • Number of events 10 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
4.0%
5/126 • Number of events 12 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.2%
1/45 • Number of events 2 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.79%
1/126 • Number of events 2 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
7.7%
1/13 • Number of events 2 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/45 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.79%
1/126 • Number of events 2 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
7.7%
1/13 • Number of events 2 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/45 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
18.3%
23/126 • Number of events 60 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.2%
1/45 • Number of events 2 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
8.7%
11/126 • Number of events 22 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/13 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
|
Vascular disorders
Superficial vein thrombosis
|
0.00%
0/45 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
0.00%
0/126 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
7.7%
1/13 • Number of events 2 • From initiation of study treatment up to 90 days after last dose (approximately 17 months) Data collection is ongoing, the Adverse Events section will be updated one year after study completion date.
Treated Population=all randomized participants that received at least one dose of study treatment. Participants are grouped according to the actual treatment received. Participants crossing over from atezolizumab to tiragolumab plus atezolizumab arm are represented separately post crossover. All AEs: reported until 30 days after the last study dose/start of new systemic anti-cancer therapy. SAEs \& AEs of special interest: reported up to 90 days after last study dose.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER