Trial Outcomes & Findings for A Phase III, Open-Label Study of Maintenance Lurbinectedin in Combination With Atezolizumab Compared With Atezolizumab in Participants With Extensive-Stage Small-Cell Lung Cancer (NCT NCT05091567)
NCT ID: NCT05091567
Last Updated: 2025-12-29
Results Overview
PFS was defined as the time from randomization to the date of first documented PD as determined by the IRF according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or death, whichever occurs first. PD was defined as appearance of a new lesion(s), unequivocal progression in non-target lesion(s) or at least a 20% increase in the sum of diameters (SOD) of target lesions, taking as reference the smallest sum on the study including baseline (nadir). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimetres (mm).
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
660 participants
Primary outcome timeframe
Up to 26 months
Results posted on
2025-12-29
Participant Flow
A total of 660 participants with ES SCLC took part in the study across 96 investigative sites in 13 countries.
The study consists of 2 phases, an enrollment phase (induction phase), where participants received standard of care treatment with carboplatin, etoposide and atezolizumab, and a randomized phase (maintenance phase), where participants were randomized in 1:1 ratio to receive either atezolizumab + lurbinectedin or atezolizumab. The study is ongoing.
Participant milestones
| Measure |
Atezolizumab + Carboplatin + Etoposide
Participants received atezolizumab, 1200 milligrams (mg), every 3 weeks (Q3W) as intravenous (IV) infusion on Day 1 of each 21-day cycle in combination with carboplatin on Day 1 and etoposide, in accordance with local standard of care, on Days 1, 2, and 3 of each cycle for up to 4 cycles.
|
Atezolizumab
Participants received atezolizumab, 1200 mg, Q3W as IV infusion on Day 1 of each 21-day cycle until unacceptable toxicity or disease progression (PD) whichever occurred first.
|
Atezolizumab+ Lurbinectedin
Participants received atezolizumab, 1200 mg, Q3W as IV infusion and lurbinectedin, 3.2 milligrams per square meter (mg/m\^2), Q3W as IV infusion on Day 1 of each 21-day cycle until unacceptable toxicity or PD whichever occurred first.
|
|---|---|---|---|
|
Enrollment Phase
STARTED
|
660
|
0
|
0
|
|
Enrollment Phase
Enrolled Safety Analysis Set (SAS)
|
653
|
0
|
0
|
|
Enrollment Phase
COMPLETED
|
571
|
0
|
0
|
|
Enrollment Phase
NOT COMPLETED
|
89
|
0
|
0
|
|
Randomized Phase
STARTED
|
0
|
241
|
242
|
|
Randomized Phase
SAS
|
0
|
240
|
242
|
|
Randomized Phase
COMPLETED
|
0
|
0
|
0
|
|
Randomized Phase
NOT COMPLETED
|
0
|
241
|
242
|
Reasons for withdrawal
| Measure |
Atezolizumab + Carboplatin + Etoposide
Participants received atezolizumab, 1200 milligrams (mg), every 3 weeks (Q3W) as intravenous (IV) infusion on Day 1 of each 21-day cycle in combination with carboplatin on Day 1 and etoposide, in accordance with local standard of care, on Days 1, 2, and 3 of each cycle for up to 4 cycles.
|
Atezolizumab
Participants received atezolizumab, 1200 mg, Q3W as IV infusion on Day 1 of each 21-day cycle until unacceptable toxicity or disease progression (PD) whichever occurred first.
|
Atezolizumab+ Lurbinectedin
Participants received atezolizumab, 1200 mg, Q3W as IV infusion and lurbinectedin, 3.2 milligrams per square meter (mg/m\^2), Q3W as IV infusion on Day 1 of each 21-day cycle until unacceptable toxicity or PD whichever occurred first.
|
|---|---|---|---|
|
Enrollment Phase
Death
|
37
|
0
|
0
|
|
Enrollment Phase
Adverse Event
|
21
|
0
|
0
|
|
Enrollment Phase
Progressive Disease
|
10
|
0
|
0
|
|
Enrollment Phase
Withdrawal by Subject
|
8
|
0
|
0
|
|
Enrollment Phase
Symptomatic Deterioration
|
7
|
0
|
0
|
|
Enrollment Phase
Physician Decision
|
3
|
0
|
0
|
|
Enrollment Phase
Protocol Violation
|
2
|
0
|
0
|
|
Enrollment Phase
Reason not Specified
|
1
|
0
|
0
|
|
Randomized Phase
Death
|
0
|
135
|
112
|
|
Randomized Phase
Progressive Disease
|
0
|
2
|
0
|
|
Randomized Phase
Withdrawal by Subject
|
0
|
1
|
3
|
|
Randomized Phase
Lost to Follow-up
|
0
|
1
|
1
|
|
Randomized Phase
Ongoing in Study
|
0
|
102
|
126
|
Baseline Characteristics
A Phase III, Open-Label Study of Maintenance Lurbinectedin in Combination With Atezolizumab Compared With Atezolizumab in Participants With Extensive-Stage Small-Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Atezolizumab
n=241 Participants
Participants received atezolizumab, 1200 mg, Q3W as IV infusion on Day 1 of each 21-day cycle until unacceptable toxicity or PD whichever occurred first.
|
Atezolizumab+ Lurbinectedin
n=242 Participants
Participants received atezolizumab, 1200 mg, Q3W, as IV infusion and lurbinectedin, 3.2 mg/m\^2, Q3W, as IV infusion on Day 1 of each 21-day cycle until unacceptable toxicity or PD whichever occurred first.
|
Total
n=483 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.0 years
STANDARD_DEVIATION 8.0 • n=174 Participants
|
65.1 years
STANDARD_DEVIATION 7.6 • n=166 Participants
|
65.5 years
STANDARD_DEVIATION 7.8 • n=167 Participants
|
|
Sex: Female, Male
Female
|
90 Participants
n=174 Participants
|
91 Participants
n=166 Participants
|
181 Participants
n=167 Participants
|
|
Sex: Female, Male
Male
|
151 Participants
n=174 Participants
|
151 Participants
n=166 Participants
|
302 Participants
n=167 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=174 Participants
|
16 Participants
n=166 Participants
|
32 Participants
n=167 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
210 Participants
n=174 Participants
|
206 Participants
n=166 Participants
|
416 Participants
n=167 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
15 Participants
n=174 Participants
|
20 Participants
n=166 Participants
|
35 Participants
n=167 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=174 Participants
|
1 Participants
n=166 Participants
|
1 Participants
n=167 Participants
|
|
Race (NIH/OMB)
Asian
|
31 Participants
n=174 Participants
|
31 Participants
n=166 Participants
|
62 Participants
n=167 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=174 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=174 Participants
|
3 Participants
n=166 Participants
|
4 Participants
n=167 Participants
|
|
Race (NIH/OMB)
White
|
199 Participants
n=174 Participants
|
195 Participants
n=166 Participants
|
394 Participants
n=167 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=174 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=174 Participants
|
12 Participants
n=166 Participants
|
22 Participants
n=167 Participants
|
PRIMARY outcome
Timeframe: Up to 26 monthsPopulation: FAS included all participants randomized into the randomized phase, regardless of whether or not the assigned study treatment was received.
PFS was defined as the time from randomization to the date of first documented PD as determined by the IRF according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or death, whichever occurs first. PD was defined as appearance of a new lesion(s), unequivocal progression in non-target lesion(s) or at least a 20% increase in the sum of diameters (SOD) of target lesions, taking as reference the smallest sum on the study including baseline (nadir). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimetres (mm).
Outcome measures
| Measure |
Atezolizumab
n=241 Participants
Participants received atezolizumab, 1200 mg, Q3W as IV infusion on Day 1 of each 21-day cycle until unacceptable toxicity or PD whichever occurred first.
|
Atezolizumab+ Lurbinectedin
n=242 Participants
Participants received atezolizumab, 1200 mg, Q3W, as IV infusion and lurbinectedin, 3.2 mg/m\^2, Q3W, as IV infusion on Day 1 of each 21-day cycle until unacceptable toxicity or PD whichever occurred first.
|
|---|---|---|
|
Randomized Phase: Independent Review Facility (IRF) - Assessed Progression Free Survival (PFS)
|
2.14 months
95% Confidence Interval 1.64 • Interval 1.64 to 2.73
|
5.36 months
95% Confidence Interval 4.24 • Interval 4.24 to 5.75
|
PRIMARY outcome
Timeframe: Up to 26 monthsPopulation: FAS included all participants randomized into the randomized phase, regardless of whether or not the assigned study treatment was received.
OS was defined as the time from randomization to the date of death from any cause.
Outcome measures
| Measure |
Atezolizumab
n=241 Participants
Participants received atezolizumab, 1200 mg, Q3W as IV infusion on Day 1 of each 21-day cycle until unacceptable toxicity or PD whichever occurred first.
|
Atezolizumab+ Lurbinectedin
n=242 Participants
Participants received atezolizumab, 1200 mg, Q3W, as IV infusion and lurbinectedin, 3.2 mg/m\^2, Q3W, as IV infusion on Day 1 of each 21-day cycle until unacceptable toxicity or PD whichever occurred first.
|
|---|---|---|
|
Randomized Phase: Overall Survival (OS)
|
10.64 months
95% Confidence Interval 9.49 • Interval 9.49 to 12.16
|
13.24 months
95% Confidence Interval 11.89 • Interval 11.89 to 16.36
|
SECONDARY outcome
Timeframe: Up to 26 monthsPopulation: FAS included all participants randomized into the randomized phase, regardless of whether or not the assigned study treatment was received.
PFS was defined as the time from randomization to the date of first documented PD as assessed by investigator according to RECIST v1.1 or death, whichever occurs first. PD was defined as appearance of a new lesion(s), unequivocal progression in non-target lesion(s) or at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on the study including baseline (nadir). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Outcome measures
| Measure |
Atezolizumab
n=241 Participants
Participants received atezolizumab, 1200 mg, Q3W as IV infusion on Day 1 of each 21-day cycle until unacceptable toxicity or PD whichever occurred first.
|
Atezolizumab+ Lurbinectedin
n=242 Participants
Participants received atezolizumab, 1200 mg, Q3W, as IV infusion and lurbinectedin, 3.2 mg/m\^2, Q3W, as IV infusion on Day 1 of each 21-day cycle until unacceptable toxicity or PD whichever occurred first.
|
|---|---|---|
|
Randomized Phase: Investigator-assessed PFS
|
2.73 months
95% Confidence Interval 2.53 • Interval 2.53 to 2.83
|
5.36 months
95% Confidence Interval 4.30 • Interval 4.3 to 6.57
|
SECONDARY outcome
Timeframe: Up to 26 monthsPopulation: FAS included all participants randomized into the randomized phase, regardless of whether or not the assigned study treatment was received. Overall number analyzed is the number of participants with measurable disease at baseline, as assessed by IRF.
ORR was defined as the percentage of participants with an objective tumor response of complete response (CR) or partial response (PR) as determined by the IRF using RECIST v.1.1. CR was defined as the disappearance of all target and non-target lesions or any pathological lymph nodes (whether target or non-target) have a reduction in short axis to \< 10 mm. PR was defined as at least a 30% decrease in the sum of diameters (SOD) of target lesions, taking as reference the baseline SOD. Percentages have been rounded off.
Outcome measures
| Measure |
Atezolizumab
n=182 Participants
Participants received atezolizumab, 1200 mg, Q3W as IV infusion on Day 1 of each 21-day cycle until unacceptable toxicity or PD whichever occurred first.
|
Atezolizumab+ Lurbinectedin
n=175 Participants
Participants received atezolizumab, 1200 mg, Q3W, as IV infusion and lurbinectedin, 3.2 mg/m\^2, Q3W, as IV infusion on Day 1 of each 21-day cycle until unacceptable toxicity or PD whichever occurred first.
|
|---|---|---|
|
Randomized Phase: Confirmed Objective Response Rate (ORR) as Determined by the IRF
|
10.4 percentage of participants
95% Confidence Interval 6.40 • Interval 6.4 to 15.82
|
19.4 percentage of participants
95% Confidence Interval 13.85 • Interval 13.85 to 26.08
|
SECONDARY outcome
Timeframe: Up to 26 monthsPopulation: FAS included all participants randomized into the randomized phase, regardless of whether or not the assigned study treatment was received. Overall number analyzed is the number of participants with measurable disease at baseline, as assessed by investigator.
ORR was defined as the percentage of participants with an objective tumor response of CR or PR as determined by the investigator using RECIST v.1.1. CR was defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) have a reduction in short axis to \< 10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD.
Outcome measures
| Measure |
Atezolizumab
n=205 Participants
Participants received atezolizumab, 1200 mg, Q3W as IV infusion on Day 1 of each 21-day cycle until unacceptable toxicity or PD whichever occurred first.
|
Atezolizumab+ Lurbinectedin
n=205 Participants
Participants received atezolizumab, 1200 mg, Q3W, as IV infusion and lurbinectedin, 3.2 mg/m\^2, Q3W, as IV infusion on Day 1 of each 21-day cycle until unacceptable toxicity or PD whichever occurred first.
|
|---|---|---|
|
Randomized Phase: Confirmed ORR as Determined by the Investigator
|
13.2 percentage of participants
95% Confidence Interval 8.86 • Interval 8.86 to 18.58
|
17.1 percentage of participants
95% Confidence Interval 12.19 • Interval 12.19 to 22.94
|
SECONDARY outcome
Timeframe: Up to 26 monthsPopulation: FAS included all participants randomized into the randomized phase, regardless of whether or not the assigned study treatment was received. Overall number analyzed is the number of participants with response, per IRF.
DOR was calculated for participants who had a best confirmed OR of CR/PR. DOR= time from first occurrence of a documented OR until the time of documented PD as determined by IRF assessment using RECIST v1.1 or death from any cause, whichever occurs first. CR=disappearance of all target and non-target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in short axis to \<10 mm. PR= at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. PD was defined as appearance of a new lesion(s), unequivocal progression in non-target lesion(s) or at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on the study including baseline (nadir). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Outcome measures
| Measure |
Atezolizumab
n=19 Participants
Participants received atezolizumab, 1200 mg, Q3W as IV infusion on Day 1 of each 21-day cycle until unacceptable toxicity or PD whichever occurred first.
|
Atezolizumab+ Lurbinectedin
n=34 Participants
Participants received atezolizumab, 1200 mg, Q3W, as IV infusion and lurbinectedin, 3.2 mg/m\^2, Q3W, as IV infusion on Day 1 of each 21-day cycle until unacceptable toxicity or PD whichever occurred first.
|
|---|---|---|
|
Randomized Phase: Duration of Response (DOR) as Determined by the IRF
|
5.62 months
Interval 4.17 to
Upper limit of 95 %Cl was not estimable due to insufficient number of participants with events.
|
9.00 months
Interval 5.52 to
Upper limit of 95 %Cl was not estimable due to insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Up to 26 monthsPopulation: FAS included all participants randomized into the randomized phase, regardless of whether or not the assigned study treatment was received. Overall number analyzed is the number of participants with response, per investigator.
DOR was calculated for participants who had a best confirmed OR of CR/PR. DOR= time from first occurrence of a documented OR until the time of documented PD as determined by investigator using RECIST v1.1 or death from any cause, whichever occurs first. CR=disappearance of all target and non-target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in short axis to \<10 mm. PR= at least a 30% decrease in the SOD of target lesions, taking as reference the baseline SOD. PD was defined as appearance of a new lesion(s), unequivocal progression in non-target lesion(s) or at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on the study including baseline (nadir). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Outcome measures
| Measure |
Atezolizumab
n=27 Participants
Participants received atezolizumab, 1200 mg, Q3W as IV infusion on Day 1 of each 21-day cycle until unacceptable toxicity or PD whichever occurred first.
|
Atezolizumab+ Lurbinectedin
n=35 Participants
Participants received atezolizumab, 1200 mg, Q3W, as IV infusion and lurbinectedin, 3.2 mg/m\^2, Q3W, as IV infusion on Day 1 of each 21-day cycle until unacceptable toxicity or PD whichever occurred first.
|
|---|---|---|
|
Randomized Phase: DOR as Determined by the Investigator
|
11.93 months
Interval 8.38 to
Upper limit of 95 %Cl was not estimable due to insufficient number of participants with events.
|
5.75 months
Interval 4.17 to 11.1
|
SECONDARY outcome
Timeframe: Months 6 and 12Population: FAS included all participants randomized into the randomized phase, regardless of whether or not the assigned study treatment was received.
PFS rate at 6 months and 12 months was defined as the percentage of participants who had not experienced PD as determined by the IRF according to RECIST v1.1 or death from any cause at 6 months and 12 months after randomization. PD was defined as appearance of a new lesion(s), unequivocal progression in non-target lesion(s) or at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on the study including baseline (nadir). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Percentages have been rounded off.
Outcome measures
| Measure |
Atezolizumab
n=241 Participants
Participants received atezolizumab, 1200 mg, Q3W as IV infusion on Day 1 of each 21-day cycle until unacceptable toxicity or PD whichever occurred first.
|
Atezolizumab+ Lurbinectedin
n=242 Participants
Participants received atezolizumab, 1200 mg, Q3W, as IV infusion and lurbinectedin, 3.2 mg/m\^2, Q3W, as IV infusion on Day 1 of each 21-day cycle until unacceptable toxicity or PD whichever occurred first.
|
|---|---|---|
|
Randomized Phase: Percentage of Participants With PFS as Determined by the IRF at 6 Months and 12 Months
6 Months
|
18.66 percentage of participants
95% Confidence Interval 13.45 • Interval 13.45 to 23.87
|
41.22 percentage of participants
95% Confidence Interval 34.58 • Interval 34.58 to 47.86
|
|
Randomized Phase: Percentage of Participants With PFS as Determined by the IRF at 6 Months and 12 Months
12 Months
|
12.03 percentage of participants
95% Confidence Interval 7.27 • Interval 7.27 to 16.8
|
20.54 percentage of participants
95% Confidence Interval 14.37 • Interval 14.37 to 26.72
|
SECONDARY outcome
Timeframe: Months 6 and 12Population: FAS included all participants randomized into the randomized phase, regardless of whether or not the assigned study treatment was received.
PFS rate at 6 months and 12 months was defined as the percentage of participants who had not experienced PD as determined by the investigator according to RECIST v1.1 or death from any cause at 6 months and 12 months after randomization. PD was defined as appearance of a new lesion(s), unequivocal progression in non-target lesion(s) or at least a 20% increase in the SOD of target lesions, taking as reference the smallest sum on the study including baseline (nadir). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Percentages have been rounded off.
Outcome measures
| Measure |
Atezolizumab
n=241 Participants
Participants received atezolizumab, 1200 mg, Q3W as IV infusion on Day 1 of each 21-day cycle until unacceptable toxicity or PD whichever occurred first.
|
Atezolizumab+ Lurbinectedin
n=242 Participants
Participants received atezolizumab, 1200 mg, Q3W, as IV infusion and lurbinectedin, 3.2 mg/m\^2, Q3W, as IV infusion on Day 1 of each 21-day cycle until unacceptable toxicity or PD whichever occurred first.
|
|---|---|---|
|
Randomized Phase: Percentage of Participants With PFS Determined by Investigator at 6 Months and 12 Months
6 Months
|
22.56 percentage of participants
95% Confidence Interval 17.12 • Interval 17.12 to 28.0
|
46.21 percentage of participants
95% Confidence Interval 39.60 • Interval 39.6 to 52.81
|
|
Randomized Phase: Percentage of Participants With PFS Determined by Investigator at 6 Months and 12 Months
12 Months
|
12.80 percentage of participants
95% Confidence Interval 8.07 • Interval 8.07 to 17.52
|
20.32 percentage of participants
95% Confidence Interval 14.33 • Interval 14.33 to 26.32
|
SECONDARY outcome
Timeframe: Months 12 and 24OS rate at 12 months and 24 months was defined as the percentage of participants who had not experienced death from any cause at 12 months and 24 months after randomization. Percentages have been rounded off.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 26 monthsPopulation: Saftey analysis set (SAS)=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
An AE =any unfavorable \& unintended sign (including abnormal laboratory values/abnormal clinical test results), symptoms/disease temporally associated with the use of a pharmaceutical product, whether considered related to the pharmaceutical product. SAE=any significant hazard, contraindication, side effect that is fatal or life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is medically significant or requires intervention to prevent one or other of the outcomes listed above. AESI= drug induced liver injury, suspected transmission of infectious agent via study treatment, hepatitis, systemic lupus erythematosus, hypersensitivity, etc. AESIs may include events not specified in the protocol.
Outcome measures
| Measure |
Atezolizumab
n=240 Participants
Participants received atezolizumab, 1200 mg, Q3W as IV infusion on Day 1 of each 21-day cycle until unacceptable toxicity or PD whichever occurred first.
|
Atezolizumab+ Lurbinectedin
n=242 Participants
Participants received atezolizumab, 1200 mg, Q3W, as IV infusion and lurbinectedin, 3.2 mg/m\^2, Q3W, as IV infusion on Day 1 of each 21-day cycle until unacceptable toxicity or PD whichever occurred first.
|
|---|---|---|
|
Randomized Phase: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)
AEs
|
194 Participants
|
235 Participants
|
|
Randomized Phase: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)
AESIs for Atezolizumab
|
54 Participants
|
76 Participants
|
|
Randomized Phase: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)
AESIs for Lurbinectedin
|
62 Participants
|
93 Participants
|
|
Randomized Phase: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)
SAEs
|
41 Participants
|
75 Participants
|
SECONDARY outcome
Timeframe: Up to 26 monthsPopulation: ADA-evaluable population was defined as participants with at least one post-dose evaluable ADA sample (collected in the randomized phase).
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 at least one positive post-baseline ADA result during the randomized phase, 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 |
Atezolizumab
n=239 Participants
Participants received atezolizumab, 1200 mg, Q3W as IV infusion on Day 1 of each 21-day cycle until unacceptable toxicity or PD whichever occurred first.
|
Atezolizumab+ Lurbinectedin
n=242 Participants
Participants received atezolizumab, 1200 mg, Q3W, as IV infusion and lurbinectedin, 3.2 mg/m\^2, Q3W, as IV infusion on Day 1 of each 21-day cycle until unacceptable toxicity or PD whichever occurred first.
|
|---|---|---|
|
Randomized Phase: Number of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab
|
20 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: Up to 26 monthsPopulation: FAS included all participants randomized into the randomized phase, regardless of whether or not the assigned study treatment was received.
EORTC QLQ-C30=30 questions assessing 5 aspects of participant functioning(physical,emotional,role,cognitive \&social),3 symptom scales,GHS/QoL \& 6 single items.PF scale=5 questions about participants PF \& daily activities(strenuous activities,long walks,short walks,bed/chair rest \& needing help with eating,dressing,washing themselves/using the toilet).PF scale scored on 4-point scale(1=Not at All-4=Very Much).GHS/QoL scored on 7-point scale(1=Very Poor- 7=Excellent).Scores were linearly transformed to a range of 0-100,higher scores=higher response level \& better QoL.TTCD for PF \& GHS/QoL=time from the date of randomization until first confirmed clinically meaningful deterioration,which is decrease from baseline in PF/GHS score that must be held for at least 2 consecutive assessments/initial decrease above baseline followed by death attributable to cancer progression within 6 weeks of the last deteriorated assessment.Score change≥10-point change in subscale score,considered meaningful.
Outcome measures
| Measure |
Atezolizumab
n=241 Participants
Participants received atezolizumab, 1200 mg, Q3W as IV infusion on Day 1 of each 21-day cycle until unacceptable toxicity or PD whichever occurred first.
|
Atezolizumab+ Lurbinectedin
n=242 Participants
Participants received atezolizumab, 1200 mg, Q3W, as IV infusion and lurbinectedin, 3.2 mg/m\^2, Q3W, as IV infusion on Day 1 of each 21-day cycle until unacceptable toxicity or PD whichever occurred first.
|
|---|---|---|
|
Randomized Phase: Time to Confirmed Deterioration (TTCD) in Physical Functioning (PF) and Global Health Status (GHS) as Measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQC30)
TTCD for PF
|
NA months
Percentage and 95 %Cl was not estimable due to insufficient number of participants with events.
|
15.9 months
Interval 11.0 to
Upper limit of 95 %Cl was not estimable due to insufficient number of participants with events.
|
|
Randomized Phase: Time to Confirmed Deterioration (TTCD) in Physical Functioning (PF) and Global Health Status (GHS) as Measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQC30)
TTCD for GHS/QoL
|
12.9 months
Interval 11.6 to
Upper limit of 95 %Cl was not estimable due to insufficient number of participants with events.
|
10.8 months
Interval 7.6 to
Upper limit of 95 %Cl was not estimable due to insufficient number of participants with events.
|
Adverse Events
Atezolizumab + Carboplatin + Etoposide
Serious events: 181 serious events
Other events: 526 other events
Deaths: 54 deaths
Atezolizumab
Serious events: 41 serious events
Other events: 127 other events
Deaths: 135 deaths
Atezolizumab+ Lurbinectedin
Serious events: 75 serious events
Other events: 213 other events
Deaths: 113 deaths
Serious adverse events
| Measure |
Atezolizumab + Carboplatin + Etoposide
n=653 participants at risk
Participants received atezolizumab, 1200 mg, Q3W as IV infusion on Day 1 of each 21-day cycle in combination with carboplatin on Day 1 and etoposide, in accordance with local standard of care, on Days 1, 2, and 3 of each cycle for up to 4 cycles.
|
Atezolizumab
n=240 participants at risk
Participants received atezolizumab, 1200 mg, Q3W as IV infusion on Day 1 of each 21-day cycle until unacceptable toxicity or PD whichever occurred first.
|
Atezolizumab+ Lurbinectedin
n=242 participants at risk
Participants received atezolizumab, 1200 mg, Q3W, as IV infusion and lurbinectedin, 3.2 mg/m\^2, Q3W, as IV infusion on Day 1 of each 21-day cycle until unacceptable toxicity or PD whichever occurred first.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.31%
2/653 • Number of events 2 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.15%
1/653 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.15%
1/653 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/653 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.41%
1/242 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.31%
2/653 • Number of events 2 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.15%
1/653 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/653 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.42%
1/240 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Injury, poisoning and procedural complications
Fall
|
0.15%
1/653 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.41%
1/242 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/653 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.42%
1/240 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Injury, poisoning and procedural complications
Epidural haemorrhage
|
0.15%
1/653 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Skin and subcutaneous tissue disorders
Panniculitis
|
0.00%
0/653 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.41%
1/242 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/653 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.42%
1/240 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Endocrine disorders
Hyperthyroidism
|
0.15%
1/653 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.15%
1/653 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Endocrine disorders
Hypothyroidism
|
0.15%
1/653 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Infections and infestations
Pneumonia
|
3.4%
22/653 • Number of events 24 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
2.5%
6/240 • Number of events 6 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
2.5%
6/242 • Number of events 6 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/653 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.41%
1/242 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Infections and infestations
Gastrointestinal infection
|
0.15%
1/653 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Infections and infestations
Otitis externa
|
0.15%
1/653 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.15%
1/653 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/653 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.41%
1/242 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Infections and infestations
Lung abscess
|
0.15%
1/653 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Infections and infestations
Vascular access site infection
|
0.15%
1/653 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Infections and infestations
COVID-19
|
1.2%
8/653 • Number of events 8 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.42%
1/240 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.83%
2/242 • Number of events 2 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Infections and infestations
Urinary tract infection
|
0.31%
2/653 • Number of events 2 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.42%
1/240 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.41%
1/242 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.00%
0/653 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.41%
1/242 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Infections and infestations
Vascular device infection
|
0.15%
1/653 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.83%
2/242 • Number of events 2 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Infections and infestations
Bacteroides infection
|
0.00%
0/653 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.42%
1/240 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Infections and infestations
Respiratory tract infection
|
0.46%
3/653 • Number of events 3 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.42%
1/240 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
2.1%
5/242 • Number of events 5 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.15%
1/653 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.41%
1/242 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.15%
1/653 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.42%
1/240 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.83%
2/242 • Number of events 2 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Infections and infestations
Encephalitis
|
0.00%
0/653 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.42%
1/240 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.15%
1/653 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Infections and infestations
Septic shock
|
0.46%
3/653 • Number of events 3 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.41%
1/242 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Infections and infestations
Febrile infection
|
0.00%
0/653 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.41%
1/242 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Infections and infestations
Neutropenic sepsis
|
0.77%
5/653 • Number of events 5 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Infections and infestations
Infection
|
0.00%
0/653 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
1.2%
3/242 • Number of events 3 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Infections and infestations
Neutropenic infection
|
0.15%
1/653 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Infections and infestations
Pneumonia aspiration
|
0.31%
2/653 • Number of events 2 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Infections and infestations
Sepsis
|
1.7%
11/653 • Number of events 11 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.42%
1/240 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.41%
1/242 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Infections and infestations
Abscess intestinal
|
0.00%
0/653 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.42%
1/240 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/653 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.42%
1/240 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Infections and infestations
Infectious pleural effusion
|
0.15%
1/653 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Infections and infestations
Bursitis infective
|
0.00%
0/653 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.42%
1/240 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Metabolism and nutrition disorders
Hyperamylasaemia
|
0.15%
1/653 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.8%
12/653 • Number of events 13 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
1.2%
3/240 • Number of events 3 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.83%
2/242 • Number of events 6 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.31%
2/653 • Number of events 2 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.15%
1/653 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.15%
1/653 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.41%
1/242 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.15%
1/653 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.15%
1/653 • Number of events 2 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.15%
1/653 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/653 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.41%
1/242 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.15%
1/653 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Metabolism and nutrition disorders
Alkalosis
|
0.00%
0/653 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.41%
1/242 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.15%
1/653 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.15%
1/653 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/653 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.41%
1/242 • Number of events 3 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Vascular disorders
Superior vena cava syndrome
|
0.15%
1/653 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.41%
1/242 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/653 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.41%
1/242 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Vascular disorders
Thrombosis
|
0.31%
2/653 • Number of events 2 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.41%
1/242 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Vascular disorders
Embolism
|
0.61%
4/653 • Number of events 4 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/653 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.41%
1/242 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/653 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.41%
1/242 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Investigations
Neutrophil count decreased
|
0.77%
5/653 • Number of events 5 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.83%
2/242 • Number of events 2 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Investigations
Platelet count decreased
|
0.61%
4/653 • Number of events 4 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
2.1%
5/242 • Number of events 6 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Investigations
Aspartate aminotransferase increased
|
0.15%
1/653 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.41%
1/242 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Investigations
White blood cell count decreased
|
0.61%
4/653 • Number of events 4 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.41%
1/242 • Number of events 2 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/653 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.41%
1/242 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.15%
1/653 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.42%
1/240 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Cardiac disorders
Myocardial infarction
|
0.31%
2/653 • Number of events 2 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
1.2%
3/242 • Number of events 3 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.15%
1/653 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Cardiac disorders
Atrial fibrillation
|
0.31%
2/653 • Number of events 2 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.41%
1/242 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/653 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.42%
1/240 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.83%
2/242 • Number of events 2 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Cardiac disorders
Cardiac arrest
|
0.15%
1/653 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.15%
1/653 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.41%
1/242 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Cardiac disorders
Angina pectoris
|
0.15%
1/653 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.15%
1/653 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/653 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.41%
1/242 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
General disorders
General physical health deterioration
|
0.46%
3/653 • Number of events 3 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
General disorders
Asthenia
|
0.31%
2/653 • Number of events 2 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
General disorders
Pain
|
0.00%
0/653 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.41%
1/242 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
General disorders
Sudden death
|
0.15%
1/653 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
General disorders
Chest pain
|
0.00%
0/653 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.42%
1/240 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.41%
1/242 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
General disorders
Pyrexia
|
0.31%
2/653 • Number of events 2 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
1.2%
3/242 • Number of events 3 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
General disorders
Death
|
0.00%
0/653 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.42%
1/240 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
General disorders
Fatigue
|
0.31%
2/653 • Number of events 2 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.41%
1/242 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
General disorders
Administration site extravasation
|
0.00%
0/653 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.41%
1/242 • Number of events 2 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
General disorders
Oedema peripheral
|
0.00%
0/653 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.41%
1/242 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
General disorders
Sudden cardiac death
|
0.46%
3/653 • Number of events 3 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
General disorders
Adhesion
|
0.00%
0/653 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.42%
1/240 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Renal and urinary disorders
Perinephric collection
|
0.00%
0/653 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.41%
1/242 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Renal and urinary disorders
Nephropathy
|
0.00%
0/653 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.41%
1/242 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.31%
2/653 • Number of events 2 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.41%
1/242 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/653 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.83%
2/242 • Number of events 2 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Renal and urinary disorders
Immune-mediated nephritis
|
0.00%
0/653 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.83%
2/242 • Number of events 2 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Renal and urinary disorders
Haematuria
|
0.31%
2/653 • Number of events 2 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.15%
1/653 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Renal and urinary disorders
Nocturia
|
0.15%
1/653 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Respiratory, thoracic and mediastinal disorders
Lower respiratory tract inflammation
|
0.15%
1/653 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.31%
2/653 • Number of events 2 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.46%
3/653 • Number of events 3 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.42%
1/240 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.83%
2/242 • Number of events 2 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.15%
1/653 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.41%
1/242 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea at rest
|
0.15%
1/653 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/653 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.41%
1/242 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/653 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.42%
1/240 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Respiratory, thoracic and mediastinal disorders
Immune-mediated lung disease
|
0.00%
0/653 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.41%
1/242 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.15%
1/653 • Number of events 2 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.83%
2/242 • Number of events 2 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.31%
2/653 • Number of events 2 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
1.7%
4/240 • Number of events 5 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
2.1%
5/242 • Number of events 5 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/653 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.83%
2/242 • Number of events 2 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/653 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.42%
1/240 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.15%
1/653 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.83%
2/242 • Number of events 2 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.15%
1/653 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.31%
2/653 • Number of events 2 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.77%
5/653 • Number of events 6 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.83%
2/242 • Number of events 2 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Blood and lymphatic system disorders
Anaemia
|
3.8%
25/653 • Number of events 31 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.83%
2/242 • Number of events 2 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Blood and lymphatic system disorders
Haematotoxicity
|
0.15%
1/653 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/653 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.41%
1/242 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/653 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.42%
1/240 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.4%
22/653 • Number of events 23 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
1.7%
4/242 • Number of events 4 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.2%
8/653 • Number of events 8 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Hepatobiliary disorders
Hepatitis
|
0.15%
1/653 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
0.00%
0/653 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.41%
1/242 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/653 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.41%
1/242 • Number of events 2 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Gastrointestinal disorders
Volvulus
|
0.00%
0/653 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.42%
1/240 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.41%
1/242 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.00%
0/653 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.42%
1/240 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.15%
1/653 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.41%
1/242 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/653 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.42%
1/240 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/653 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.42%
1/240 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.83%
2/242 • Number of events 3 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.15%
1/653 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.42%
1/240 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Gastrointestinal disorders
Subileus
|
0.15%
1/653 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Gastrointestinal disorders
Vomiting
|
0.31%
2/653 • Number of events 2 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Gastrointestinal disorders
Ileus
|
0.15%
1/653 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.41%
1/242 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/653 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.41%
1/242 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.77%
5/653 • Number of events 5 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Gastrointestinal disorders
Enteritis
|
0.15%
1/653 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Gastrointestinal disorders
Gastrointestinal polyp haemorrhage
|
0.00%
0/653 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.42%
1/240 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Gastrointestinal disorders
Colitis
|
0.61%
4/653 • Number of events 4 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.83%
2/240 • Number of events 2 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.41%
1/242 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Gastrointestinal disorders
Ascites
|
0.15%
1/653 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/653 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.42%
1/240 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/653 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.83%
2/240 • Number of events 2 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.83%
2/242 • Number of events 2 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Nervous system disorders
Dizziness
|
0.15%
1/653 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.41%
1/242 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Nervous system disorders
Syncope
|
0.00%
0/653 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.83%
2/242 • Number of events 2 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Nervous system disorders
Spinal cord compression
|
0.15%
1/653 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.42%
1/240 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/653 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.42%
1/240 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.41%
1/242 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/653 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.42%
1/240 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Nervous system disorders
Myelitis transverse
|
0.15%
1/653 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/653 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.42%
1/240 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.41%
1/242 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Nervous system disorders
Altered state of consciousness
|
0.15%
1/653 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Nervous system disorders
Hypoaesthesia
|
0.15%
1/653 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Nervous system disorders
Seizure
|
0.31%
2/653 • Number of events 3 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.42%
1/240 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.41%
1/242 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Nervous system disorders
Polyneuropathy
|
0.15%
1/653 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.00%
0/653 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.41%
1/242 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/653 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.42%
1/240 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.15%
1/653 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/653 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.83%
2/242 • Number of events 2 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
0.00%
0/653 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.42%
1/240 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/653 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.41%
1/242 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.15%
1/653 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.41%
1/242 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.15%
1/653 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.15%
1/653 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.15%
1/653 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.15%
1/653 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.15%
1/653 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/653 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.42%
1/240 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/653 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.41%
1/242 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Psychiatric disorders
Disorientation
|
0.15%
1/653 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Psychiatric disorders
Psychiatric symptom
|
0.15%
1/653 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/242 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Psychiatric disorders
Confusional state
|
0.31%
2/653 • Number of events 2 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.41%
1/242 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
Other adverse events
| Measure |
Atezolizumab + Carboplatin + Etoposide
n=653 participants at risk
Participants received atezolizumab, 1200 mg, Q3W as IV infusion on Day 1 of each 21-day cycle in combination with carboplatin on Day 1 and etoposide, in accordance with local standard of care, on Days 1, 2, and 3 of each cycle for up to 4 cycles.
|
Atezolizumab
n=240 participants at risk
Participants received atezolizumab, 1200 mg, Q3W as IV infusion on Day 1 of each 21-day cycle until unacceptable toxicity or PD whichever occurred first.
|
Atezolizumab+ Lurbinectedin
n=242 participants at risk
Participants received atezolizumab, 1200 mg, Q3W, as IV infusion and lurbinectedin, 3.2 mg/m\^2, Q3W, as IV infusion on Day 1 of each 21-day cycle until unacceptable toxicity or PD whichever occurred first.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Alopecia
|
16.5%
108/653 • Number of events 110 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.83%
2/240 • Number of events 2 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.41%
1/242 • Number of events 1 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.9%
32/653 • Number of events 34 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
7.1%
17/240 • Number of events 20 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
7.4%
18/242 • Number of events 20 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Endocrine disorders
Hypothyroidism
|
2.3%
15/653 • Number of events 15 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
7.1%
17/240 • Number of events 22 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
7.0%
17/242 • Number of events 18 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
General disorders
Asthenia
|
10.4%
68/653 • Number of events 81 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
6.2%
15/240 • Number of events 19 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
12.8%
31/242 • Number of events 47 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
General disorders
Fatigue
|
11.6%
76/653 • Number of events 88 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
7.9%
19/240 • Number of events 21 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
19.8%
48/242 • Number of events 59 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
7.4%
48/653 • Number of events 60 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
2.1%
5/240 • Number of events 5 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
5.0%
12/242 • Number of events 18 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
5.2%
34/653 • Number of events 42 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
4.6%
11/240 • Number of events 14 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
4.5%
11/242 • Number of events 19 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
10.3%
67/653 • Number of events 69 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
6.7%
16/240 • Number of events 18 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
16.9%
41/242 • Number of events 51 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.7%
44/653 • Number of events 46 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
6.2%
15/240 • Number of events 15 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
7.9%
19/242 • Number of events 21 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.4%
29/653 • Number of events 30 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
6.7%
16/240 • Number of events 16 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
9.5%
23/242 • Number of events 23 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
9.0%
59/653 • Number of events 84 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
1.7%
4/240 • Number of events 4 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
12.4%
30/242 • Number of events 53 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Blood and lymphatic system disorders
Anaemia
|
41.0%
268/653 • Number of events 319 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
6.7%
16/240 • Number of events 16 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
31.0%
75/242 • Number of events 116 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Blood and lymphatic system disorders
Neutropenia
|
16.8%
110/653 • Number of events 162 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
1.7%
4/240 • Number of events 6 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
10.7%
26/242 • Number of events 42 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Gastrointestinal disorders
Vomiting
|
5.4%
35/653 • Number of events 40 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
2.5%
6/240 • Number of events 6 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
13.6%
33/242 • Number of events 49 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Gastrointestinal disorders
Diarrhoea
|
8.4%
55/653 • Number of events 62 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
7.5%
18/240 • Number of events 21 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
14.0%
34/242 • Number of events 41 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Gastrointestinal disorders
Nausea
|
17.5%
114/653 • Number of events 138 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
3.8%
9/240 • Number of events 9 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
35.5%
86/242 • Number of events 151 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Gastrointestinal disorders
Constipation
|
13.8%
90/653 • Number of events 103 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
5.4%
13/240 • Number of events 13 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
11.2%
27/242 • Number of events 32 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Nervous system disorders
Dizziness
|
2.6%
17/653 • Number of events 21 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
2.1%
5/240 • Number of events 5 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
6.6%
16/242 • Number of events 20 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Nervous system disorders
Headache
|
2.1%
14/653 • Number of events 14 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
2.5%
6/240 • Number of events 6 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
6.2%
15/242 • Number of events 16 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.1%
20/653 • Number of events 21 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
5.0%
12/240 • Number of events 13 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
7.9%
19/242 • Number of events 21 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/653 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
0.00%
0/240 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
6.6%
16/242 • Number of events 18 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Investigations
Neutrophil count decreased
|
15.6%
102/653 • Number of events 151 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
1.2%
3/240 • Number of events 3 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
12.8%
31/242 • Number of events 49 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Investigations
Platelet count decreased
|
7.5%
49/653 • Number of events 63 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
2.9%
7/240 • Number of events 7 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
14.5%
35/242 • Number of events 57 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Investigations
Aspartate aminotransferase increased
|
2.6%
17/653 • Number of events 20 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
4.6%
11/240 • Number of events 12 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
6.2%
15/242 • Number of events 18 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Investigations
Blood creatinine increased
|
2.8%
18/653 • Number of events 21 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
1.2%
3/240 • Number of events 3 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
5.4%
13/242 • Number of events 15 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Investigations
White blood cell count decreased
|
4.7%
31/653 • Number of events 46 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
2.1%
5/240 • Number of events 8 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
7.4%
18/242 • Number of events 32 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
|
Investigations
Alanine aminotransferase increased
|
3.8%
25/653 • Number of events 28 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
3.8%
9/240 • Number of events 11 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
6.2%
15/242 • Number of events 19 • Enrollment Phase: Up to 6 months Randomization Phase: up to 26 months Study is ongoing & data up to primary clinical cut-off date is reported. Final data to be reported 1 year after study completion.
All-Cause Mortality was assessed on all participants enrolled in the study. AE \& SAE:Enrolled SAS=all enrolled participants who received at least 1 dose of treatment, regardless of whether/not, they were randomized. SAS=all participants who were randomized \& received at least 1 dose of atezolizumab/lurbinectedin.
|
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