Trial Outcomes & Findings for Study of Atezolizumab as Monotherapy and in Combination With Platinum-Based Chemotherapy in Participants With Untreated Locally Advanced or Metastatic Urothelial Carcinoma (NCT NCT02807636)
NCT ID: NCT02807636
Last Updated: 2025-02-24
Results Overview
PFS is defined as the time from randomization to the first documented disease progression as determined by the investigator with the use of RECIST v1.1, or death from any cause, whichever occurs first.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1213 participants
Primary outcome timeframe
Baseline up to first documented disease progression or death, whichever occurs first (up to approximately 35 months)
Results posted on
2025-02-24
Participant Flow
Participants were enrolled in 221 sites in 35 countries.
Stage 1 included atezolizumab+gemcitabine+carboplatin arm or placebo+gemcitabine+carboplatin arm. Participants ineligible for cisplatin-based chemo were enrolled in this stage. Stage 2 included addition of atezolizumab monotherapy arm and allowed participants who were eligible for cisplatin-based chemotherapy. Study is considered "Completed" because all pre-planned study analyses have been preformed for primary and secondary endpoints.
Participant milestones
| Measure |
Placebo+Gemcitabine+Carboplatin/Cisplatin
Participants received blinded placebo matched to atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
|
Atezolizumab+Gemcitabine+Carboplatin/Cisplatin
Participants received blinded atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
|
Atezolizumab Monotherapy
Eligible participants received open-label atezolizumab as monotherapy.
|
|---|---|---|---|
|
Overall Study
STARTED
|
400
|
451
|
362
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
400
|
451
|
362
|
Reasons for withdrawal
| Measure |
Placebo+Gemcitabine+Carboplatin/Cisplatin
Participants received blinded placebo matched to atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
|
Atezolizumab+Gemcitabine+Carboplatin/Cisplatin
Participants received blinded atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
|
Atezolizumab Monotherapy
Eligible participants received open-label atezolizumab as monotherapy.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
10
|
13
|
6
|
|
Overall Study
Protocol Deviation
|
1
|
0
|
0
|
|
Overall Study
Symptomatic Deterioration
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
39
|
28
|
24
|
|
Overall Study
Death
|
303
|
332
|
272
|
|
Overall Study
Study Terminated By Sponsor
|
47
|
76
|
60
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
Baseline Characteristics
Study of Atezolizumab as Monotherapy and in Combination With Platinum-Based Chemotherapy in Participants With Untreated Locally Advanced or Metastatic Urothelial Carcinoma
Baseline characteristics by cohort
| Measure |
Placebo+Gemcitabine+Carboplatin/Cisplatin
n=400 Participants
Participants received blinded placebo matched to atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
|
Atezolizumab+Gemcitabine+Carboplatin/Cisplatin
n=451 Participants
Participants received blinded atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
|
Atezolizumab Monotherapy
n=362 Participants
Eligible participants received open-label atezolizumab as monotherapy.
|
Total
n=1213 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
66.4 Years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
67.5 Years
STANDARD_DEVIATION 9.7 • n=7 Participants
|
67.0 Years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
67.0 Years
STANDARD_DEVIATION 9.4 • n=4 Participants
|
|
Sex: Female, Male
Female
|
102 Participants
n=5 Participants
|
113 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
297 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
298 Participants
n=5 Participants
|
338 Participants
n=7 Participants
|
280 Participants
n=5 Participants
|
916 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
44 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
125 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
350 Participants
n=5 Participants
|
402 Participants
n=7 Participants
|
311 Participants
n=5 Participants
|
1063 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
85 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
269 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
305 Participants
n=5 Participants
|
346 Participants
n=7 Participants
|
260 Participants
n=5 Participants
|
911 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline up to first documented disease progression or death, whichever occurs first (up to approximately 35 months)Population: The ITT population was defined as all participants randomized to the Atezolizumab+Gemcitabine+Carboplatin/Cisplatin arm or the Placebo+Gemcitabine+Carboplatin/Cisplatin arm in Stages 1 and 2, whether or not the assigned study treatment was received.
PFS is defined as the time from randomization to the first documented disease progression as determined by the investigator with the use of RECIST v1.1, or death from any cause, whichever occurs first.
Outcome measures
| Measure |
Placebo+Gemcitabine+Carboplatin/Cisplatin
n=400 Participants
Participants received blinded placebo matched to atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
|
Atezolizumab+Gemcitabine+Carboplatin/Cisplatin
n=451 Participants
Participants received blinded atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
|
Atezolizumab Monotherapy
Eligible participants received open-label atezolizumab as monotherapy.
|
|---|---|---|---|
|
Investigator Assessed Progression-Free Survival (PFS) in the Placebo+Gemcitabine+Carboplatin/Cisplatin Arm Versus Atezolizumab +Gemcitabine+Carboplatin/Cisplatin Arm
|
6.34 Months
Interval 6.24 to 7.0
|
8.18 Months
Interval 6.51 to 8.34
|
—
|
PRIMARY outcome
Timeframe: Baseline until death due to any cause (up to approximately 73 months)Population: The ITT population was defined as all participants randomized to the Atezolizumab+Gemcitabine+Carboplatin/Cisplatin arm or the Placebo+Gemcitabine+Carboplatin/Cisplatin arm in Stages 1 and 2, whether or not the assigned study treatment was received.
OS is defined as the time from randomization to death due to any cause.
Outcome measures
| Measure |
Placebo+Gemcitabine+Carboplatin/Cisplatin
n=400 Participants
Participants received blinded placebo matched to atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
|
Atezolizumab+Gemcitabine+Carboplatin/Cisplatin
n=451 Participants
Participants received blinded atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
|
Atezolizumab Monotherapy
Eligible participants received open-label atezolizumab as monotherapy.
|
|---|---|---|---|
|
Overall Survival (OS) in Atezolizumab+Gemcitabine+Carboplatin/Cisplatin Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm
|
13.44 Months
Interval 11.99 to 15.34
|
16.13 Months
Interval 14.19 to 18.76
|
—
|
PRIMARY outcome
Timeframe: Baseline until death due to any cause (up to approximately 73 months)Population: The ITT population includes only participants concurrently enrolled in Stage 2 and only those who had been randomized at the time of approval of Protocol WO30070 v6.
OS is defined as the time from randomization to death due to any cause.
Outcome measures
| Measure |
Placebo+Gemcitabine+Carboplatin/Cisplatin
n=359 Participants
Participants received blinded placebo matched to atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
|
Atezolizumab+Gemcitabine+Carboplatin/Cisplatin
n=360 Participants
Participants received blinded atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
|
Atezolizumab Monotherapy
Eligible participants received open-label atezolizumab as monotherapy.
|
|---|---|---|---|
|
Overall Survival (OS) in Atezolizumab Monotherapy Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm
|
13.34 Months
Interval 11.89 to 15.61
|
15.21 Months
Interval 13.14 to 17.68
|
—
|
SECONDARY outcome
Timeframe: Baseline up to disease progression, death, or loss of follow-up, whichever occurs first (up to approximately 73 months)Population: The ITT population was defined as all participants randomized to the Atezolizumab+Gemcitabine+Carboplatin/Cisplatin arm or the Placebo+Gemcitabine+Carboplatin/Cisplatin arm in Stages 1 and 2, whether or not the assigned study treatment was received. The measurable disease populations were defined as participants in the respective ITT populations with at least one measurable lesion according to RECIST v1.1 based on investigator assessment.
Objective response rate (ORR) is defined as the proportion of participants with a confirmed objective response, either complete response (CR) or partial response (PR), observed on two assessments \>= 28 days apart per RECIST v1.1, based on investigator assessment. The analysis population for ORR will be all randomized participants with measurable disease at baseline.
Outcome measures
| Measure |
Placebo+Gemcitabine+Carboplatin/Cisplatin
n=397 Participants
Participants received blinded placebo matched to atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
|
Atezolizumab+Gemcitabine+Carboplatin/Cisplatin
n=447 Participants
Participants received blinded atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
|
Atezolizumab Monotherapy
Eligible participants received open-label atezolizumab as monotherapy.
|
|---|---|---|---|
|
Objective Response Rate (ORR) in Atezolizumab+Gemcitabine+Carboplatin/Cisplatin Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm
|
44.8 Percentage of Participants
Interval 39.87 to 49.88
|
48.1 Percentage of Participants
Interval 43.38 to 52.84
|
—
|
SECONDARY outcome
Timeframe: Baseline up to disease progression, death, or loss of follow-up, whichever occurs first (up to approximately 73 months)Population: The ITT population includes only participants concurrently enrolled in Stage 2 and only those who had been randomized at the time of approval of Protocol WO30070 v6. The measurable disease populations were defined as participants in the respective ITT populations with at least one measurable lesion according to RECIST v1.1 based on investigator assessment.
Objective response rate (ORR) is defined as the proportion of participants with a confirmed objective response, either complete response (CR) or partial response (PR), observed on two assessments \>= 28 days apart per RECIST v1.1, based on investigator assessment. The analysis population for ORR will be all randomized participants with measurable disease at baseline.
Outcome measures
| Measure |
Placebo+Gemcitabine+Carboplatin/Cisplatin
n=356 Participants
Participants received blinded placebo matched to atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
|
Atezolizumab+Gemcitabine+Carboplatin/Cisplatin
n=359 Participants
Participants received blinded atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
|
Atezolizumab Monotherapy
Eligible participants received open-label atezolizumab as monotherapy.
|
|---|---|---|---|
|
Objective Response Rate (ORR) in Atezolizumab Monotherapy Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm
|
44.4 Percentage of Participants
Interval 39.15 to 49.71
|
24.2 Percentage of Participants
Interval 19.89 to 29.01
|
—
|
SECONDARY outcome
Timeframe: From first documented objective response (CR or PR) to disease progression, death, or loss of follow-up, whichever occurs first (up to approximately 73 months)Population: The duration of response (DOR)-evaluable population is defined as participants with an objective response in the Atezolizumab+Gemcitabine+Carboplatin/Cisplatin arm or the Placebo+Gemcitabine+Carboplatin/Cisplatin arm in Stages 1 and 2.
Duration of response (DOR) is defined for participants with an objective response as the time from the first documented objective response to documented disease progression per RECIST v1.1, based on investigator assessment, or death due to any cause, whichever occurs first.
Outcome measures
| Measure |
Placebo+Gemcitabine+Carboplatin/Cisplatin
n=178 Participants
Participants received blinded placebo matched to atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
|
Atezolizumab+Gemcitabine+Carboplatin/Cisplatin
n=215 Participants
Participants received blinded atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
|
Atezolizumab Monotherapy
Eligible participants received open-label atezolizumab as monotherapy.
|
|---|---|---|---|
|
Duration of Response (DOR) in Atezolizumab+Gemcitabine+Carboplatin/Cisplatin Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm
|
8.15 Months
Interval 6.34 to 8.61
|
9.13 Months
Interval 8.02 to 10.64
|
—
|
SECONDARY outcome
Timeframe: From first documented objective response (CR or PR) to disease progression, death, or loss of follow-up, whichever occurs first (up to approximately 73 months)Population: The duration of response (DOR)-evaluable population is defined as participants with an objective response in the the ITT population which included only participants concurrently enrolled in Stage 2 and only those who had been randomized at the time of approval of Protocol WO30070 v6.
Duration of response (DOR) is defined for participants with an objective response as the time from the first documented objective response to documented disease progression per RECIST v1.1, based on investigator assessment, or death due to any cause, whichever occurs first.
Outcome measures
| Measure |
Placebo+Gemcitabine+Carboplatin/Cisplatin
n=158 Participants
Participants received blinded placebo matched to atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
|
Atezolizumab+Gemcitabine+Carboplatin/Cisplatin
n=87 Participants
Participants received blinded atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
|
Atezolizumab Monotherapy
Eligible participants received open-label atezolizumab as monotherapy.
|
|---|---|---|---|
|
Duration of Response (DOR) in Atezolizumab Monotherapy Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm
|
8.11 Months
Interval 6.28 to 8.54
|
29.63 Months
Interval 15.9 to
Upper CI limit is not evaluable because there were not enough events at later time to get a reliable upper CI.
|
—
|
SECONDARY outcome
Timeframe: Randomization to first documented disease progression or death from any cause (up to 35 months)Population: The ITT population was defined as all participants randomized to the Atezolizumab+Gemcitabine+Carboplatin/Cisplatin arm or the Placebo+Gemcitabine+Carboplatin/Cisplatin arm in Stages 1 and 2, whether or not the assigned study treatment was received.
Independent review facility PFS (IRF-PFS) is defined as the time from randomization to the first documented disease progression as determined by blinded independent central review with use of RECIST v1.1, or death due to any cause, whichever occurs first.
Outcome measures
| Measure |
Placebo+Gemcitabine+Carboplatin/Cisplatin
n=400 Participants
Participants received blinded placebo matched to atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
|
Atezolizumab+Gemcitabine+Carboplatin/Cisplatin
n=451 Participants
Participants received blinded atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
|
Atezolizumab Monotherapy
Eligible participants received open-label atezolizumab as monotherapy.
|
|---|---|---|---|
|
IRF-PFS
|
6.34 Months
Interval 6.24 to 8.05
|
7.10 Months
Interval 6.31 to 8.25
|
—
|
SECONDARY outcome
Timeframe: Year 1Population: The ITT population was defined as all participants randomized to the Atezolizumab+Gemcitabine+Carboplatin/Cisplatin or the Placebo+Gemcitabine+Carboplatin/Cisplatin arm in Stages 1 and 2, whether or not the assigned study treatment was received.
Overall Survival (OS) Event Free Rate at 1 Year.
Outcome measures
| Measure |
Placebo+Gemcitabine+Carboplatin/Cisplatin
n=400 Participants
Participants received blinded placebo matched to atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
|
Atezolizumab+Gemcitabine+Carboplatin/Cisplatin
n=451 Participants
Participants received blinded atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
|
Atezolizumab Monotherapy
Eligible participants received open-label atezolizumab as monotherapy.
|
|---|---|---|---|
|
OS Event Free Rate Atezolizumab+Gemcitabine+Carboplatin/Cisplatin Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm
|
55.00 Percentage
Interval 49.98 to 60.02
|
60.00 Percentage
Interval 55.39 to 64.61
|
—
|
SECONDARY outcome
Timeframe: Year 1Population: The ITT population includes only participants concurrently enrolled in Stage 2 and only those who had been randomized at the time of approval of Protocol WO30070 v6.
Overall Survival (OS) Event Free Rate at 1 Year.
Outcome measures
| Measure |
Placebo+Gemcitabine+Carboplatin/Cisplatin
n=359 Participants
Participants received blinded placebo matched to atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
|
Atezolizumab+Gemcitabine+Carboplatin/Cisplatin
n=360 Participants
Participants received blinded atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
|
Atezolizumab Monotherapy
Eligible participants received open-label atezolizumab as monotherapy.
|
|---|---|---|---|
|
OS Event Free Rate in Atezolizumab Monotherapy Arm Versus Placebo+Gemcitabine+Carboplatin/Cisplatin Arm
|
54.56 Percentage
Interval 49.23 to 59.88
|
57.91 Percentage
Interval 52.72 to 63.1
|
—
|
SECONDARY outcome
Timeframe: Year 1Population: The ITT population was defined as all participants randomized to the Atezolizumab+Gemcitabine+Carboplatin/Cisplatin arm or the Placebo+Gemcitabine+Carboplatin/Cisplatin arm in Stages 1 and 2, whether or not the assigned study treatment was received.
Progression Free Survival (PFS) Event Free Rate at Year 1
Outcome measures
| Measure |
Placebo+Gemcitabine+Carboplatin/Cisplatin
n=400 Participants
Participants received blinded placebo matched to atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
|
Atezolizumab+Gemcitabine+Carboplatin/Cisplatin
n=451 Participants
Participants received blinded atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
|
Atezolizumab Monotherapy
Eligible participants received open-label atezolizumab as monotherapy.
|
|---|---|---|---|
|
PFS Event Free Rate
|
22.17 Percentage
Interval 17.93 to 26.42
|
30.47 Percentage
Interval 26.0 to 34.93
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 73 monthsPopulation: The patient reported outcome (PRO)-evaluable population is defined as participants in the ITT populations for comparisons of the Placebo+Chemo Arm versus Atezolizumab+Chemo Arm who have a baseline and at least one post-baseline assessment. The ITT population for the comparison of Atezo+Chemo Arm vs. Placebo+Chemo Arm included participants enrolled in Stage 1 and Stage 2, which consisted of 451 paarticipants in the Atezo+Chemo Arm and 400 participants in the Placebo+Chemo Arm.
Time to deterioration in global health status as measured by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 in the Placebo+Gemcitabine+Carboplatin/Cisplatin Arm versus Atezolizumab +Gemcitabine+Carboplatin/Cisplatin Arm.
Outcome measures
| Measure |
Placebo+Gemcitabine+Carboplatin/Cisplatin
n=400 Participants
Participants received blinded placebo matched to atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
|
Atezolizumab+Gemcitabine+Carboplatin/Cisplatin
n=451 Participants
Participants received blinded atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
|
Atezolizumab Monotherapy
Eligible participants received open-label atezolizumab as monotherapy.
|
|---|---|---|---|
|
Time to Deterioration in Global Health Status as Measured by the EORTC QLQ-C30 Score in the Placebo+Gemcitabine+Carboplatin/Cisplatin Arm Versus Atezolizumab +Gemcitabine+Carboplatin/Cisplatin Arm
|
12.06 Months
Interval 8.28 to 20.24
|
32.07 Months
Interval 18.4 to
Not evaluable due to sample size is very small and not enough events at later times to estimate the upper bound of the CI.
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 73 monthsPopulation: Evaluable population defined as patients in ITT for comparisons of Placebo+Chemo vs. Atezo Mono who have a baseline and at least one post-baseline assessment. ITT for comparison of Atezo Mono vs. Placebo+Chemo consisted of 360 patients enrolled in Atezo Mono in Stage 2. Although a total of 400 patients were randomized to Placebo+Chemo throughout study, only 359 patients who were concurrently enrolled into this arm in Stage 2 and prior to Protocol v6 were included in Placebo+Chemo of this ITT.
Time to deterioration in global health status as measured by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 in the Placebo+Chemo Arm versus Atezolizumab Monotherapy Arm.
Outcome measures
| Measure |
Placebo+Gemcitabine+Carboplatin/Cisplatin
n=359 Participants
Participants received blinded placebo matched to atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
|
Atezolizumab+Gemcitabine+Carboplatin/Cisplatin
n=360 Participants
Participants received blinded atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
|
Atezolizumab Monotherapy
Eligible participants received open-label atezolizumab as monotherapy.
|
|---|---|---|---|
|
Time to Deterioration in Global Health Status as Measured by the EORTC QLQ-C30 Score in the Placebo+Gemcitabine+Carboplatin/Cisplatin Arm Versus Atezolizumab Monotherapy Arm
|
12.02 Months
Interval 8.08 to 20.24
|
23.20 Months
Interval 8.31 to
Not evaluable due to sample size is very small and not enough events at later times to estimate the upper bound of the CI.
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 73 monthsPopulation: The patient reported outcome (PRO)-evaluable population is defined as participants in the ITT populations for comparisons of the Placebo+Chemo Arm versus Atezolizumab+Chemo Arm who have a baseline and at least one post-baseline assessment. The ITT population for the comparison of Atezo+Chemo Arm vs. Placebo+Chemo Arm included participants enrolled in Stage 1 and Stage 2, which consisted of 451 paarticipants in the Atezo+Chemo Arm and 400 participants in the Placebo+Chemo Arm.
Median time to deterioration in physical function as measured by the QLQ-C30 in the Placebo+Gemcitabine+Carboplatin/Cisplatin Arm versus Atezolizumab +Gemcitabine+Carboplatin/Cisplatin Arm.
Outcome measures
| Measure |
Placebo+Gemcitabine+Carboplatin/Cisplatin
n=400 Participants
Participants received blinded placebo matched to atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
|
Atezolizumab+Gemcitabine+Carboplatin/Cisplatin
n=451 Participants
Participants received blinded atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
|
Atezolizumab Monotherapy
Eligible participants received open-label atezolizumab as monotherapy.
|
|---|---|---|---|
|
Time to Deterioration in Physical Function as Measured by the EORTC QLQ-C30 Score in the Placebo+Gemcitabine+Carboplatin/Cisplatin Arm Versus Atezolizumab +Gemcitabine+Carboplatin/Cisplatin Arm
|
15.74 Months
Interval 8.28 to 22.57
|
16.39 Months
Interval 9.07 to 26.68
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 73 monthsPopulation: Evaluable population defined as patients in ITT for comparisons of Placebo+Chemo vs. Atezo Mono who have a baseline and at least one post-baseline assessment. ITT for comparison of Atezo Mono vs. Placebo+Chemo consisted of 360 patients enrolled in Atezo Mono in Stage 2. Although a total of 400 patients were randomized to Placebo+Chemo throughout study, only 359 patients who were concurrently enrolled into this arm in Stage 2 and prior to Protocol v6 were included in Placebo+Chemo of this ITT.
Median time to deterioration in physical function as measured by the QLQ-C30 in the Placebo+Gemcitabine+Carboplatin/Cisplatin Arm versus Atezolizumab Monotherapy Arm.
Outcome measures
| Measure |
Placebo+Gemcitabine+Carboplatin/Cisplatin
n=359 Participants
Participants received blinded placebo matched to atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
|
Atezolizumab+Gemcitabine+Carboplatin/Cisplatin
n=360 Participants
Participants received blinded atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
|
Atezolizumab Monotherapy
Eligible participants received open-label atezolizumab as monotherapy.
|
|---|---|---|---|
|
Time to Deterioration in Physical Function as Measured by the EORTC QLQ-C30 Score in the Placebo+Gemcitabine+Carboplatin/Cisplatin Arm Versus Atezolizumab Monotherapy Arm
|
16.10 Months
Interval 8.08 to 22.57
|
9.23 Months
Interval 6.24 to 17.48
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1Population: The pharmacokinetic (PK)-evaluable population is defined as all participants dosed with atezolizumab who have at least one post-baseline PK result.
Maximum atezolizumab serum concentration.
Outcome measures
| Measure |
Placebo+Gemcitabine+Carboplatin/Cisplatin
n=394 Participants
Participants received blinded placebo matched to atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
|
Atezolizumab+Gemcitabine+Carboplatin/Cisplatin
n=309 Participants
Participants received blinded atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
|
Atezolizumab Monotherapy
Eligible participants received open-label atezolizumab as monotherapy.
|
|---|---|---|---|
|
Maximum Atezolizumab Serum Concentration
|
379 μg/ mL
Standard Deviation 125
|
390 μg/ mL
Standard Deviation 129
|
—
|
SECONDARY outcome
Timeframe: Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 8 Day 1, Cycle 16 Day 1, Cycle 24 Day 1, Cycle 32 Day 1, Day 120 post dose of last blinded atezolizumab treatment, and study drug early discontinuationPopulation: The pharmacokinetic (PK)-evaluable population is defined as all participants dosed with atezolizumab who have at least one post-baseline PK result.
Minimum atezolizumab serum concentration.
Outcome measures
| Measure |
Placebo+Gemcitabine+Carboplatin/Cisplatin
n=382 Participants
Participants received blinded placebo matched to atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
|
Atezolizumab+Gemcitabine+Carboplatin/Cisplatin
n=297 Participants
Participants received blinded atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
|
Atezolizumab Monotherapy
Eligible participants received open-label atezolizumab as monotherapy.
|
|---|---|---|---|
|
Minimum Atezolizumab Serum Concentration
Cycle 3 Day 1
|
122 μg/ mL
Standard Deviation 47.2
|
129 μg/ mL
Standard Deviation 66.0
|
—
|
|
Minimum Atezolizumab Serum Concentration
Cycle 2 Day 1
|
79.8 μg/ mL
Standard Deviation 52.5
|
80.2 μg/ mL
Standard Deviation 46.0
|
—
|
|
Minimum Atezolizumab Serum Concentration
Cycle 4 Day 1
|
153 μg/ mL
Standard Deviation 70.4
|
157 μg/ mL
Standard Deviation 63.4
|
—
|
|
Minimum Atezolizumab Serum Concentration
Cycle 8 Day 1
|
216 μg/ mL
Standard Deviation 96.8
|
193 μg/ mL
Standard Deviation 79.8
|
—
|
|
Minimum Atezolizumab Serum Concentration
Cycle 16 Day 1
|
235 μg/ mL
Standard Deviation 103
|
220 μg/ mL
Standard Deviation 79.8
|
—
|
|
Minimum Atezolizumab Serum Concentration
Cycle 24 Day 1
|
244 μg/ mL
Standard Deviation 75.7
|
233 μg/ mL
Standard Deviation 92.5
|
—
|
|
Minimum Atezolizumab Serum Concentration
Cycle 32 Day 1
|
259 μg/ mL
Standard Deviation 97.2
|
258 μg/ mL
Standard Deviation 60.5
|
—
|
|
Minimum Atezolizumab Serum Concentration
Day 120 Post Dose of Last Blinded Atezo Trt
|
18.8 μg/ mL
Standard Deviation 36.9
|
9.53 μg/ mL
Standard Deviation 12.7
|
—
|
|
Minimum Atezolizumab Serum Concentration
Study Drug Early Discontinuation
|
154 μg/ mL
Standard Deviation 102
|
124 μg/ mL
Standard Deviation 83.8
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 35 monthsPopulation: The baseline ADA-evaluable population included participants who had a baseline ADA result. The post-baseline ADA-evaluable population included participants who had received at least one dose of the study treatment and who had at least one post-baseline ADA result.
Percentage of participants with Anti-Therapeutic (Anti-Atezolizumab) Antibodies (ATAs).
Outcome measures
| Measure |
Placebo+Gemcitabine+Carboplatin/Cisplatin
n=434 Participants
Participants received blinded placebo matched to atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
|
Atezolizumab+Gemcitabine+Carboplatin/Cisplatin
n=341 Participants
Participants received blinded atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
|
Atezolizumab Monotherapy
Eligible participants received open-label atezolizumab as monotherapy.
|
|---|---|---|---|
|
Percentage of Participants With Anti-Therapeutic (Anti-Atezolizumab) Antibodies (ATAs)
Baseline evaluable participants
|
1.2 Percentage of participants
|
0.9 Percentage of participants
|
—
|
|
Percentage of Participants With Anti-Therapeutic (Anti-Atezolizumab) Antibodies (ATAs)
Post-baseline evaluable participants
|
19.7 Percentage of participants
|
26.3 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline up to disease progression, death, or loss of follow-up, whichever occurs first (assessed at baseline, every 9 weeks for 54 weeks and every 12 weeks thereafter up to 35 months)Population: The ITT population includes only participants concurrently enrolled in Stage 2 and only those who had been randomized at the time of approval of Protocol WO30070 v6.
PFS is defined as the time from randomization to the first documented disease progression as determined by the investigator with the use of RECIST v1.1, or death from any cause, whichever occurs first.
Outcome measures
| Measure |
Placebo+Gemcitabine+Carboplatin/Cisplatin
n=359 Participants
Participants received blinded placebo matched to atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
|
Atezolizumab+Gemcitabine+Carboplatin/Cisplatin
n=360 Participants
Participants received blinded atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
|
Atezolizumab Monotherapy
Eligible participants received open-label atezolizumab as monotherapy.
|
|---|---|---|---|
|
Investigator-Assessed Progression-Free Survival (INV-PFS) in Participants Treated With Atezolizumab Monotherapy Arm Compared With Placebo+Gemcitabine+Carboplatin/Cisplatin Arm
|
6.31 Months
Interval 6.24 to 6.74
|
2.69 Months
Interval 2.2 to 4.04
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 93 monthsPopulation: The safety population was defined as participants who received any amount of any component of study treatment. Participants were analyzed according to the treatment received.
Percentage of participants with Grade 3-4 Adverse Events (AEs) assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
Outcome measures
| Measure |
Placebo+Gemcitabine+Carboplatin/Cisplatin
n=454 Participants
Participants received blinded placebo matched to atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
|
Atezolizumab+Gemcitabine+Carboplatin/Cisplatin
n=389 Participants
Participants received blinded atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
|
Atezolizumab Monotherapy
n=354 Participants
Eligible participants received open-label atezolizumab as monotherapy.
|
|---|---|---|---|
|
Percentage of Participants With Grade 3-4 Adverse Events (AEs)
|
84.1 Percentage of Participants
|
84.6 Percentage of Participants
|
46.3 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline up to 93 monthsPopulation: The safety population was defined as participants who received any amount of any component of study treatment. Participants were analyzed according to the treatment received.
Percentage of participants with Grade 5 Adverse Events (AEs) assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
Outcome measures
| Measure |
Placebo+Gemcitabine+Carboplatin/Cisplatin
n=454 Participants
Participants received blinded placebo matched to atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
|
Atezolizumab+Gemcitabine+Carboplatin/Cisplatin
n=389 Participants
Participants received blinded atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
|
Atezolizumab Monotherapy
n=354 Participants
Eligible participants received open-label atezolizumab as monotherapy.
|
|---|---|---|---|
|
Percentage of Participants With Grade 5 Adverse Events (AEs)
|
7.5 Percentage of Participants
|
5.7 Percentage of Participants
|
7.9 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline up to 93 monthsPopulation: The safety population was defined as participants who received any amount of any component of study treatment. Participants were analyzed according to the treatment received.
Percentage of participants with Serious Adverse Events (SAEs) assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
Outcome measures
| Measure |
Placebo+Gemcitabine+Carboplatin/Cisplatin
n=454 Participants
Participants received blinded placebo matched to atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
|
Atezolizumab+Gemcitabine+Carboplatin/Cisplatin
n=389 Participants
Participants received blinded atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
|
Atezolizumab Monotherapy
n=354 Participants
Eligible participants received open-label atezolizumab as monotherapy.
|
|---|---|---|---|
|
Percentage of Participants With Serious Adverse Events (SAEs)
|
53.7 Percentage of Participants
|
50.6 Percentage of Participants
|
46.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline up to 93 monthsPopulation: The safety population was defined as participants who received any amount of any component of study treatment. Participants were analyzed according to the treatment received.
Percentage of participants with Adverse Events (AEs) leading to withdrawal of any study treatment assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
Outcome measures
| Measure |
Placebo+Gemcitabine+Carboplatin/Cisplatin
n=454 Participants
Participants received blinded placebo matched to atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
|
Atezolizumab+Gemcitabine+Carboplatin/Cisplatin
n=389 Participants
Participants received blinded atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
|
Atezolizumab Monotherapy
n=354 Participants
Eligible participants received open-label atezolizumab as monotherapy.
|
|---|---|---|---|
|
Percentage of Participants With Adverse Events (AEs) Leading to Withdrawal of Any Study Treatment
|
36.3 Percentage of Participants
|
33.9 Percentage of Participants
|
9.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline up to 93 monthsPopulation: The safety population was defined as participants who received any amount of any component of study treatment. Participants were analyzed according to the treatment received.
Percentage of participants with atezolizumab-specific Adverse Events of Special Interest (AESIs) Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
Outcome measures
| Measure |
Placebo+Gemcitabine+Carboplatin/Cisplatin
n=454 Participants
Participants received blinded placebo matched to atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
|
Atezolizumab+Gemcitabine+Carboplatin/Cisplatin
n=389 Participants
Participants received blinded atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
|
Atezolizumab Monotherapy
n=354 Participants
Eligible participants received open-label atezolizumab as monotherapy.
|
|---|---|---|---|
|
Percentage of Participants With Atezolizumab-Specific Adverse Events of Special Interest (AESIs)
|
53.3 Percentage of Participants
|
35.5 Percentage of Participants
|
39.5 Percentage of Participants
|
Adverse Events
Placebo+Gemcitabine+Carboplatin/Cisplatin
Serious events: 197 serious events
Other events: 379 other events
Deaths: 303 deaths
Atezolizumab+Gemcitabine+Carboplatin/Cisplatin
Serious events: 244 serious events
Other events: 441 other events
Deaths: 332 deaths
Atezolizumab Monotherapy
Serious events: 163 serious events
Other events: 300 other events
Deaths: 272 deaths
Serious adverse events
| Measure |
Placebo+Gemcitabine+Carboplatin/Cisplatin
n=389 participants at risk
Participants received blinded placebo matched to atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
|
Atezolizumab+Gemcitabine+Carboplatin/Cisplatin
n=454 participants at risk
Participants received blinded atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
|
Atezolizumab Monotherapy
n=354 participants at risk
Eligible participants received open-label atezolizumab as monotherapy.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
4.9%
19/389 • Number of events 26 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
6.6%
30/454 • Number of events 34 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
1.1%
4/354 • Number of events 4 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.3%
9/389 • Number of events 9 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
3.1%
14/454 • Number of events 15 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Blood and lymphatic system disorders
Haematotoxicity
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.44%
2/454 • Number of events 3 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.56%
2/354 • Number of events 2 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Blood and lymphatic system disorders
Myelosuppression
|
0.77%
3/389 • Number of events 7 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.66%
3/454 • Number of events 6 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.0%
4/389 • Number of events 5 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
1.8%
8/454 • Number of events 10 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
1.0%
4/389 • Number of events 4 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
1.3%
6/454 • Number of events 6 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.7%
22/389 • Number of events 28 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
4.6%
21/454 • Number of events 30 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.66%
3/454 • Number of events 3 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.56%
2/354 • Number of events 3 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Cardiac disorders
Angina unstable
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Cardiac disorders
Arrhythmia
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Cardiac disorders
Atrial fibrillation
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.44%
2/454 • Number of events 2 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.44%
2/454 • Number of events 2 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Cardiac disorders
Cardiac arrest
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.66%
3/454 • Number of events 3 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Cardiac disorders
Cardiac failure acute
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Cardiac disorders
Myocardial infarction
|
0.51%
2/389 • Number of events 2 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.44%
2/454 • Number of events 2 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Cardiac disorders
Sinus arrest
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Congenital, familial and genetic disorders
Congenital cystic kidney disease
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Ear and labyrinth disorders
Deafness
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Endocrine disorders
Hypophysitis
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Endocrine disorders
Hypopituitarism
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Endocrine disorders
Hypothyroidism
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Gastrointestinal disorders
Abdominal incarcerated hernia
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.44%
2/454 • Number of events 2 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.56%
2/354 • Number of events 2 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Gastrointestinal disorders
Autoimmune pancreatitis
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Gastrointestinal disorders
Colitis
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Gastrointestinal disorders
Constipation
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.77%
3/389 • Number of events 3 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.88%
4/454 • Number of events 4 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.85%
3/354 • Number of events 3 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Gastrointestinal disorders
Enterocutaneous fistula
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Gastrointestinal disorders
Gastritis
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Gastrointestinal disorders
Haemorrhoids thrombosed
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Gastrointestinal disorders
Ileal ulcer
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Gastrointestinal disorders
Ileus
|
0.77%
3/389 • Number of events 3 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.85%
3/354 • Number of events 3 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.77%
3/389 • Number of events 3 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.66%
3/454 • Number of events 3 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
2.0%
7/354 • Number of events 8 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Gastrointestinal disorders
Rectal obstruction
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.44%
2/454 • Number of events 2 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.56%
2/354 • Number of events 2 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Gastrointestinal disorders
Stomatitis
|
0.51%
2/389 • Number of events 2 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Gastrointestinal disorders
Volvulus
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Gastrointestinal disorders
Vomiting
|
0.77%
3/389 • Number of events 3 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
1.1%
5/454 • Number of events 6 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
General disorders
Accidental death
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
General disorders
Asthenia
|
0.51%
2/389 • Number of events 2 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.88%
4/454 • Number of events 4 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.85%
3/354 • Number of events 3 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
General disorders
Chills
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
General disorders
Death
|
1.8%
7/389 • Number of events 7 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
1.3%
6/454 • Number of events 6 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.56%
2/354 • Number of events 2 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
General disorders
Fatigue
|
1.0%
4/389 • Number of events 4 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.66%
3/454 • Number of events 3 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.56%
2/354 • Number of events 2 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
General disorders
General physical health deterioration
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
General disorders
Malaise
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.44%
2/454 • Number of events 2 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
General disorders
Oedema peripheral
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
General disorders
Pain
|
0.51%
2/389 • Number of events 2 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
1.1%
5/454 • Number of events 6 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
1.1%
4/354 • Number of events 4 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
General disorders
Pyrexia
|
3.1%
12/389 • Number of events 13 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
4.0%
18/454 • Number of events 19 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
2.5%
9/354 • Number of events 11 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
General disorders
Sudden cardiac death
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
General disorders
Suprapubic pain
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.56%
2/354 • Number of events 2 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.44%
2/454 • Number of events 2 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Hepatobiliary disorders
Hepatitis toxic
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Immune system disorders
Anaphylactic reaction
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Immune system disorders
Anaphylactic shock
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Infections and infestations
Appendicitis
|
0.51%
2/389 • Number of events 2 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Infections and infestations
Bacteraemia
|
0.26%
1/389 • Number of events 2 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.44%
2/454 • Number of events 2 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Infections and infestations
COVID-19
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Infections and infestations
Campylobacter infection
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.44%
2/454 • Number of events 3 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Infections and infestations
Cystitis
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.44%
2/454 • Number of events 2 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 2 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Infections and infestations
Emphysematous pyelonephritis
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Infections and infestations
Encephalitis
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Infections and infestations
Endocarditis
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 2 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Infections and infestations
Infected skin ulcer
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Infections and infestations
Infection
|
0.51%
2/389 • Number of events 2 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.44%
2/454 • Number of events 2 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.85%
3/354 • Number of events 3 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Infections and infestations
Influenza
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Infections and infestations
Kidney infection
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Infections and infestations
Klebsiella sepsis
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Infections and infestations
Muscle abscess
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Infections and infestations
Norovirus infection
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Infections and infestations
Orchitis
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Infections and infestations
Peritonitis
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Infections and infestations
Pneumonia
|
2.1%
8/389 • Number of events 8 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
4.6%
21/454 • Number of events 24 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
2.3%
8/354 • Number of events 8 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Infections and infestations
Pneumonia aspiration
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.56%
2/354 • Number of events 2 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Infections and infestations
Pseudomonal bacteraemia
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Infections and infestations
Pulmonary sepsis
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Infections and infestations
Pyelonephritis
|
0.77%
3/389 • Number of events 3 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.85%
3/354 • Number of events 3 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Infections and infestations
Pyelonephritis acute
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.88%
4/454 • Number of events 9 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Infections and infestations
Respiratory tract infection
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.66%
3/454 • Number of events 3 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.56%
2/354 • Number of events 2 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Infections and infestations
Sepsis
|
2.1%
8/389 • Number of events 9 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
1.8%
8/454 • Number of events 9 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Infections and infestations
Septic shock
|
0.51%
2/389 • Number of events 2 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.44%
2/454 • Number of events 2 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.85%
3/354 • Number of events 3 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Infections and infestations
Skin infection
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Infections and infestations
Subcutaneous abscess
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Infections and infestations
Tracheobronchitis
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Infections and infestations
Urinary tract infection
|
7.7%
30/389 • Number of events 42 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
9.0%
41/454 • Number of events 62 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
6.2%
22/354 • Number of events 23 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.51%
2/389 • Number of events 2 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Infections and infestations
Urinary tract infection fungal
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Infections and infestations
Urinary tract infection staphylococcal
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Infections and infestations
Urosepsis
|
1.0%
4/389 • Number of events 4 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.66%
3/454 • Number of events 3 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
1.4%
5/354 • Number of events 5 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Infections and infestations
Vascular device infection
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.44%
2/454 • Number of events 2 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Injury, poisoning and procedural complications
Postoperative adhesion
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Injury, poisoning and procedural complications
Procedural intestinal perforation
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Injury, poisoning and procedural complications
Stoma prolapse
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Injury, poisoning and procedural complications
Stoma site haemorrhage
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Injury, poisoning and procedural complications
Stoma site pain
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.44%
2/454 • Number of events 2 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Injury, poisoning and procedural complications
Unintentional medical device removal
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Injury, poisoning and procedural complications
Urinary tract stoma complication
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Injury, poisoning and procedural complications
Urostomy complication
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Investigations
Alanine aminotransferase increased
|
0.26%
1/389 • Number of events 2 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Investigations
Aspartate aminotransferase increased
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Investigations
Blood creatinine increased
|
1.5%
6/389 • Number of events 7 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.88%
4/454 • Number of events 5 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Investigations
Liver function test abnormal
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Investigations
Neutrophil count decreased
|
1.8%
7/389 • Number of events 8 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.66%
3/454 • Number of events 3 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Investigations
Platelet count decreased
|
3.1%
12/389 • Number of events 18 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
3.1%
14/454 • Number of events 23 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Investigations
Transaminases increased
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Investigations
Weight decreased
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Investigations
White blood cell count decreased
|
0.77%
3/389 • Number of events 4 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.56%
2/354 • Number of events 2 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.51%
2/389 • Number of events 2 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.44%
2/454 • Number of events 2 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Metabolism and nutrition disorders
Diabetic metabolic decompensation
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.56%
2/354 • Number of events 3 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Metabolism and nutrition disorders
Hypercreatininaemia
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.44%
2/454 • Number of events 2 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.51%
2/389 • Number of events 2 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.51%
2/389 • Number of events 2 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.77%
3/389 • Number of events 3 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.66%
3/454 • Number of events 3 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Osteoporotic fracture
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.56%
2/354 • Number of events 2 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Nervous system disorders
Ataxia
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Nervous system disorders
Autoimmune encephalopathy
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Nervous system disorders
Central nervous system haemorrhage
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Nervous system disorders
Cerebral artery embolism
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.44%
2/454 • Number of events 2 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Nervous system disorders
Demyelination
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Nervous system disorders
Embolic stroke
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.44%
2/454 • Number of events 2 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Nervous system disorders
Headache
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Nervous system disorders
Hemianopia
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Nervous system disorders
Intraventricular haemorrhage
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Nervous system disorders
Ischaemic stroke
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.66%
3/454 • Number of events 3 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Nervous system disorders
Lumbosacral radiculopathy
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Nervous system disorders
Migraine
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Nervous system disorders
Miller Fisher syndrome
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Nervous system disorders
Myasthenia gravis
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Nervous system disorders
Myasthenic syndrome
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Nervous system disorders
Paraparesis
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Nervous system disorders
Presyncope
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Nervous system disorders
Seizure
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Nervous system disorders
Spinal cord compression
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Nervous system disorders
Syncope
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.66%
3/454 • Number of events 3 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.56%
2/354 • Number of events 2 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.44%
2/454 • Number of events 2 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Product Issues
Device dislocation
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Product Issues
Device occlusion
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Psychiatric disorders
Confusional state
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Psychiatric disorders
Delirium
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Renal and urinary disorders
Acute kidney injury
|
3.1%
12/389 • Number of events 12 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
3.3%
15/454 • Number of events 16 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
2.3%
8/354 • Number of events 8 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Renal and urinary disorders
Anuria
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Renal and urinary disorders
Autoimmune nephritis
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Renal and urinary disorders
Bladder pain
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Renal and urinary disorders
Bladder tamponade
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Renal and urinary disorders
Haematuria
|
2.6%
10/389 • Number of events 11 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
2.2%
10/454 • Number of events 11 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
3.7%
13/354 • Number of events 13 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.77%
3/389 • Number of events 3 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.85%
3/354 • Number of events 3 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Renal and urinary disorders
Proteinuria
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Renal and urinary disorders
Renal disorder
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Renal and urinary disorders
Renal failure
|
0.51%
2/389 • Number of events 2 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.66%
3/454 • Number of events 3 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
2.3%
8/354 • Number of events 8 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Renal and urinary disorders
Renal impairment
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
1.1%
5/454 • Number of events 5 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.56%
2/354 • Number of events 2 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Renal and urinary disorders
Renal injury
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Renal and urinary disorders
Renal tubular injury
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.66%
3/454 • Number of events 5 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Renal and urinary disorders
Ureteric obstruction
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Renal and urinary disorders
Urinary fistula
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Renal and urinary disorders
Urinary retention
|
0.51%
2/389 • Number of events 2 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
1.1%
5/454 • Number of events 5 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
1.1%
4/354 • Number of events 5 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.77%
3/389 • Number of events 3 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
1.5%
7/454 • Number of events 7 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.56%
2/354 • Number of events 2 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.51%
2/389 • Number of events 2 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.44%
2/454 • Number of events 2 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
1.8%
8/454 • Number of events 9 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
1.4%
5/354 • Number of events 5 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.85%
3/354 • Number of events 3 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.56%
2/354 • Number of events 2 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.77%
3/389 • Number of events 3 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
1.5%
7/454 • Number of events 7 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
1.1%
4/354 • Number of events 5 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.44%
2/454 • Number of events 2 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.0%
4/389 • Number of events 4 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
1.5%
7/454 • Number of events 8 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.51%
2/389 • Number of events 2 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Skin and subcutaneous tissue disorders
Dermatomyositis
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Skin and subcutaneous tissue disorders
Skin necrosis
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Surgical and medical procedures
Euthanasia
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Surgical and medical procedures
Nephrostomy
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Surgical and medical procedures
Nephrostomy tube removal
|
0.51%
2/389 • Number of events 2 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Vascular disorders
Deep vein thrombosis
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Vascular disorders
Embolism
|
0.51%
2/389 • Number of events 2 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Vascular disorders
Embolism venous
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Vascular disorders
Hypertension
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Vascular disorders
Hypovolaemic shock
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Vascular disorders
Jugular vein thrombosis
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Vascular disorders
Leriche syndrome
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Vascular disorders
Peripheral venous disease
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Vascular disorders
Thrombosis
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Vascular disorders
Venous thrombosis
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder adenocarcinoma
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.26%
1/389 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/454 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Vascular disorders
Angiopathy
|
0.00%
0/389 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.22%
1/454 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
Other adverse events
| Measure |
Placebo+Gemcitabine+Carboplatin/Cisplatin
n=389 participants at risk
Participants received blinded placebo matched to atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
|
Atezolizumab+Gemcitabine+Carboplatin/Cisplatin
n=454 participants at risk
Participants received blinded atezolizumab in combination with open-label platinum-based chemotherapy (gemcitabine with either cisplatin or carboplatin).
|
Atezolizumab Monotherapy
n=354 participants at risk
Eligible participants received open-label atezolizumab as monotherapy.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
66.1%
257/389 • Number of events 481 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
67.8%
308/454 • Number of events 495 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
19.2%
68/354 • Number of events 83 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Blood and lymphatic system disorders
Leukopenia
|
16.5%
64/389 • Number of events 192 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
14.1%
64/454 • Number of events 132 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Blood and lymphatic system disorders
Neutropenia
|
38.0%
148/389 • Number of events 421 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
47.4%
215/454 • Number of events 510 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.56%
2/354 • Number of events 2 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
30.1%
117/389 • Number of events 297 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
40.3%
183/454 • Number of events 378 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
3.4%
12/354 • Number of events 13 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Endocrine disorders
Hyperthyroidism
|
1.5%
6/389 • Number of events 6 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
7.7%
35/454 • Number of events 40 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
5.1%
18/354 • Number of events 20 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Endocrine disorders
Hypothyroidism
|
3.1%
12/389 • Number of events 12 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
9.7%
44/454 • Number of events 47 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
8.5%
30/354 • Number of events 31 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Gastrointestinal disorders
Abdominal pain
|
9.5%
37/389 • Number of events 54 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
9.5%
43/454 • Number of events 53 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
6.2%
22/354 • Number of events 27 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Gastrointestinal disorders
Constipation
|
28.5%
111/389 • Number of events 149 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
30.8%
140/454 • Number of events 187 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
18.9%
67/354 • Number of events 74 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Gastrointestinal disorders
Diarrhoea
|
18.8%
73/389 • Number of events 96 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
21.1%
96/454 • Number of events 146 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
11.9%
42/354 • Number of events 59 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.7%
22/389 • Number of events 28 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
4.4%
20/454 • Number of events 21 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
1.4%
5/354 • Number of events 10 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Gastrointestinal disorders
Nausea
|
46.5%
181/389 • Number of events 317 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
44.5%
202/454 • Number of events 329 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
12.1%
43/354 • Number of events 53 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Gastrointestinal disorders
Vomiting
|
27.2%
106/389 • Number of events 175 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
26.9%
122/454 • Number of events 178 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
9.3%
33/354 • Number of events 43 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
General disorders
Asthenia
|
25.2%
98/389 • Number of events 158 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
29.5%
134/454 • Number of events 208 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
14.4%
51/354 • Number of events 78 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
General disorders
Fatigue
|
31.4%
122/389 • Number of events 182 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
29.5%
134/454 • Number of events 185 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
18.1%
64/354 • Number of events 83 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
General disorders
Malaise
|
6.2%
24/389 • Number of events 35 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
4.0%
18/454 • Number of events 34 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
1.7%
6/354 • Number of events 6 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
General disorders
Oedema peripheral
|
14.4%
56/389 • Number of events 68 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
11.7%
53/454 • Number of events 68 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
11.6%
41/354 • Number of events 56 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
General disorders
Pyrexia
|
17.5%
68/389 • Number of events 113 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
26.9%
122/454 • Number of events 173 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
12.1%
43/354 • Number of events 57 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Infections and infestations
Nasopharyngitis
|
5.1%
20/389 • Number of events 25 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
7.3%
33/454 • Number of events 44 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
5.4%
19/354 • Number of events 31 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Infections and infestations
Upper respiratory tract infection
|
4.9%
19/389 • Number of events 26 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
6.6%
30/454 • Number of events 36 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
5.1%
18/354 • Number of events 22 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Infections and infestations
Urinary tract infection
|
15.7%
61/389 • Number of events 91 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
20.3%
92/454 • Number of events 141 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
16.7%
59/354 • Number of events 102 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Investigations
Alanine aminotransferase increased
|
6.7%
26/389 • Number of events 32 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
10.4%
47/454 • Number of events 58 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
6.8%
24/354 • Number of events 28 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Investigations
Aspartate aminotransferase increased
|
4.4%
17/389 • Number of events 28 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
10.6%
48/454 • Number of events 63 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
6.2%
22/354 • Number of events 26 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Investigations
Blood alkaline phosphatase increased
|
2.6%
10/389 • Number of events 15 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
5.9%
27/454 • Number of events 34 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
6.2%
22/354 • Number of events 29 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Investigations
Blood creatinine increased
|
11.6%
45/389 • Number of events 64 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
14.5%
66/454 • Number of events 89 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
7.9%
28/354 • Number of events 35 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Investigations
Neutrophil count decreased
|
33.2%
129/389 • Number of events 344 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
26.2%
119/454 • Number of events 331 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/354 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Investigations
Platelet count decreased
|
35.5%
138/389 • Number of events 331 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
29.1%
132/454 • Number of events 350 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
1.4%
5/354 • Number of events 7 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Investigations
Weight decreased
|
6.4%
25/389 • Number of events 25 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
6.6%
30/454 • Number of events 35 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
6.5%
23/354 • Number of events 23 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Investigations
White blood cell count decreased
|
15.2%
59/389 • Number of events 165 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
13.7%
62/454 • Number of events 144 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.28%
1/354 • Number of events 1 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
30.6%
119/389 • Number of events 165 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
31.7%
144/454 • Number of events 215 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
19.5%
69/354 • Number of events 72 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
3.1%
12/389 • Number of events 21 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
5.7%
26/454 • Number of events 30 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
4.0%
14/354 • Number of events 35 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
7.5%
29/389 • Number of events 39 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
5.3%
24/454 • Number of events 39 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
3.7%
13/354 • Number of events 19 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
3.9%
15/389 • Number of events 24 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
4.6%
21/454 • Number of events 27 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
5.4%
19/354 • Number of events 20 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
5.7%
22/389 • Number of events 27 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
5.7%
26/454 • Number of events 31 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
2.3%
8/354 • Number of events 16 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
4.1%
16/389 • Number of events 21 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
6.6%
30/454 • Number of events 36 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
2.5%
9/354 • Number of events 11 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.3%
44/389 • Number of events 57 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
13.0%
59/454 • Number of events 84 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
11.9%
42/354 • Number of events 62 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.8%
46/389 • Number of events 57 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
12.3%
56/454 • Number of events 67 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
9.6%
34/354 • Number of events 40 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.9%
23/389 • Number of events 34 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
5.9%
27/454 • Number of events 29 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
6.5%
23/354 • Number of events 30 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.7%
30/389 • Number of events 37 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
7.7%
35/454 • Number of events 43 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
6.2%
22/354 • Number of events 25 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Nervous system disorders
Dizziness
|
10.0%
39/389 • Number of events 51 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
9.9%
45/454 • Number of events 60 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
5.4%
19/354 • Number of events 20 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Nervous system disorders
Headache
|
8.7%
34/389 • Number of events 43 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
9.3%
42/454 • Number of events 65 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
7.1%
25/354 • Number of events 36 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Nervous system disorders
Neuropathy peripheral
|
5.9%
23/389 • Number of events 25 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
3.7%
17/454 • Number of events 19 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
1.7%
6/354 • Number of events 8 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Psychiatric disorders
Insomnia
|
8.7%
34/389 • Number of events 37 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
7.9%
36/454 • Number of events 39 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
5.4%
19/354 • Number of events 20 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Renal and urinary disorders
Dysuria
|
5.1%
20/389 • Number of events 26 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
6.4%
29/454 • Number of events 41 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
5.6%
20/354 • Number of events 23 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Renal and urinary disorders
Haematuria
|
13.1%
51/389 • Number of events 65 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
16.1%
73/454 • Number of events 104 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
13.6%
48/354 • Number of events 56 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.8%
38/389 • Number of events 46 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
12.8%
58/454 • Number of events 67 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
8.5%
30/354 • Number of events 49 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.5%
33/389 • Number of events 43 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
9.5%
43/454 • Number of events 54 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
7.1%
25/354 • Number of events 29 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
12.6%
49/389 • Number of events 50 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
7.3%
33/454 • Number of events 35 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.56%
2/354 • Number of events 2 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.5%
33/389 • Number of events 38 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
18.5%
84/454 • Number of events 123 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
11.6%
41/354 • Number of events 66 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.1%
43/389 • Number of events 52 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
20.0%
91/454 • Number of events 117 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
7.6%
27/354 • Number of events 32 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Vascular disorders
Hypertension
|
8.2%
32/389 • Number of events 42 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
10.1%
46/454 • Number of events 66 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
5.9%
21/354 • Number of events 26 • From the first study drug to the data cutoff date: 9 April 2024 (up to approximately 93 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. There were 6 patients randomized to Atezo monotherapy after approval of Protocol version 6 who received open-label Atezo and chemo, and were pooled with patients in Atezo+chemo for safety analyses. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
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