Trial Outcomes & Findings for Study to Assess Safety and Efficacy of Atezolizumab (MPDL3280A) Compared to Best Supportive Care Following Chemotherapy in Patients With Lung Cancer [IMpower010] (NCT NCT02486718)
NCT ID: NCT02486718
Last Updated: 2026-01-14
Results Overview
DFS was defined as the time from randomization to the first recurrence of NSCLC or occurrence of new primary NSCLC as determined by the investigator or death, whichever occurs first. Kaplan-Meier methodology was used to estimate the median DFS for each treatment arm.
ACTIVE_NOT_RECRUITING
PHASE3
1280 participants
Up to 95 months
2026-01-14
Participant Flow
A total of 1280 participants with resectable Stage IB-IIIA non-small cell lung cancer (NSCLC) were enrolled in this study. Participants took part in the study at 227 investigative sites across 22 countries. The study is still ongoing.
The study consists of 2 phases, an enrollment phase in which participants received up to 4 cycles of adjuvant cisplatin-based chemotherapy followed by randomized phase in which eligible participants were randomized to receive atezolizumab or best supportive care (BSC) i.e.no treatment.
Participant milestones
| Measure |
Best Supportive Care (BSC)
Participants who did not experience disease recurrence after chemotherapy in enrollment phase received no treatment in the randomization phase BSC arm.
|
Enrollment Phase
All participants received up to four 21-day cycles of cisplatin-based chemotherapy (cisplatin plus either vinorelbine or docetaxel or gemcitabine or pemetrexed \[non-squamous cell NSCLC only\] based on investigator's choice), unless unacceptable toxicity, disease relapse, or participant's decision to discontinue occurred.
|
Atezolizumab
Participants who did not experience disease recurrence after chemotherapy in enrollment phase received 1200 milligrams (mg) of atezolizumab intravenously (IV) every 3 weeks (Q3W) for sixteen 21-day cycles in the randomization phase.
|
|---|---|---|---|
|
Enrollment Phase
STARTED
|
0
|
1280
|
0
|
|
Enrollment Phase
Enrolled Safety-evaluable Population
|
0
|
1269
|
0
|
|
Enrollment Phase
COMPLETED
|
0
|
1005
|
0
|
|
Enrollment Phase
NOT COMPLETED
|
0
|
275
|
0
|
|
Randomized Phase
STARTED
|
498
|
0
|
507
|
|
Randomized Phase
Randomized Safety Population
|
495
|
0
|
495
|
|
Randomized Phase
COMPLETED
|
0
|
0
|
0
|
|
Randomized Phase
NOT COMPLETED
|
498
|
0
|
507
|
Reasons for withdrawal
| Measure |
Best Supportive Care (BSC)
Participants who did not experience disease recurrence after chemotherapy in enrollment phase received no treatment in the randomization phase BSC arm.
|
Enrollment Phase
All participants received up to four 21-day cycles of cisplatin-based chemotherapy (cisplatin plus either vinorelbine or docetaxel or gemcitabine or pemetrexed \[non-squamous cell NSCLC only\] based on investigator's choice), unless unacceptable toxicity, disease relapse, or participant's decision to discontinue occurred.
|
Atezolizumab
Participants who did not experience disease recurrence after chemotherapy in enrollment phase received 1200 milligrams (mg) of atezolizumab intravenously (IV) every 3 weeks (Q3W) for sixteen 21-day cycles in the randomization phase.
|
|---|---|---|---|
|
Enrollment Phase
Death
|
0
|
19
|
0
|
|
Enrollment Phase
Symptomatic deterioration
|
0
|
1
|
0
|
|
Enrollment Phase
Withdrawal by Subject
|
0
|
86
|
0
|
|
Enrollment Phase
Protocol Violation
|
0
|
18
|
0
|
|
Enrollment Phase
Physician Decision
|
0
|
18
|
0
|
|
Enrollment Phase
Reason not provided
|
0
|
41
|
0
|
|
Enrollment Phase
Disease relapse
|
0
|
54
|
0
|
|
Enrollment Phase
Lost to Follow-up
|
0
|
4
|
0
|
|
Enrollment Phase
Adverse Event
|
0
|
34
|
0
|
|
Randomized Phase
Withdrawal by Subject
|
47
|
0
|
44
|
|
Randomized Phase
Protocol Violation
|
0
|
0
|
2
|
|
Randomized Phase
Physician Decision
|
3
|
0
|
0
|
|
Randomized Phase
Lost to Follow-up
|
11
|
0
|
5
|
|
Randomized Phase
Disease Relapse
|
0
|
0
|
1
|
|
Randomized Phase
Death
|
155
|
0
|
154
|
|
Randomized Phase
Ongoing
|
282
|
0
|
301
|
Baseline Characteristics
Study to Assess Safety and Efficacy of Atezolizumab (MPDL3280A) Compared to Best Supportive Care Following Chemotherapy in Patients With Lung Cancer [IMpower010]
Baseline characteristics by cohort
| Measure |
Enrollment Phase
n=1280 Participants
All participants received up to four 21-day cycles of cisplatin-based chemotherapy (cisplatin plus either vinorelbine or docetaxel or gemcitabine or pemetrexed \[non-squamous cell NSCLC only\] based on investigator's choice), unless unacceptable toxicity, disease relapse, or participant's decision to discontinue occurred.
|
|---|---|
|
Age, Continuous
|
61.4 years
STANDARD_DEVIATION 8.7 • n=14 Participants
|
|
Sex: Female, Male
Female
|
427 Participants
n=14 Participants
|
|
Sex: Female, Male
Male
|
853 Participants
n=14 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
18 Participants
n=14 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1219 Participants
n=14 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
43 Participants
n=14 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Asian
|
307 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=14 Participants
|
|
Race (NIH/OMB)
White
|
935 Participants
n=14 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
27 Participants
n=14 Participants
|
PRIMARY outcome
Timeframe: Up to 95 monthsPopulation: Randomized ITT population was defined as all randomized participants with resected Stage IB \[tumors ≥ 4 centimetres (cm)\]-IIIA NSCLC whether or not the participant received the assigned treatment.
DFS was defined as the time from randomization to the first recurrence of NSCLC or occurrence of new primary NSCLC as determined by the investigator or death, whichever occurs first. Kaplan-Meier methodology was used to estimate the median DFS for each treatment arm.
Outcome measures
| Measure |
Best Supportive Care (BSC)
n=498 Participants
Participants who did not experience disease recurrence after chemotherapy in enrollment phase received no treatment in the randomization phase BSC arm.
|
Atezolizumab
n=507 Participants
Participants who did not experience disease recurrence after chemotherapy in enrollment phase received 1200 milligrams (mg) of atezolizumab intravenously (IV) every 3 weeks (Q3W) for sixteen 21-day cycles in the randomization phase.
|
|---|---|---|
|
Disease-Free Survival (DFS) in Intent-to-treat (ITT) Population
|
47.8 months
Interval 37.0 to 65.8
|
65.6 months
Interval 52.4 to
The upper limit of the 95% confidence interval (CI) was not estimable due to insufficient number of participants with events.
|
PRIMARY outcome
Timeframe: Up to 95 monthsPopulation: Stage II-IIIA population was defined as all randomized participants with extent of disease as either Stage II or Stage IIIA, and is a subset of the ITT population. Randomized ITT population was defined as all randomized participants with resected Stage IB (tumors ≥ 4 cm)-IIIA NSCLC whether or not the participant received the assigned treatment.
DFS was defined as the time from randomization to the first recurrence of NSCLC or occurrence of new primary NSCLC as determined by the investigator or death, whichever occurs first. DFS was analyzed in participants with disease stage II-IIIA. Kaplan-Meier methodology was used to estimate the median DFS for each treatment arm.
Outcome measures
| Measure |
Best Supportive Care (BSC)
n=440 Participants
Participants who did not experience disease recurrence after chemotherapy in enrollment phase received no treatment in the randomization phase BSC arm.
|
Atezolizumab
n=442 Participants
Participants who did not experience disease recurrence after chemotherapy in enrollment phase received 1200 milligrams (mg) of atezolizumab intravenously (IV) every 3 weeks (Q3W) for sixteen 21-day cycles in the randomization phase.
|
|---|---|---|
|
DFS in All Randomized Stage II-IIIA Population
|
40.8 months
Interval 31.4 to 57.1
|
57.4 months
Interval 42.2 to
The upper limit of the 95% CI was not estimable due to insufficient number of participants with events.
|
PRIMARY outcome
Timeframe: Up to 95 monthsPopulation: PD-L1 subpopulation, defined as ≥1% TC expression by the SP263 immunohistochemistry (IHC) assay, included Stage II-IIIA population with valid PD-L1 SP263 measurement at baseline. Stage II-IIIA population included all randomized participants with extent of disease as either Stage II or Stage III, \& is a subset of ITT population. Randomized ITT population included all randomized participants with resected Stage IB (tumors ≥ 4 cm)-IIIA NSCLC whether the participant received the assigned treatment.
DFS was defined as the time from randomization to the first recurrence of NSCLC or occurrence of new primary NSCLC as determined by the investigator or death, whichever occurs first. DFS was analyzed in PD-L1 ≥1% subpopulation within the Stage II-IIIA population. Kaplan-Meier methodology was used to estimate the median DFS for each treatment arm.
Outcome measures
| Measure |
Best Supportive Care (BSC)
n=228 Participants
Participants who did not experience disease recurrence after chemotherapy in enrollment phase received no treatment in the randomization phase BSC arm.
|
Atezolizumab
n=248 Participants
Participants who did not experience disease recurrence after chemotherapy in enrollment phase received 1200 milligrams (mg) of atezolizumab intravenously (IV) every 3 weeks (Q3W) for sixteen 21-day cycles in the randomization phase.
|
|---|---|---|
|
DFS in the Programmed Death-ligand 1 (PD-L1) SP263 ≥ 1% Tumor Cell (TC) Subpopulation Within the Stage II-IIIA Population
|
37.3 months
Interval 30.1 to 57.8
|
68.5 months
Interval 51.8 to
The upper limit of the 95% CI was not estimable due to insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Up to 20 yearsOS was defined as the time from randomization to death from any cause.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Year 3Population: Randomized ITT population was defined as all randomized participants with resected Stage IB (tumors ≥ 4 cm)-IIIA NSCLC whether or not the participant received the assigned treatment.
DFS rate was defined as percentage of participants who were disease-free at Year 3. The DFS rate was estimated by the Kaplan-Meier methodology for each treatment arm. Percentages have been rounded off to the nearest decimal.
Outcome measures
| Measure |
Best Supportive Care (BSC)
n=498 Participants
Participants who did not experience disease recurrence after chemotherapy in enrollment phase received no treatment in the randomization phase BSC arm.
|
Atezolizumab
n=507 Participants
Participants who did not experience disease recurrence after chemotherapy in enrollment phase received 1200 milligrams (mg) of atezolizumab intravenously (IV) every 3 weeks (Q3W) for sixteen 21-day cycles in the randomization phase.
|
|---|---|---|
|
Disease-free Rate at Year 3 in ITT Population
|
55.45 percentage of participants
Interval 50.95 to 59.95
|
61.43 percentage of participants
Interval 57.09 to 65.77
|
SECONDARY outcome
Timeframe: Year 3Population: Stage II-IIIA population was defined as all randomized participants with extent of disease as either Stage II or Stage III, and is a subset of the ITT population. Randomized ITT population was defined as all randomized participants with resected Stage IB (tumors ≥ 4 cm)-IIIA NSCLC whether or not the participant received the assigned treatment.
DFS rate was defined as percentage of participants who were disease-free at Year 3. DFS rate was analyzed in participants with disease stage II-IIIA. The DFS rate was estimated by the Kaplan-Meier methodology for each treatment arm. Percentages have been rounded off to the nearest decimal.
Outcome measures
| Measure |
Best Supportive Care (BSC)
n=440 Participants
Participants who did not experience disease recurrence after chemotherapy in enrollment phase received no treatment in the randomization phase BSC arm.
|
Atezolizumab
n=442 Participants
Participants who did not experience disease recurrence after chemotherapy in enrollment phase received 1200 milligrams (mg) of atezolizumab intravenously (IV) every 3 weeks (Q3W) for sixteen 21-day cycles in the randomization phase.
|
|---|---|---|
|
Disease-free Rate at Year 3 in All Randomized Stage II-IIIA Population
|
52.64 percentage of participants
Interval 47.83 to 57.46
|
59.30 percentage of participants
Interval 54.61 to 63.98
|
SECONDARY outcome
Timeframe: Year 3Population: PD-L1 subpopulation, defined as ≥ 1% TC expression by the SP263 IHC assay, included Stage II-IIIA population with valid PD-L1 SP263 measurement at baseline. Stage II-IIIA population included all randomized participants with extent of disease as either Stage II or Stage III, \& is a subset of ITT population. Randomized ITT population included all randomized participants with resected Stage IB (tumors ≥ 4 cm)-IIIA NSCLC whether the participant received the assigned treatment.
DFS rate was defined as percentage of participants who were disease-free at Year 3. DFS rate was analyzed in PD-L1 subpopulation within the Stage II-IIIA population. The DFS rate was estimated by the Kaplan-Meier methodology for each treatment arm. Percentages have been rounded off to the nearest decimal.
Outcome measures
| Measure |
Best Supportive Care (BSC)
n=228 Participants
Participants who did not experience disease recurrence after chemotherapy in enrollment phase received no treatment in the randomization phase BSC arm.
|
Atezolizumab
n=248 Participants
Participants who did not experience disease recurrence after chemotherapy in enrollment phase received 1200 milligrams (mg) of atezolizumab intravenously (IV) every 3 weeks (Q3W) for sixteen 21-day cycles in the randomization phase.
|
|---|---|---|
|
Disease-free Rate at Year 3 in PD-L1 (SP263 ≥ 1% TC) Subpopulation Within the Stage II-IIIA Population
|
52.05 percentage of participants
Interval 45.35 to 58.75
|
62.72 percentage of participants
Interval 56.54 to 68.9
|
SECONDARY outcome
Timeframe: Year 5Population: Randomized ITT population was defined as all randomized participants with resected Stage IB (tumors ≥ 4 cm)-IIIA NSCLC whether or not the participant received the assigned treatment.
DFS rate was defined as percentage of participants who were disease-free at Year 5. The DFS rate was estimated by the Kaplan-Meier methodology for each treatment arm. Percentages have been rounded off to the nearest decimal.
Outcome measures
| Measure |
Best Supportive Care (BSC)
n=498 Participants
Participants who did not experience disease recurrence after chemotherapy in enrollment phase received no treatment in the randomization phase BSC arm.
|
Atezolizumab
n=507 Participants
Participants who did not experience disease recurrence after chemotherapy in enrollment phase received 1200 milligrams (mg) of atezolizumab intravenously (IV) every 3 weeks (Q3W) for sixteen 21-day cycles in the randomization phase.
|
|---|---|---|
|
Disease-free Rate at Year 5 in ITT Population
|
46.48 percentage of participants
Interval 41.91 to 51.05
|
51.96 percentage of participants
Interval 47.45 to 56.46
|
SECONDARY outcome
Timeframe: Year 5Population: Stage II-IIIA population was defined as all randomized participants with extent of disease as either Stage II or Stage III, and is a subset of the ITT population. Randomized ITT population was defined as all randomized participants with resected Stage IB (tumors ≥ 4 cm)-IIIA NSCLC whether or not the participant received the assigned treatment.
DFS rate was defined as percentage of participants who were disease-free at Year 5. DFS rate was analyzed in participants with disease stage II-IIIA. The DFS rate was estimated by the Kaplan-Meier methodology for each treatment arm. Percentages have been rounded off to the nearest decimal.
Outcome measures
| Measure |
Best Supportive Care (BSC)
n=440 Participants
Participants who did not experience disease recurrence after chemotherapy in enrollment phase received no treatment in the randomization phase BSC arm.
|
Atezolizumab
n=442 Participants
Participants who did not experience disease recurrence after chemotherapy in enrollment phase received 1200 milligrams (mg) of atezolizumab intravenously (IV) every 3 weeks (Q3W) for sixteen 21-day cycles in the randomization phase.
|
|---|---|---|
|
Disease-free Rate at Year 5 in All Randomized Stage II-IIIA Population
|
44.40 percentage of participants
Interval 39.57 to 49.24
|
49.28 percentage of participants
Interval 44.47 to 54.1
|
SECONDARY outcome
Timeframe: Year 5Population: PD-L1 subpopulation, defined as ≥ 1% TC expression by the SP263 IHC assay, included Stage II-IIIA population with valid PD-L1 SP263 measurement at baseline. Stage II-IIIA population included all randomized participants with extent of disease as either Stage II or Stage III, \& is a subset of ITT population. Randomized ITT population included all randomized participants with resected Stage IB (tumors ≥ 4 cm)-IIIA NSCLC whether the participant received the assigned treatment.
DFS rate was defined as percentage of participants who were disease-free at Year 5. DFS rate was analyzed in PD-L1 subpopulation within the Stage II-IIIA population. The DFS rate was estimated by the Kaplan-Meier methodology for each treatment arm. Percentages have been rounded off to the nearest decimal.
Outcome measures
| Measure |
Best Supportive Care (BSC)
n=228 Participants
Participants who did not experience disease recurrence after chemotherapy in enrollment phase received no treatment in the randomization phase BSC arm.
|
Atezolizumab
n=248 Participants
Participants who did not experience disease recurrence after chemotherapy in enrollment phase received 1200 milligrams (mg) of atezolizumab intravenously (IV) every 3 weeks (Q3W) for sixteen 21-day cycles in the randomization phase.
|
|---|---|---|
|
Disease-free Rate at Year 5 in PD-L1 (SP263 ≥ 1% TC) Subpopulation Within the Stage II-IIIA Population
|
42.69 percentage of participants
Interval 36.0 to 49.38
|
53.15 percentage of participants
Interval 46.69 to 59.61
|
SECONDARY outcome
Timeframe: Up to 95 monthsPopulation: PD-L1 subpopulation, defined as ≥50% TC expression by the SP263 IHC assay, included Stage II-IIIA population with valid PD-L1 SP263 measurement at baseline. Stage II-IIIA population included all randomized participants with extent of disease as either Stage II or Stage III, \& is a subset of ITT population. Randomized ITT population included all randomized participants with resected Stage IB (tumors ≥ 4 cm)-IIIA NSCLC whether the participant received the assigned treatment.
DFS was defined as the time from randomization to the first recurrence of NSCLC or occurrence of new primary NSCLC as determined by the investigator or death, whichever occurs first. DFS was analyzed in PD-L1 subpopulation within the Stage II-IIIA population. Kaplan-Meier methodology was used to estimate the median DFS for each treatment arm.
Outcome measures
| Measure |
Best Supportive Care (BSC)
n=114 Participants
Participants who did not experience disease recurrence after chemotherapy in enrollment phase received no treatment in the randomization phase BSC arm.
|
Atezolizumab
n=115 Participants
Participants who did not experience disease recurrence after chemotherapy in enrollment phase received 1200 milligrams (mg) of atezolizumab intravenously (IV) every 3 weeks (Q3W) for sixteen 21-day cycles in the randomization phase.
|
|---|---|---|
|
DFS in the PD-L1 (SP263 ≥ 50% TC) Subpopulation Within the Stage II-IIIA Population
|
41.1 months
Interval 29.7 to
The upper limit of the 95% CI was not estimable due to insufficient number of participants with events.
|
NA months
The median and the 95% CI was not estimable due to insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Up to 20 yearsAn AE is any untoward medical occurrence in a participant when administered a pharmaceutical product regardless of the causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Predose (Hour 0) on Day 1 of Cycles 2, 3, 4, 8, 16 (Cycle length = 21 days), at treatment discontinuation (TD) (up to 12 months), 120 days after last atezolizumab administration (up to 16 months)Population: ADA evaluable population was defined as all randomized participants who received at least one dose of atezolizumab and who have at least one post-baseline ADA result.
The percentage of ATA (Also called anti-drug antibodies (ADA))-positive participants after drug administration were determined for participants exposed to atezolizumab. For determining post-baseline incidence, participants were considered to be ADA-positive if they were ADA-negative or had missing data at baseline but developed an ADA response following study drug exposure, or if they were ADA-positive at baseline and the titer of 1 or more post-baseline samples was at least 0.60 titer units (t.u.) greater than the baseline titer result.
Outcome measures
| Measure |
Best Supportive Care (BSC)
Participants who did not experience disease recurrence after chemotherapy in enrollment phase received no treatment in the randomization phase BSC arm.
|
Atezolizumab
n=487 Participants
Participants who did not experience disease recurrence after chemotherapy in enrollment phase received 1200 milligrams (mg) of atezolizumab intravenously (IV) every 3 weeks (Q3W) for sixteen 21-day cycles in the randomization phase.
|
|---|---|---|
|
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab
|
—
|
31.2 percentage of participants
|
SECONDARY outcome
Timeframe: 30 min post-infusion on Day 1 of Cycle 1 (Cycle length = 21 days)Population: PK-evaluable population was defined as all randomized participants who received any dose of the study treatment and who have evaluable pharmacokinetic samples. Overall number analyzed is the number of participants with data available for analysis.
Outcome measures
| Measure |
Best Supportive Care (BSC)
Participants who did not experience disease recurrence after chemotherapy in enrollment phase received no treatment in the randomization phase BSC arm.
|
Atezolizumab
n=451 Participants
Participants who did not experience disease recurrence after chemotherapy in enrollment phase received 1200 milligrams (mg) of atezolizumab intravenously (IV) every 3 weeks (Q3W) for sixteen 21-day cycles in the randomization phase.
|
|---|---|---|
|
Maximum Plasma Concentration (Cmax) of Atezolizumab
|
—
|
367 micrograms/millilitres (μg/ml)
Geometric Coefficient of Variation 124
|
SECONDARY outcome
Timeframe: Prior to infusion on Day 1 of Cycles 1, 2, 3, 4, 8, 16 (Cycle length = 21 days), at study discontinuation visit (up to 12 months), Day 120 post last dose of atezolizumab (up to 16 months)Population: PK-evaluable population was defined as all randomized participants who received any dose of the study treatment and who have evaluable pharmacokinetic samples. Number analyzed is the number of participants with data available for analyses at the specified timepoints.
Outcome measures
| Measure |
Best Supportive Care (BSC)
Participants who did not experience disease recurrence after chemotherapy in enrollment phase received no treatment in the randomization phase BSC arm.
|
Atezolizumab
n=493 Participants
Participants who did not experience disease recurrence after chemotherapy in enrollment phase received 1200 milligrams (mg) of atezolizumab intravenously (IV) every 3 weeks (Q3W) for sixteen 21-day cycles in the randomization phase.
|
|---|---|---|
|
Minimum Serum Concentration (Cmin) at Steady-State Within a Dosing Interval of Atezolizumab
Cycle 1 Day 1
|
—
|
367 μg/ml
Geometric Coefficient of Variation 123.5
|
|
Minimum Serum Concentration (Cmin) at Steady-State Within a Dosing Interval of Atezolizumab
Cycle 2 Day 1
|
—
|
87.8 μg/ml
Geometric Coefficient of Variation 79.3
|
|
Minimum Serum Concentration (Cmin) at Steady-State Within a Dosing Interval of Atezolizumab
Cycle 3 Day 1
|
—
|
141 μg/ml
Geometric Coefficient of Variation 58.4
|
|
Minimum Serum Concentration (Cmin) at Steady-State Within a Dosing Interval of Atezolizumab
Cycle 4 Day 1
|
—
|
170 μg/ml
Geometric Coefficient of Variation 57.6
|
|
Minimum Serum Concentration (Cmin) at Steady-State Within a Dosing Interval of Atezolizumab
Cycle 8 Day 1
|
—
|
222 μg/ml
Geometric Coefficient of Variation 40.6
|
|
Minimum Serum Concentration (Cmin) at Steady-State Within a Dosing Interval of Atezolizumab
Cycle 16 Day 1
|
—
|
221 μg/ml
Geometric Coefficient of Variation 87.3
|
|
Minimum Serum Concentration (Cmin) at Steady-State Within a Dosing Interval of Atezolizumab
Treatment Discontinuation Visit
|
—
|
148 μg/ml
Geometric Coefficient of Variation 221.8
|
|
Minimum Serum Concentration (Cmin) at Steady-State Within a Dosing Interval of Atezolizumab
Day 120 Post Last Dose of Atezolizumab
|
—
|
8.58 μg/ml
Geometric Coefficient of Variation 794.8
|
Adverse Events
Enrollment Phase
Best Supportive Care (BSC)
Atezolizumab
Serious adverse events
| Measure |
Enrollment Phase
n=1269 participants at risk
All participants received up to four 21-day cycles of cisplatin-based chemotherapy (cisplatin plus either vinorelbine or docetaxel or gemcitabine or pemetrexed \[non-squamous cell NSCLC only\] based on investigator's choice), unless unacceptable toxicity, disease relapse, or participant's decision to discontinue occurred.
|
Best Supportive Care (BSC)
n=495 participants at risk
Participants who did not experience disease recurrence after chemotherapy in enrollment phase received no treatment in the randomization phase BSC arm.
|
Atezolizumab
n=495 participants at risk
Participants who did not experience disease recurrence after chemotherapy in enrollment phase received 1200 milligrams (mg) of atezolizumab intravenously (IV) every 3 weeks (Q3W) for sixteen 21-day cycles in the randomization phase.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.63%
8/1269 • Number of events 8 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Blood and lymphatic system disorders
Sarcoidosis of lymph node
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.16%
2/1269 • Number of events 2 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Cardiac disorders
Atrial fibrillation
|
0.16%
2/1269 • Number of events 2 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.40%
2/495 • Number of events 2 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Cardiac disorders
Cardiac arrest
|
0.08%
1/1269 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Cardiac disorders
Myocardial infarction
|
0.16%
2/1269 • Number of events 2 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Cardiac disorders
Myocarditis
|
0.08%
1/1269 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Endocrine disorders
Hypopituitarism
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Endocrine disorders
Secondary adrenocortical insufficiency
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.39%
5/1269 • Number of events 5 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.40%
2/495 • Number of events 2 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
General disorders
Chest pain
|
0.08%
1/1269 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
General disorders
Death
|
0.24%
3/1269 • Number of events 3 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
General disorders
General physical health deterioration
|
0.24%
3/1269 • Number of events 3 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
General disorders
Oedema peripheral
|
0.08%
1/1269 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
General disorders
Pyrexia
|
0.16%
2/1269 • Number of events 2 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
1.2%
6/495 • Number of events 6 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.08%
1/1269 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 2 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.08%
1/1269 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.40%
2/495 • Number of events 2 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.40%
2/495 • Number of events 2 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Immune system disorders
Contrast media reaction
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Immune system disorders
Hypersensitivity
|
0.16%
2/1269 • Number of events 2 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Immune system disorders
Immune-mediated adverse reaction
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Immune system disorders
Sarcoidosis
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Infections and infestations
Biliary tract infection
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Infections and infestations
Cellulitis
|
0.08%
1/1269 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 2 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Infections and infestations
Device related infection
|
0.08%
1/1269 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Infections and infestations
Encephalitis
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Infections and infestations
Influenza
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Infections and infestations
Meningitis
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.40%
2/495 • Number of events 2 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Infections and infestations
Otitis media chronic
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Infections and infestations
Pleural infection
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Infections and infestations
Pneumonia
|
1.4%
18/1269 • Number of events 18 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
1.0%
5/495 • Number of events 5 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
1.6%
8/495 • Number of events 9 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Infections and infestations
Respiratory tract infection
|
0.24%
3/1269 • Number of events 3 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Infections and infestations
Sepsis
|
0.39%
5/1269 • Number of events 5 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.40%
2/495 • Number of events 2 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Infections and infestations
Septic shock
|
0.16%
2/1269 • Number of events 2 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.40%
2/495 • Number of events 2 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Infections and infestations
Urinary tract infection
|
0.24%
3/1269 • Number of events 3 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.40%
2/495 • Number of events 2 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Infections and infestations
Viral myocarditis
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Injury, poisoning and procedural complications
Comminuted fracture
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Injury, poisoning and procedural complications
Prescribed overdose
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Injury, poisoning and procedural complications
Urethral stricture traumatic
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Investigations
Blood creatinine increased
|
0.16%
2/1269 • Number of events 2 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Investigations
Platelet count decreased
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Investigations
Weight decreased
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.24%
3/1269 • Number of events 3 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.08%
1/1269 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.16%
2/1269 • Number of events 2 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal squamous cell carcinoma
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intestinal metastasis
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Langerhans' cell histiocytosis
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of head and neck
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Urinary tract neoplasm
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Nervous system disorders
Axonal neuropathy
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Nervous system disorders
Cerebellar infarction
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 2 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Nervous system disorders
Demyelinating polyneuropathy
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Nervous system disorders
Encephalitis autoimmune
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Nervous system disorders
Encephalopathy
|
0.08%
1/1269 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Nervous system disorders
Intracranial haematoma
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.40%
2/495 • Number of events 2 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Nervous system disorders
Syncope
|
0.39%
5/1269 • Number of events 5 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Psychiatric disorders
Depression
|
0.08%
1/1269 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.40%
2/495 • Number of events 3 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Psychiatric disorders
Dissociative disorder
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Psychiatric disorders
Hallucination, visual
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.47%
6/1269 • Number of events 6 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Reproductive system and breast disorders
Adnexal torsion
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Respiratory, thoracic and mediastinal disorders
Alveolitis
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.16%
2/1269 • Number of events 2 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.40%
2/495 • Number of events 3 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.61%
3/495 • Number of events 3 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.81%
4/495 • Number of events 5 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.16%
2/1269 • Number of events 2 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.7%
22/1269 • Number of events 22 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.08%
1/1269 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.40%
2/495 • Number of events 2 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/1269 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.40%
2/495 • Number of events 2 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Vascular disorders
Deep vein thrombosis
|
0.24%
3/1269 • Number of events 3 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.40%
2/495 • Number of events 2 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Vascular disorders
Thrombophlebitis
|
0.08%
1/1269 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Blood and lymphatic system disorders
Agranulocytosis
|
0.08%
1/1269 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
0.08%
1/1269 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Blood and lymphatic system disorders
Febrile bone marrow aplasia
|
0.16%
2/1269 • Number of events 2 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.0%
38/1269 • Number of events 42 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.08%
1/1269 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Blood and lymphatic system disorders
Myelosuppression
|
0.16%
2/1269 • Number of events 2 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.0%
13/1269 • Number of events 14 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.08%
1/1269 • Number of events 2 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.24%
3/1269 • Number of events 3 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Cardiac disorders
Angina pectoris
|
0.08%
1/1269 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.08%
1/1269 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Cardiac disorders
Coronary artery disease
|
0.08%
1/1269 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Cardiac disorders
Sinus tachycardia
|
0.08%
1/1269 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Cardiac disorders
Tachycardia
|
0.08%
1/1269 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.08%
1/1269 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Ear and labyrinth disorders
Otolithiasis
|
0.08%
1/1269 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.16%
2/1269 • Number of events 2 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Gastrointestinal disorders
Colitis
|
0.16%
2/1269 • Number of events 2 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Gastrointestinal disorders
Constipation
|
0.16%
2/1269 • Number of events 2 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.08%
1/1269 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
0.08%
1/1269 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.16%
2/1269 • Number of events 2 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.08%
1/1269 • Number of events 2 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.08%
1/1269 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Gastrointestinal disorders
Nausea
|
0.95%
12/1269 • Number of events 12 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.08%
1/1269 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Gastrointestinal disorders
Proctitis
|
0.08%
1/1269 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.08%
1/1269 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Gastrointestinal disorders
Vomiting
|
0.79%
10/1269 • Number of events 12 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
General disorders
Asthenia
|
0.16%
2/1269 • Number of events 2 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
General disorders
Device related thrombosis
|
0.08%
1/1269 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
General disorders
Fatigue
|
0.16%
2/1269 • Number of events 2 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
General disorders
Malaise
|
0.32%
4/1269 • Number of events 6 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
General disorders
Pain
|
0.08%
1/1269 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
General disorders
Performance status decreased
|
0.08%
1/1269 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.08%
1/1269 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Hepatobiliary disorders
Jaundice
|
0.08%
1/1269 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Infections and infestations
Bacteraemia
|
0.08%
1/1269 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Infections and infestations
Bacterial abdominal infection
|
0.08%
1/1269 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Infections and infestations
Bacterial diarrhoea
|
0.08%
1/1269 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.16%
2/1269 • Number of events 2 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Infections and infestations
Device related sepsis
|
0.16%
2/1269 • Number of events 2 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Infections and infestations
Diarrhoea infectious
|
0.08%
1/1269 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Infections and infestations
Diverticulitis
|
0.08%
1/1269 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Infections and infestations
Infectious pleural effusion
|
0.16%
2/1269 • Number of events 2 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Infections and infestations
Intervertebral discitis
|
0.08%
1/1269 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.08%
1/1269 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Infections and infestations
Neutropenic sepsis
|
0.16%
2/1269 • Number of events 2 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Infections and infestations
Oral candidiasis
|
0.08%
1/1269 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Infections and infestations
Oral infection
|
0.08%
1/1269 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.08%
1/1269 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Infections and infestations
Pulmonary sepsis
|
0.08%
1/1269 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.08%
1/1269 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Infections and infestations
Stitch abscess
|
0.08%
1/1269 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.08%
1/1269 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Infections and infestations
Vascular device infection
|
0.24%
3/1269 • Number of events 3 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.08%
1/1269 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Investigations
Alanine aminotransferase increased
|
0.24%
3/1269 • Number of events 4 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Investigations
Aspartate aminotransferase increased
|
0.16%
2/1269 • Number of events 4 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Investigations
Neutrophil count decreased
|
0.71%
9/1269 • Number of events 10 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Investigations
White blood cell count decreased
|
0.32%
4/1269 • Number of events 4 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.39%
5/1269 • Number of events 5 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.16%
2/1269 • Number of events 2 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.08%
1/1269 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.16%
2/1269 • Number of events 2 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.08%
1/1269 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.08%
1/1269 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Nervous system disorders
Autonomic neuropathy
|
0.08%
1/1269 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.16%
2/1269 • Number of events 2 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Nervous system disorders
Hypotonia
|
0.08%
1/1269 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Nervous system disorders
Intercostal neuralgia
|
0.08%
1/1269 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Nervous system disorders
Seizure
|
0.08%
1/1269 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.08%
1/1269 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Product Issues
Device occlusion
|
0.08%
1/1269 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Psychiatric disorders
Catatonia
|
0.08%
1/1269 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Psychiatric disorders
Delirium
|
0.08%
1/1269 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Psychiatric disorders
Panic attack
|
0.08%
1/1269 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.08%
1/1269 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Renal and urinary disorders
Dysuria
|
0.08%
1/1269 • Number of events 2 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Renal and urinary disorders
Renal failure
|
0.24%
3/1269 • Number of events 3 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial fistula
|
0.08%
1/1269 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.08%
1/1269 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopleural fistula
|
0.08%
1/1269 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Respiratory, thoracic and mediastinal disorders
Chylothorax
|
0.08%
1/1269 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.08%
1/1269 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.16%
2/1269 • Number of events 2 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.08%
1/1269 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.16%
2/1269 • Number of events 2 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.08%
1/1269 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.08%
1/1269 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary artery thrombosis
|
0.08%
1/1269 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary granuloma
|
0.08%
1/1269 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Skin and subcutaneous tissue disorders
Subcutaneous emphysema
|
0.08%
1/1269 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Vascular disorders
Embolism
|
0.32%
4/1269 • Number of events 4 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Vascular disorders
Granulomatosis with polyangiitis
|
0.08%
1/1269 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.08%
1/1269 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Vascular disorders
Subclavian vein thrombosis
|
0.08%
1/1269 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
Other adverse events
| Measure |
Enrollment Phase
n=1269 participants at risk
All participants received up to four 21-day cycles of cisplatin-based chemotherapy (cisplatin plus either vinorelbine or docetaxel or gemcitabine or pemetrexed \[non-squamous cell NSCLC only\] based on investigator's choice), unless unacceptable toxicity, disease relapse, or participant's decision to discontinue occurred.
|
Best Supportive Care (BSC)
n=495 participants at risk
Participants who did not experience disease recurrence after chemotherapy in enrollment phase received no treatment in the randomization phase BSC arm.
|
Atezolizumab
n=495 participants at risk
Participants who did not experience disease recurrence after chemotherapy in enrollment phase received 1200 milligrams (mg) of atezolizumab intravenously (IV) every 3 weeks (Q3W) for sixteen 21-day cycles in the randomization phase.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
28.1%
357/1269 • Number of events 422 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
6.1%
30/495 • Number of events 30 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
7.5%
37/495 • Number of events 47 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Endocrine disorders
Hyperthyroidism
|
0.55%
7/1269 • Number of events 7 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.61%
3/495 • Number of events 3 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
6.7%
33/495 • Number of events 36 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Endocrine disorders
Hypothyroidism
|
0.24%
3/1269 • Number of events 3 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.61%
3/495 • Number of events 3 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
10.9%
54/495 • Number of events 61 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Gastrointestinal disorders
Diarrhoea
|
14.3%
181/1269 • Number of events 226 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
1.8%
9/495 • Number of events 12 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
7.3%
36/495 • Number of events 54 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Gastrointestinal disorders
Nausea
|
52.0%
660/1269 • Number of events 1032 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
3.2%
16/495 • Number of events 16 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
6.3%
31/495 • Number of events 44 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
General disorders
Asthenia
|
18.4%
234/1269 • Number of events 301 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
2.8%
14/495 • Number of events 15 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
7.5%
37/495 • Number of events 45 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
General disorders
Fatigue
|
21.2%
269/1269 • Number of events 309 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
2.2%
11/495 • Number of events 14 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
6.7%
33/495 • Number of events 41 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
General disorders
Pyrexia
|
5.9%
75/1269 • Number of events 86 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
2.2%
11/495 • Number of events 14 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
12.1%
60/495 • Number of events 67 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Infections and infestations
Nasopharyngitis
|
2.0%
25/1269 • Number of events 26 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
10.1%
50/495 • Number of events 65 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
6.7%
33/495 • Number of events 44 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.1%
27/1269 • Number of events 33 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
2.4%
12/495 • Number of events 14 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
7.5%
37/495 • Number of events 43 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Investigations
Alanine aminotransferase increased
|
4.1%
52/1269 • Number of events 57 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
3.2%
16/495 • Number of events 17 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
10.9%
54/495 • Number of events 71 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Investigations
Aspartate aminotransferase increased
|
3.4%
43/1269 • Number of events 47 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
3.2%
16/495 • Number of events 16 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
10.9%
54/495 • Number of events 67 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Investigations
Blood creatinine increased
|
6.7%
85/1269 • Number of events 113 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
3.0%
15/495 • Number of events 15 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
5.9%
29/495 • Number of events 36 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.8%
36/1269 • Number of events 41 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
5.3%
26/495 • Number of events 35 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
10.5%
52/495 • Number of events 65 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Nervous system disorders
Headache
|
6.1%
77/1269 • Number of events 90 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
4.0%
20/495 • Number of events 22 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
5.7%
28/495 • Number of events 39 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.3%
93/1269 • Number of events 101 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
9.3%
46/495 • Number of events 55 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
13.3%
66/495 • Number of events 84 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.0%
64/1269 • Number of events 64 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
6.5%
32/495 • Number of events 33 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
6.3%
31/495 • Number of events 35 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.7%
22/1269 • Number of events 26 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.61%
3/495 • Number of events 3 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
10.3%
51/495 • Number of events 55 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.3%
54/1269 • Number of events 58 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
1.0%
5/495 • Number of events 7 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
9.7%
48/495 • Number of events 58 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Blood and lymphatic system disorders
Leukopenia
|
6.6%
84/1269 • Number of events 128 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
1.0%
5/495 • Number of events 6 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
1.0%
5/495 • Number of events 10 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Blood and lymphatic system disorders
Neutropenia
|
26.6%
338/1269 • Number of events 568 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
1.0%
5/495 • Number of events 5 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
4.2%
21/495 • Number of events 33 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.3%
67/1269 • Number of events 94 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
1.2%
6/495 • Number of events 9 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
1.8%
9/495 • Number of events 11 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Ear and labyrinth disorders
Tinnitus
|
5.4%
69/1269 • Number of events 75 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
1.2%
6/495 • Number of events 6 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
1.2%
6/495 • Number of events 8 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
317/1269 • Number of events 389 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
1.8%
9/495 • Number of events 10 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
4.8%
24/495 • Number of events 27 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Gastrointestinal disorders
Vomiting
|
19.5%
248/1269 • Number of events 361 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
1.8%
9/495 • Number of events 9 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
4.0%
20/495 • Number of events 27 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
General disorders
Malaise
|
5.2%
66/1269 • Number of events 94 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.40%
2/495 • Number of events 2 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
1.0%
5/495 • Number of events 5 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Investigations
Neutrophil count decreased
|
14.7%
187/1269 • Number of events 367 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.61%
3/495 • Number of events 3 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
1.8%
9/495 • Number of events 10 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Investigations
Platelet count decreased
|
5.8%
73/1269 • Number of events 108 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
2.0%
10/495 • Number of events 12 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Investigations
White blood cell count decreased
|
8.7%
111/1269 • Number of events 221 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
1.2%
6/495 • Number of events 7 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
24.0%
305/1269 • Number of events 421 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
1.4%
7/495 • Number of events 7 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
4.6%
23/495 • Number of events 28 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Nervous system disorders
Dizziness
|
5.5%
70/1269 • Number of events 74 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
3.0%
15/495 • Number of events 15 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
3.6%
18/495 • Number of events 20 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Nervous system disorders
Dysgeusia
|
7.5%
95/1269 • Number of events 106 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.20%
1/495 • Number of events 1 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.40%
2/495 • Number of events 2 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Psychiatric disorders
Insomnia
|
5.9%
75/1269 • Number of events 80 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
1.2%
6/495 • Number of events 6 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
4.2%
21/495 • Number of events 21 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
7.0%
89/1269 • Number of events 142 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
0.00%
0/495 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
14.3%
181/1269 • Number of events 183 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
2.0%
10/495 • Number of events 10 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
1.2%
6/495 • Number of events 6 • Up to 95 months
Enrolled safety-evaluable population included patients in enrollment phase \& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \& randomized patients who were randomized to control arm \& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.
|
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