Trial Outcomes & Findings for A Study of Atezolizumab in Participants With Programmed Death-Ligand 1 (PD-L1) Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) [FIR] (NCT NCT01846416)
NCT ID: NCT01846416
Last Updated: 2019-01-08
Results Overview
Objective response was defined as a complete response (CR) or partial response (PR), as determined by investigator according to modified RECIST criteria. Modified RECIST was derived from RECIST v1.1 conventions and immune related response criteria. CR was defined as disappearance of all tumor lesions (target lesion \[TL\] and non-target lesion \[non-TL\]) and no new measurable or unmeasurable lesions, all lymph node short axes must be less than 10 millimeters (mm), and PR was defined as at least 30 percent (%) decrease in sum of diameter of TLs and all new measurable lesions since baseline in absence of CR, and both confirmed by consecutive assessment greater than or equal to 4 weeks from date first documented. Participants not meeting these criteria, including participants without at least one post-baseline response assessment were considered as non-responders.
COMPLETED
PHASE2
138 participants
Baseline, and Day 1 of Cycle 1 (21-day cycle), then every 6 weeks for the first 12 months and then every 9 weeks thereafter until disease progression (up to 20 months)
2019-01-08
Participant Flow
Overall 201 participants were screened for clinical eligibility, out of which 63 participants were screen failures, and hence 138 participants were enrolled, and 137 participants received treatment.
Participant milestones
| Measure |
Atezolizumab (MPDL3280) : 1L Participants
Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
|
Atezolizumab (MPDL3280): 2L+ Participants
Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
|
Atezolizumab (MPDL3280): 2L+ Brain Metastases Participants
Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
|
|---|---|---|---|
|
Treatment Phase
STARTED
|
31
|
93
|
13
|
|
Treatment Phase
COMPLETED
|
0
|
0
|
0
|
|
Treatment Phase
NOT COMPLETED
|
31
|
93
|
13
|
|
Survival Follow-up
STARTED
|
28
|
80
|
12
|
|
Survival Follow-up
COMPLETED
|
0
|
0
|
0
|
|
Survival Follow-up
NOT COMPLETED
|
28
|
80
|
12
|
Reasons for withdrawal
| Measure |
Atezolizumab (MPDL3280) : 1L Participants
Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
|
Atezolizumab (MPDL3280): 2L+ Participants
Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
|
Atezolizumab (MPDL3280): 2L+ Brain Metastases Participants
Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
|
|---|---|---|---|
|
Treatment Phase
Death
|
2
|
9
|
1
|
|
Treatment Phase
Withdrawal by Subject
|
2
|
4
|
2
|
|
Treatment Phase
Other
|
1
|
5
|
1
|
|
Treatment Phase
Physician Decision
|
1
|
2
|
0
|
|
Treatment Phase
Adverse Event
|
3
|
4
|
0
|
|
Treatment Phase
Non-compliance
|
0
|
2
|
0
|
|
Treatment Phase
Study Terminated by Sponsor
|
1
|
4
|
0
|
|
Treatment Phase
Progressive Disease
|
21
|
63
|
9
|
|
Survival Follow-up
Death
|
21
|
62
|
9
|
|
Survival Follow-up
Lost to Follow-up
|
0
|
2
|
2
|
|
Survival Follow-up
Withdrawal by Subject
|
2
|
7
|
0
|
|
Survival Follow-up
Study Terminated by Sponsor
|
2
|
8
|
0
|
|
Survival Follow-up
Other
|
3
|
1
|
1
|
Baseline Characteristics
A Study of Atezolizumab in Participants With Programmed Death-Ligand 1 (PD-L1) Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) [FIR]
Baseline characteristics by cohort
| Measure |
Atezolizumab (MPDL3280) : 1L Participants
n=31 Participants
Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
|
Atezolizumab (MPDL3280) : 2L+ Participants
n=93 Participants
Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
|
Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants
n=13 Participants
Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
|
Total
n=137 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
68 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
65.2 years
STANDARD_DEVIATION 9.3 • n=7 Participants
|
63.8 years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
65.7 years
STANDARD_DEVIATION 9.6 • n=4 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
79 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, and Day 1 of Cycle 1 (21-day cycle), then every 6 weeks for the first 12 months and then every 9 weeks thereafter until disease progression (up to 20 months)Population: Efficacy-evaluable population; all treated participants who received at least 1 dose of atezolizumab during study.
Objective response was defined as a complete response (CR) or partial response (PR), as determined by investigator according to modified RECIST criteria. Modified RECIST was derived from RECIST v1.1 conventions and immune related response criteria. CR was defined as disappearance of all tumor lesions (target lesion \[TL\] and non-target lesion \[non-TL\]) and no new measurable or unmeasurable lesions, all lymph node short axes must be less than 10 millimeters (mm), and PR was defined as at least 30 percent (%) decrease in sum of diameter of TLs and all new measurable lesions since baseline in absence of CR, and both confirmed by consecutive assessment greater than or equal to 4 weeks from date first documented. Participants not meeting these criteria, including participants without at least one post-baseline response assessment were considered as non-responders.
Outcome measures
| Measure |
Atezolizumab (MPDL3280) : 1L Participants
n=31 Participants
Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
|
Atezolizumab (MPDL3280) : 2L+ Participants
n=93 Participants
Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
|
Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants
n=13 Participants
Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
|
|---|---|---|---|
|
Percentage of Participants With Objective Response According to Modified Response Evaluation Criteria in Solid Tumors (RECIST)
|
32 percentage of participants
Interval 17.0 to 51.0
|
21 percentage of participants
Interval 13.0 to 30.0
|
23 percentage of participants
Interval 5.0 to 54.0
|
SECONDARY outcome
Timeframe: Baseline, and Day 1 of Cycle 1 (21-day cycle), then every 6 weeks for the first 12 months and then every 9 weeks thereafter until disease progression (up to 20 months)Population: Efficacy-evaluable population.
Objective response was defined as a CR or PR, as determined by the investigator according to RECIST v1.1. For TLs, CR was defined as disappearance of all TLs. Any pathological lymph nodes, whether target or non-target, must had reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameter of TLs, taking as reference the baseline sum of diameters, in absence of CR. For non-TLs, CR was defined as disappearance of all non-TLs and if applicable, normalization of tumor marker level. Participants not meeting these criteria, including participants without at least 1 post-baseline response assessment were considered as non-responders.
Outcome measures
| Measure |
Atezolizumab (MPDL3280) : 1L Participants
n=31 Participants
Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
|
Atezolizumab (MPDL3280) : 2L+ Participants
n=93 Participants
Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
|
Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants
n=13 Participants
Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
|
|---|---|---|---|
|
Percentage of Participants With Objective Response According to RECIST Version 1.1 (v1.1)
|
29 percentage of participants
Interval 14.0 to 48.0
|
19 percentage of participants
Interval 11.0 to 28.0
|
23 percentage of participants
Interval 5.0 to 54.0
|
SECONDARY outcome
Timeframe: Baseline, and Day 1 of Cycle 1 (21-day cycle), then every 6 weeks for the first 12 months and then every 9 weeks thereafter until disease progression (up to 20 months)Population: Efficacy-evaluable population with a confirmed objective response.
Duration of objective response was defined as time from initial occurrence of documented CR or PR until documented disease progression (using RECIST v1.1 as determined by investigator) or death, whichever occurred first. For TLs, CR was defined as disappearance of all TLs. Any pathological lymph nodes, whether target or non-target, must had reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in sum of diameter of TLs, taking as reference baseline sum of diameters, in absence of CR. Progressive disease was at least a 20% increase in sum of diameters of TLs, taking as reference smallest sum on study (nadir). For non-TLs, CR was defined as disappearance of all non-TLs and if applicable, normalization of tumor marker level. Progressive disease was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. Participants were censored at the date of last tumor assessment.
Outcome measures
| Measure |
Atezolizumab (MPDL3280) : 1L Participants
n=9 Participants
Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
|
Atezolizumab (MPDL3280) : 2L+ Participants
n=17 Participants
Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
|
Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants
n=3 Participants
Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
|
|---|---|---|---|
|
Duration of Objective Response According to RECIST v1.1
|
9.2 months
Interval 2.3 to 30.4
|
17.0 months
Interval 2.8 to 44.2
|
NA months
Interval 2.8 to 9.9
Median DOR was not reached.
|
SECONDARY outcome
Timeframe: Month 6Population: Efficacy-evaluable population with a confirmed objective response.
Duration of objective response at 6 months was defined as time from initial occurrence of documented CR or PR until Month 6. For TLs, CR was defined as disappearance of all TLs. Any pathological lymph nodes, whether target or non-target, must have reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in sum of diameter of TLs, taking as reference baseline sum of diameters, in absence of CR. For non-TLs, CR was defined as disappearance of all non-TLs and if applicable, normalization of tumor marker level. Participants were censored at the date of last tumor assessment.
Outcome measures
| Measure |
Atezolizumab (MPDL3280) : 1L Participants
n=8 Participants
Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
|
Atezolizumab (MPDL3280) : 2L+ Participants
n=15 Participants
Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
|
Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants
n=3 Participants
Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
|
|---|---|---|---|
|
Percentage of Participants With 6-Month Duration of Objective Response
|
75.0 percentage of participants
|
91.7 percentage of participants
|
66.7 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to the first occurrence of progression or death, whichever occurs earlier (up to 20 months)Population: Efficacy-evaluable population.
For TLs, progressive disease was defined as at least a 20% increase in the sum of diameters of TLs, taking as reference the smallest sum on study (nadir). For non-TLs, progressive disease was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs.
Outcome measures
| Measure |
Atezolizumab (MPDL3280) : 1L Participants
n=31 Participants
Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
|
Atezolizumab (MPDL3280) : 2L+ Participants
n=93 Participants
Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
|
Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants
n=13 Participants
Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
|
|---|---|---|---|
|
Percentage of Participants With Disease Progression or Death According to RECIST v1.1
|
67.7 percentage of participants
|
74.2 percentage of participants
|
84.6 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to the first occurrence of progression or death, whichever occurs earlier (up to 20 months)Population: Efficacy-evaluable population.
PFS was defined as time from randomization to first occurrence of documented disease progression (based on RECIST v1.1 criteria) or death due to any cause within 30 days of the last treatment, whichever occurs earlier as determined by investigator. For TLs, progressive disease was defined as at least a 20% increase in the sum of diameter of TLs, taking as reference the smallest sum on study (nadir). For non-TLs, progressive disease was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. In event of no disease progression or documented death, PFS was censored at date of last evaluable tumor assessment. Participants with no post-baseline tumor assessments were censored at the time of first dose plus 1 day.
Outcome measures
| Measure |
Atezolizumab (MPDL3280) : 1L Participants
n=31 Participants
Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
|
Atezolizumab (MPDL3280) : 2L+ Participants
n=93 Participants
Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
|
Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants
n=13 Participants
Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
|
|---|---|---|---|
|
Progression-Free Survival (PFS) According to RECIST v1.1
|
4.5 months
Interval 0.9 to 37.9
|
2.7 months
Interval 0.0 to 45.5
|
2.5 months
Interval 1.0 to 11.3
|
SECONDARY outcome
Timeframe: Months 6, 12 and 30Population: Efficacy-evaluable population.
Percentage of participants who were progression free at Month 6 and 12 (based on RECIST v1.1) was reported. For TLs, progressive disease was defined as at least a 20% increase in the sum of diameter of TLs, taking as reference the smallest sum on study (nadir). For non-TLs, progressive disease was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs.
Outcome measures
| Measure |
Atezolizumab (MPDL3280) : 1L Participants
n=31 Participants
Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
|
Atezolizumab (MPDL3280) : 2L+ Participants
n=93 Participants
Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
|
Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants
n=13 Participants
Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
|
|---|---|---|---|
|
Percentage of Participants With PFS at Month 6, Month 12 and Month 30 According to RECIST v1.1
Month 6
|
33.50 percentage of participants
|
32.29 percentage of participants
|
15.38 percentage of participants
|
|
Percentage of Participants With PFS at Month 6, Month 12 and Month 30 According to RECIST v1.1
Month 12
|
20 percentage of participants
|
23 percentage of participants
|
NA percentage of participants
Not estimable
|
|
Percentage of Participants With PFS at Month 6, Month 12 and Month 30 According to RECIST v1.1
Month 30
|
13 percentage of participants
|
10 percentage of participants
|
NA percentage of participants
Not estimable
|
SECONDARY outcome
Timeframe: Baseline to the first occurrence of progression or death, whichever occurs earlier (up to 20 months)Population: Efficacy-evaluable population.
For TLs, progressive disease was defined as at least a 20% increase in the sum of diameters of TLs and new measurable lesions, taking as reference the smallest sum recorded since treatment started.
Outcome measures
| Measure |
Atezolizumab (MPDL3280) : 1L Participants
n=31 Participants
Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
|
Atezolizumab (MPDL3280) : 2L+ Participants
n=93 Participants
Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
|
Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants
n=13 Participants
Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
|
|---|---|---|---|
|
Percentage of Participants With Disease Progression or Death According to Modified RECIST
|
58.1 percentage of participants
|
66.7 percentage of participants
|
69.2 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to the first occurrence of progression or death, whichever occurs earlier (up to 20 months)Population: Efficacy-evaluable population.
PFS according to modified RECIST was defined as time from first dose of atezolizumab to first occurrence of documented disease progression or death due to any cause, as determined by investigator for participants who discontinued at first documented radiographic progression. For participants who continued beyond first documented progression and had follow-up tumor assessment or death, PFS was defined as time from first dose of atezolizumab to subsequent radiographic progression or death. For TLs, progressive disease was defined as at least a 20% increase in the sum of diameters of TLs and new measurable lesions, taking as reference the smallest sum recorded since treatment started. In event of no disease progression or documented death, PFS was censored at date of last evaluable tumor assessment.
Outcome measures
| Measure |
Atezolizumab (MPDL3280) : 1L Participants
n=31 Participants
Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
|
Atezolizumab (MPDL3280) : 2L+ Participants
n=93 Participants
Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
|
Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants
n=13 Participants
Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
|
|---|---|---|---|
|
PFS According to Modified RECIST
|
5.5 months
Interval 0.9 to 37.9
|
3.7 months
Interval 0.0 to 45.5
|
4.3 months
Interval 1.1 to 16.2
|
SECONDARY outcome
Timeframe: Months 6, 12 and 30Population: Efficacy-evaluable population.
Percentage of participants who were progression free at Months 6 and 12 (according to modified RECIST). For TLs, progressive disease was defined as at least a 20% increase in the sum of diameters of TLs and new measurable lesions, taking as reference the smallest sum recorded since treatment started.
Outcome measures
| Measure |
Atezolizumab (MPDL3280) : 1L Participants
n=31 Participants
Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
|
Atezolizumab (MPDL3280) : 2L+ Participants
n=93 Participants
Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
|
Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants
n=13 Participants
Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
|
|---|---|---|---|
|
Percentage of Participants With PFS at Month 6, Month 12 and Month 30 According to Modified RECIST
Month 6
|
43.12 percentage of participants
|
39.10 percentage of participants
|
44.87 percentage of participants
|
|
Percentage of Participants With PFS at Month 6, Month 12 and Month 30 According to Modified RECIST
Month 12
|
31 percentage of participants
|
29 percentage of participants
|
24 percentage of participants
|
|
Percentage of Participants With PFS at Month 6, Month 12 and Month 30 According to Modified RECIST
Month 30
|
12 percentage of participants
|
10 percentage of participants
|
NA percentage of participants
Not estimable
|
SECONDARY outcome
Timeframe: Baseline till death or up to 20 months, whichever occurred firstPopulation: Efficacy-evaluable population.
Participants were followed for survival throughout the study.
Outcome measures
| Measure |
Atezolizumab (MPDL3280) : 1L Participants
n=31 Participants
Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
|
Atezolizumab (MPDL3280) : 2L+ Participants
n=93 Participants
Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
|
Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants
n=13 Participants
Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
|
|---|---|---|---|
|
Percentage of Participants With Death
|
74.2 percentage of participants
|
76.3 percentage of participants
|
76.9 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline till death or up to 20 months, whichever occurred firstPopulation: Efficacy-evaluable population.
OS was defined as the time from first dose of the study drug to the time of death from any cause of the study. Participants who were still alive at the time of analysis were censored at the time of their last study assessment (for active participants) or at the last date known alive (for participants in follow-up). If no post-baseline data were available, OS was censored at the date of first treatment plus 1 day.
Outcome measures
| Measure |
Atezolizumab (MPDL3280) : 1L Participants
n=31 Participants
Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
|
Atezolizumab (MPDL3280) : 2L+ Participants
n=93 Participants
Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
|
Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants
n=13 Participants
Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
|
|---|---|---|---|
|
Overall Survival (OS)
|
14.4 months
Interval 12.8 to 22.1
|
9.3 months
Interval 5.8 to 17.6
|
6.8 months
Interval 3.2 to 19.5
|
SECONDARY outcome
Timeframe: Pre-dose (0 hour) and 30 minutes after infusion on Day 1 of Cycle 1Population: Pharmacokinetic- evaluable population: All treated participants with pharmacokinetic data at specified time points. Here, Number of participants analyzed = number of participants with available data for this outcome. Per planned analysis, pharmacokinetic data were not analyzed separately for each cohort.
Outcome measures
| Measure |
Atezolizumab (MPDL3280) : 1L Participants
n=135 Participants
Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
|
Atezolizumab (MPDL3280) : 2L+ Participants
Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
|
Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants
Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
|
|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) for Atezolizumab
|
405 micrograms per milliliter (mcg/mL)
Geometric Coefficient of Variation 31.7
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (0 hour) on Day 1 of Cycles 2, 3, 4, 8, and 16Population: Pharmacokinetic- evaluable population. Here, Number of participants analyzed = number of participants with available data for this outcome, and n= number of participants with available data at the specified time point. Per planned analysis, pharmacokinetic data were not analyzed separately for each cohort.
Outcome measures
| Measure |
Atezolizumab (MPDL3280) : 1L Participants
n=125 Participants
Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
|
Atezolizumab (MPDL3280) : 2L+ Participants
Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
|
Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants
Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
|
|---|---|---|---|
|
Minimum Plasma Concentration (Cmin) for Atezolizumab
Pre-dose Cycle 2 (Day 1) (n= 125)
|
68.8 mcg/mL
Geometric Coefficient of Variation 55.3
|
—
|
—
|
|
Minimum Plasma Concentration (Cmin) for Atezolizumab
Pre-dose Cycle 3 (Day 1) (n= 100)
|
90.6 mcg/mL
Geometric Coefficient of Variation 136.6
|
—
|
—
|
|
Minimum Plasma Concentration (Cmin) for Atezolizumab
Pre-dose Cycle 4 (Day 1) (n= 92)
|
123 mcg/mL
Geometric Coefficient of Variation 136.9
|
—
|
—
|
|
Minimum Plasma Concentration (Cmin) for Atezolizumab
Pre-dose Cycle 8 (Day 1) (n= 51)
|
206 mcg/mL
Geometric Coefficient of Variation 45.9
|
—
|
—
|
|
Minimum Plasma Concentration (Cmin) for Atezolizumab
Pre-dose Cycle 16 (Day 1) (n= 1)
|
135 mcg/mL
Geometric Coefficient of Variation NA
Geometric co-efficient of variation was not calculated as only 1 participant was analyzed at the specified time point.
|
—
|
—
|
Adverse Events
Atezolizumab (MPDL3280A) : 1L Participants
Atezolizumab (MPDL3280A) : 2L+ Participants
Atezolizumab (MPDL3280A) : 2L+ Brain Metastases Participants
Serious adverse events
| Measure |
Atezolizumab (MPDL3280A) : 1L Participants
n=31 participants at risk
Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
|
Atezolizumab (MPDL3280A) : 2L+ Participants
n=93 participants at risk
Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
|
Atezolizumab (MPDL3280A) : 2L+ Brain Metastases Participants
n=13 participants at risk
Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.2%
1/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
6.5%
6/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
9.7%
3/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
2.2%
2/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.2%
1/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
1.1%
1/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
2.2%
2/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
2.2%
2/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
1.1%
1/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchostenosis
|
3.2%
1/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
1.1%
1/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
1.1%
1/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
1.1%
1/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
1.1%
1/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Infections and infestations
Pneumonia
|
9.7%
3/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
8.6%
8/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
1.1%
1/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.5%
2/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Infections and infestations
Abscess neck
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
1.1%
1/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Infections and infestations
Bronchitis
|
3.2%
1/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Infections and infestations
Groin abscess
|
3.2%
1/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Infections and infestations
Herpes zoster disseminated
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
1.1%
1/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Infections and infestations
Influenza
|
3.2%
1/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Infections and infestations
Sepsis
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
1.1%
1/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
1.1%
1/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Cardiac disorders
Cardiac tamponade
|
3.2%
1/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Cardiac disorders
Pericardial effusion
|
3.2%
1/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
2.2%
2/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
1.1%
1/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Cardiac disorders
Cardiac arrest
|
3.2%
1/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
1.1%
1/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Cardiac disorders
Myocardial infarction
|
3.2%
1/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Cardiac disorders
Pericarditis constrictive
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
1.1%
1/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.5%
2/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
3.2%
3/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
3.2%
1/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
1.1%
1/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
1.1%
1/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
7.7%
1/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
1.1%
1/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
7.7%
1/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.5%
2/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
1.1%
1/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.2%
1/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Gastrointestinal disorders
Abdominal wall haematoma
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
1.1%
1/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Gastrointestinal disorders
Constipation
|
3.2%
1/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
1.1%
1/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Gastrointestinal disorders
Nausea
|
3.2%
1/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
1.1%
1/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Gastrointestinal disorders
Vomiting
|
3.2%
1/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
General disorders
Chest pain
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
2.2%
2/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
15.4%
2/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
General disorders
Pain
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
2.2%
2/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
General disorders
Pyrexia
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
7.7%
1/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Nervous system disorders
Guillain-Barre Syndrome
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
1.1%
1/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Nervous system disorders
Intracranial venous sinus thrombosis
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
1.1%
1/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Nervous system disorders
Monoparesis
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
1.1%
1/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Nervous system disorders
Nervous system disorder
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
1.1%
1/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Nervous system disorders
Seizure
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
1.1%
1/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Nervous system disorders
Syncope
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
1.1%
1/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Nervous system disorders
Vocal cord paralysis
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
1.1%
1/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Vascular disorders
Deep vein thrombosis
|
3.2%
1/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Vascular disorders
Embolism
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
1.1%
1/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Vascular disorders
Hypertension
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
1.1%
1/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Vascular disorders
Jugular vein thrombosis
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
1.1%
1/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
7.7%
1/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
3.2%
1/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
3.2%
1/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
1.1%
1/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
1.1%
1/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
1.1%
1/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
1.1%
1/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
7.7%
1/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
1.1%
1/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Endocrine disorders
Thyroiditis acute
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
1.1%
1/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Eye disorders
Amaurosis fugax
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
1.1%
1/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Eye disorders
Photopsia
|
3.2%
1/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Investigations
Alanine aminotransferase increased
|
3.2%
1/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
1.1%
1/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Investigations
Aspartate aminotransferase increased
|
3.2%
1/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
1.1%
1/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
1.1%
1/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
7.7%
1/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Renal and urinary disorders
Renal failure
|
3.2%
1/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
1.1%
1/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Cardiac disorders
PALPITATIONS
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
1.1%
1/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Gastrointestinal disorders
AUTOIMMUNE COLITIS
|
3.2%
1/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Gastrointestinal disorders
COLITIS
|
3.2%
1/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Hepatobiliary disorders
HEPATIC FUNCTION ABNORMAL
|
3.2%
1/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Investigations
INFLUENZA B VIRUS TEST POSITIVE
|
3.2%
1/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
1.1%
1/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
1.1%
1/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
3.2%
1/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
Other adverse events
| Measure |
Atezolizumab (MPDL3280A) : 1L Participants
n=31 participants at risk
Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
|
Atezolizumab (MPDL3280A) : 2L+ Participants
n=93 participants at risk
Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
|
Atezolizumab (MPDL3280A) : 2L+ Brain Metastases Participants
n=13 participants at risk
Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
|
|---|---|---|---|
|
General disorders
Fatigue
|
51.6%
16/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
40.9%
38/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
38.5%
5/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
General disorders
Pyrexia
|
22.6%
7/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
22.6%
21/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
7.7%
1/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
General disorders
Oedema peripheral
|
9.7%
3/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
15.1%
14/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
15.4%
2/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
General disorders
Chest pain
|
3.2%
1/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
9.7%
9/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
General disorders
Pain
|
9.7%
3/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
2.2%
2/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
15.4%
2/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
General disorders
Asthenia
|
3.2%
1/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
9.7%
9/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
General disorders
Chills
|
3.2%
1/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
5.4%
5/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
7.7%
1/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
General disorders
Influenza like illness
|
9.7%
3/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
4.3%
4/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
7.7%
1/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
General disorders
Malaise
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
6.5%
6/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
General disorders
Gait disturbance
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
7.7%
1/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
General disorders
General physical health deterioration
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
7.7%
1/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Gastrointestinal disorders
Nausea
|
35.5%
11/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
29.0%
27/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
30.8%
4/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Gastrointestinal disorders
Constipation
|
25.8%
8/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
17.2%
16/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
46.2%
6/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Gastrointestinal disorders
Diarrhoea
|
25.8%
8/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
18.3%
17/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
30.8%
4/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Gastrointestinal disorders
Vomiting
|
12.9%
4/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
15.1%
14/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
23.1%
3/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Gastrointestinal disorders
Dysphagia
|
6.5%
2/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
8.6%
8/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
7.7%
1/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
6.5%
2/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
7.5%
7/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.2%
1/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
7.5%
7/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
3.2%
3/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
7.7%
1/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.5%
2/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
5.4%
5/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
7.7%
1/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Gastrointestinal disorders
Mouth swelling
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
7.7%
1/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.1%
5/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
35.5%
33/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
23.1%
3/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
25.8%
8/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
32.3%
30/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
23.1%
3/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
6.5%
2/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
14.0%
13/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
9.7%
3/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
7.5%
7/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
15.4%
2/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
3.2%
1/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
6.5%
6/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
7.7%
1/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
9.7%
3/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
6.5%
6/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
7.7%
1/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
3.2%
1/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
6.5%
6/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.5%
2/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
5.4%
5/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
15.4%
2/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
3.2%
1/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
5.4%
5/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
1.1%
1/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
7.7%
1/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
19.4%
6/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
19.4%
18/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
15.4%
2/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.9%
4/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
20.4%
19/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
15.4%
2/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.5%
2/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
8.6%
8/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
7.7%
1/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
12.9%
4/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
9.7%
9/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
7.7%
1/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
3.2%
1/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
8.6%
8/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.7%
3/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
5.4%
5/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
7.7%
1/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
3.2%
1/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
5.4%
5/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
3.2%
3/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
7.7%
1/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
4.3%
4/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
7.7%
1/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
19.4%
6/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
23.7%
22/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
15.4%
2/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.5%
2/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
12.9%
12/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
30.8%
4/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
9.7%
3/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
12.9%
12/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Metabolism and nutrition disorders
Dehydration
|
6.5%
2/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
7.5%
7/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
7.7%
1/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
8.6%
8/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
6.5%
2/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
6.5%
6/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
3.2%
1/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
6.5%
6/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.1%
5/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
9.7%
9/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
7.7%
1/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.2%
1/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
12.9%
12/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
6.5%
2/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
7.5%
7/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
7.7%
1/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.7%
3/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
9.7%
9/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
7.7%
1/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
6.5%
2/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
7.7%
1/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
1.1%
1/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
7.7%
1/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.5%
2/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
18.3%
17/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Infections and infestations
Pneumonia
|
3.2%
1/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
8.6%
8/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Infections and infestations
Urinary tract infection
|
22.6%
7/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
3.2%
3/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
15.4%
2/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Infections and infestations
Candida infection
|
6.5%
2/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
1.1%
1/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Infections and infestations
Cystitis
|
6.5%
2/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Infections and infestations
Fungal skin infection
|
3.2%
1/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
1.1%
1/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
7.7%
1/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Infections and infestations
Influenza
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
7.7%
1/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
1.1%
1/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
7.7%
1/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Psychiatric disorders
Insomnia
|
12.9%
4/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
11.8%
11/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
7.7%
1/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
11.8%
11/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
15.4%
2/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Psychiatric disorders
Depression
|
9.7%
3/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
9.7%
9/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
7.7%
1/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Psychiatric disorders
Confusional state
|
3.2%
1/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
4.3%
4/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
7.7%
1/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
2.2%
2/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
7.7%
1/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Blood and lymphatic system disorders
Anaemia
|
19.4%
6/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
20.4%
19/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
7.7%
1/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Blood and lymphatic system disorders
Neutropenia
|
6.5%
2/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
2.2%
2/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.2%
1/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
7.7%
1/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
7.7%
1/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Nervous system disorders
Headache
|
16.1%
5/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
10.8%
10/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
23.1%
3/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Nervous system disorders
Dizziness
|
12.9%
4/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
8.6%
8/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
7.7%
1/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Nervous system disorders
Dysgeusia
|
12.9%
4/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
4.3%
4/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
1.1%
1/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
7.7%
1/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
7.7%
1/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
1.1%
1/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
7.7%
1/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
1.1%
1/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
7.7%
1/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Nervous system disorders
Nystagmus
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
7.7%
1/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Nervous system disorders
Syncope
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
7.7%
1/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Investigations
Weight decreased
|
19.4%
6/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
9.7%
9/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
7.7%
1/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Investigations
Alanine aminotransferase increased
|
6.5%
2/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
2.2%
2/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
15.4%
2/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Investigations
Aspartate aminotransferase increased
|
6.5%
2/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
3.2%
3/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
15.4%
2/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Investigations
LYMPHOCYTE COUNT DECREASED
|
6.5%
2/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
3.2%
3/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
1.1%
1/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
7.7%
1/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Investigations
Haemoglobin decreased
|
3.2%
1/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
7.7%
1/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
7.7%
1/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Vascular disorders
Hypotension
|
9.7%
3/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
9.7%
9/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Vascular disorders
Hypertension
|
9.7%
3/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
3.2%
3/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
7.7%
1/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Vascular disorders
Hot flush
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
2.2%
2/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
7.7%
1/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Vascular disorders
Haematoma
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
7.7%
1/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
3.2%
3/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
7.7%
1/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Cardiac disorders
Atrial fibrillation
|
6.5%
2/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
2.2%
2/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
2.2%
2/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
7.7%
1/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Cardiac disorders
Aortic valve thickening
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
7.7%
1/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Eye disorders
Diplopia
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
2.2%
2/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
7.7%
1/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
2.2%
2/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
7.7%
1/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Eye disorders
Vision blurred
|
6.5%
2/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
1.1%
1/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
7.7%
1/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
7.7%
1/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
4.3%
4/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
15.4%
2/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Ear and labyrinth disorders
Vertigo
|
3.2%
1/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
1.1%
1/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
7.7%
1/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Ear and labyrinth disorders
EXCESSIVE CERUMEN PRODUCTION
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
7.7%
1/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Ear and labyrinth disorders
Deafness bilateral
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
7.7%
1/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
7.7%
1/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
7.7%
1/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Endocrine disorders
Hypothyroidism
|
3.2%
1/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
3.2%
3/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
7.7%
1/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Injury, poisoning and procedural complications
FALL
|
3.2%
1/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
6.5%
6/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Injury, poisoning and procedural complications
JAW FRACTURE
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
7.7%
1/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Injury, poisoning and procedural complications
LACERATION
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
7.7%
1/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Reproductive system and breast disorders
Breast swelling
|
3.2%
1/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
7.7%
1/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
7.7%
1/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Eye disorders
CONJUNCTIVAL HYPERAEMIA
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
1.1%
1/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
7.7%
1/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN LOWER
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
3.2%
3/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
7.7%
1/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Gastrointestinal disorders
STOMATITIS
|
6.5%
2/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
3.2%
3/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Infections and infestations
SINUSITIS
|
6.5%
2/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
2.2%
2/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Injury, poisoning and procedural complications
LIMB INJURY
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
7.7%
1/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Musculoskeletal and connective tissue disorders
FLANK PAIN
|
0.00%
0/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
5.4%
5/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
6.5%
2/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
4.3%
4/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Nervous system disorders
PARAESTHESIA
|
6.5%
2/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
4.3%
4/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
6.5%
2/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
6.5%
2/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
5.4%
5/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
6.5%
2/31 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
3.2%
3/93 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
0.00%
0/13 • Baseline until 20 months.
All participants who received at least one dose of atezolizumab were included in analysis.
|
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