Trial Outcomes & Findings for A Study of Atezolizumab as Neoadjuvant and Adjuvant Therapy in Resectable Non-Small Cell Lung Cancer (NSCLC) - Lung Cancer Mutation Consortium (LCMC3) (NCT NCT02927301)
NCT ID: NCT02927301
Last Updated: 2024-09-19
Results Overview
Major pathologic response was defined as ≤10% of viable tumor cells as scored by a pathologist, based on surgical resection as defined by prior studies. Percentages have been rounded off to the nearest decimal point.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
181 participants
Primary outcome timeframe
After surgery (approximately 10 weeks)
Results posted on
2024-09-19
Participant Flow
A total of 181 participants diagnosed with Stage IB, II, IIIA, or selected IIIB resectable and untreated non-small-cell lung cancer (NSCLC) took part in the study in the United States from 20 Apr 2017 to 05 Sep 2023.
Participant milestones
| Measure |
Atezolizumab
Participants received atezolizumab, 1200 milligram (mg) as intravenous (IV) infusion, once every 21 days (Q21D) for a maximum of 2 cycles (1 cycle=21 days) as neo-adjuvant therapy. Participants who demonstrated clinical benefit from neo-adjuvant therapy and subsequently underwent surgery then received adjuvant treatment with atezolizumab, 1200 mg, as IV infusion, Q21D for a maximum of 12 months.
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|---|---|
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Overall Study
STARTED
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181
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Overall Study
Participants Who Had Surgery
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159
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Overall Study
COMPLETED
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115
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Overall Study
NOT COMPLETED
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66
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Reasons for withdrawal
| Measure |
Atezolizumab
Participants received atezolizumab, 1200 milligram (mg) as intravenous (IV) infusion, once every 21 days (Q21D) for a maximum of 2 cycles (1 cycle=21 days) as neo-adjuvant therapy. Participants who demonstrated clinical benefit from neo-adjuvant therapy and subsequently underwent surgery then received adjuvant treatment with atezolizumab, 1200 mg, as IV infusion, Q21D for a maximum of 12 months.
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|---|---|
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Overall Study
Death
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39
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Overall Study
Lost to Follow-up
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8
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Overall Study
Physician Decision
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2
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Overall Study
Withdrawal by Subject
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12
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Overall Study
Study Ended By Sponsor While in Survival Follow-Up
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5
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Baseline Characteristics
A Study of Atezolizumab as Neoadjuvant and Adjuvant Therapy in Resectable Non-Small Cell Lung Cancer (NSCLC) - Lung Cancer Mutation Consortium (LCMC3)
Baseline characteristics by cohort
| Measure |
Atezolizumab
n=181 Participants
Participants received atezolizumab, 1200 mg as IV infusion, Q21D for a maximum of 2 cycles (1 cycle=21 days) as neo-adjuvant therapy. Participants who demonstrated clinical benefit from neo-adjuvant therapy and subsequently underwent surgery then received adjuvant treatment with atezolizumab, 1200 mg, as IV infusion, Q21D for a maximum of 12 months.
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|---|---|
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Age, Continuous
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65.1 Years
STANDARD_DEVIATION 9.23 • n=5 Participants
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Sex: Female, Male
Female
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93 Participants
n=5 Participants
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Sex: Female, Male
Male
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88 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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8 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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159 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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14 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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9 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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13 Participants
n=5 Participants
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Race (NIH/OMB)
White
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145 Participants
n=5 Participants
|
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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14 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: After surgery (approximately 10 weeks)Population: The Primary Efficacy Population (PEP) included NSCLC participants who had received surgery after neoadjuvant treatment with atezolizumab, received at least one dose of the study drug, and who did not have Epidermal Growth Factor Receptor (EGFR) or Anaplastic Lymphoma Kinase (ALK) mutant tumors. The overall number analyzed was the number of participants with data available for analysis.
Major pathologic response was defined as ≤10% of viable tumor cells as scored by a pathologist, based on surgical resection as defined by prior studies. Percentages have been rounded off to the nearest decimal point.
Outcome measures
| Measure |
Atezolizumab
n=143 Participants
Participants received atezolizumab, 1200 mg as IV infusion, Q21D for a maximum of 2 cycles (1 cycle=21 days) as neo-adjuvant therapy. Participants who demonstrated clinical benefit from neo-adjuvant therapy and subsequently underwent surgery then received adjuvant treatment with atezolizumab, 1200 mg, as IV infusion, Q21D for a maximum of 12 months.
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|---|---|
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Percentage of Participants With Major Pathologic Response (MPR)
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20.3 percentage of participants
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SECONDARY outcome
Timeframe: Pre-surgery (Day 36 +/- 3 days), after 2 doses of neoadjuvant treatment with atezolizumabPopulation: The overall number analyzed included participants in the PEP with non-missing ORR data and PD-L1 status. The PEP included participants with NSCLC who had received surgery after neoadjuvant treatment with atezolizumab, received at least one dose of the study drug, and who did not have EGFR or ALK mutant tumors. The number analyzed per row was the number of participants with data available for analysis in each PD-L1 group.
ORR was defined as percentage of participants with complete response (CR) or partial response (PR) as determined by the investigator using RECIST v.1.1, assessed in the programmed death ligand 1 (PD-L1) positive (participants with combined tumor cell (TC)/ immune cell (IC) score categorized as TC1/2/3 or IC1/2/3) and PD-L1 negative (participants with TC/IC score was categorized as TC0 and IC0) groups. CR was defined as the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in short axis to \<10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. Percentages have been rounded off to the nearest decimal point.
Outcome measures
| Measure |
Atezolizumab
n=112 Participants
Participants received atezolizumab, 1200 mg as IV infusion, Q21D for a maximum of 2 cycles (1 cycle=21 days) as neo-adjuvant therapy. Participants who demonstrated clinical benefit from neo-adjuvant therapy and subsequently underwent surgery then received adjuvant treatment with atezolizumab, 1200 mg, as IV infusion, Q21D for a maximum of 12 months.
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|---|---|
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Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) for PD-L1-Positive Versus PD-L1-Negative Participants
PD-L1 Positive Group
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13.3 percentage of participants
Interval 5.9 to 24.6
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Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) for PD-L1-Positive Versus PD-L1-Negative Participants
PD-L1 Negative Group
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1.9 percentage of participants
Interval 0.1 to 10.3
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SECONDARY outcome
Timeframe: After surgery (approximately 10 weeks)Population: The overall number analyzed included participants in the PEP with non-missing MPR data and PD-L1 status. PEP included participants with NSCLC who had received surgery after neoadjuvant treatment with atezolizumab, received at least one dose of the study drug, and who did not have EGFR or ALK mutant tumors. The number analyzed per row was the number of participants with data available for analysis in each PD-L1 group.
Major pathologic response (MPR) was defined as ≤10% of viable tumor cells, as scored by a pathologist, based on surgical resection as defined by prior studies. MPR was assessed based on participants tumor cell (TC) and immune cell (IC) score. The participants were considered as PD-L1- positive if their combined TC/IC score was categorized as TC1/2/3 or IC1/2/3 and the participants were considered PD-L1 negative if TC/IC score was categorized as TC0 and IC0. Percentages have been rounded off to the nearest decimal point.
Outcome measures
| Measure |
Atezolizumab
n=109 Participants
Participants received atezolizumab, 1200 mg as IV infusion, Q21D for a maximum of 2 cycles (1 cycle=21 days) as neo-adjuvant therapy. Participants who demonstrated clinical benefit from neo-adjuvant therapy and subsequently underwent surgery then received adjuvant treatment with atezolizumab, 1200 mg, as IV infusion, Q21D for a maximum of 12 months.
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|---|---|
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Percentage of Participants With Major Pathologic Response for PD-L1-Positive Versus PD-L1-Negative Participants
PD-L1 Positive Group
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29.8 percentage of participants
Interval 18.4 to 43.4
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Percentage of Participants With Major Pathologic Response for PD-L1-Positive Versus PD-L1-Negative Participants
PD-L1 Negative Group
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13.5 percentage of participants
Interval 5.6 to 25.8
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SECONDARY outcome
Timeframe: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months)Population: Safety population included all enrolled NSCLC participants who have received any dose of study drug.
An adverse event (AE) was defined as any untoward medical occurrence in participant administered a pharmaceutical product \& regardless of causal relationship with this treatment. An AE can therefore be any unfavorable \& unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with use of investigational product, whether or not considered related to investigational product. AEs were reported based on the National Cancer Institute Common Terminology Criteria for AEs, version 4.0 (NCI-CTCAE, v4.0).
Outcome measures
| Measure |
Atezolizumab
n=181 Participants
Participants received atezolizumab, 1200 mg as IV infusion, Q21D for a maximum of 2 cycles (1 cycle=21 days) as neo-adjuvant therapy. Participants who demonstrated clinical benefit from neo-adjuvant therapy and subsequently underwent surgery then received adjuvant treatment with atezolizumab, 1200 mg, as IV infusion, Q21D for a maximum of 12 months.
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|---|---|
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Number of Participants With at Least One Adverse Event
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177 Participants
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SECONDARY outcome
Timeframe: Up to 13 weeksPopulation: The overall number analyzed included participants in the PEP with non-missing MPR and TMB data. The PEP included participants with NSCLC who had received surgery after neoadjuvant treatment with atezolizumab, received at least one dose of the study drug, and who did not have EGFR or ALK mutant tumors. The number analyzed per row is the number of participants with data available for analysis in each TMB subgroup.
MPR was defined as ≤10% of viable tumor cells in the surgical resection as scored by a pathologist. Whole-exome sequencing (WES) was run, and the consequences of each mutation were determined using Ensembl Variant Effect Predictor (VEP). Mutation load (i.e. tumor mutation burden (TMB)) was defined as the number of variants altering protein sequence as outlined by VEP divided by 34 Megabase (MB) of assay target region. The final value was reported as number of mutations per megabase (mut/MB). It was divided into three groups: TMB \<10 mut/MB; TMB ≥ 10 mut/MB to \<16 mut/MB; and TMB ≥16 mut/MB. Percentages have been rounded off to the nearest decimal point.
Outcome measures
| Measure |
Atezolizumab
n=86 Participants
Participants received atezolizumab, 1200 mg as IV infusion, Q21D for a maximum of 2 cycles (1 cycle=21 days) as neo-adjuvant therapy. Participants who demonstrated clinical benefit from neo-adjuvant therapy and subsequently underwent surgery then received adjuvant treatment with atezolizumab, 1200 mg, as IV infusion, Q21D for a maximum of 12 months.
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|---|---|
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Percentage of Participants With Major Pathologic Response (MPR) by Mutation Load
TMB <10 mut/MB
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16.7 percentage of participants
Interval 8.3 to 28.5
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Percentage of Participants With Major Pathologic Response (MPR) by Mutation Load
TMB ≥10 mut/MB to <16 mut/MB
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9.1 percentage of participants
Interval 0.2 to 41.3
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Percentage of Participants With Major Pathologic Response (MPR) by Mutation Load
TMB ≥16 mut/MB
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33.3 percentage of participants
Interval 11.8 to 61.6
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SECONDARY outcome
Timeframe: Up to 13 weeksPopulation: The overall number analyzed included participants in the PEP with non-missing MPR and neoantigen score data. The PEP included those with NSCLC who had received surgery after neoadjuvant treatment with atezolizumab, received at least one dose of the study drug, and who did not have EGFR or ALK mutant tumors. The number analyzed per row is the number of participants with data available for analysis in each neoantigen score subgroup.
MPR was defined as ≤10% of viable tumor cells in the surgical resection as scored by a pathologist. MPR was analysed by neoantigen score, which was assessed based on the number of highly immunogenic, expressed neoantigens detected at baseline. Median splits were applied for analyses of MPR. Neoantigen scores \>/= 73 (i.e. \>/= 73 highly immunogenic, expressed neoantigens detected at baseline) were considered as high scores, and scores \<73 (i.e. \<73 highly immunogenic, expressed neoantigens detected at baseline) were considered as low neoantigen scores. Percentages have been rounded off to the nearest decimal point.
Outcome measures
| Measure |
Atezolizumab
n=62 Participants
Participants received atezolizumab, 1200 mg as IV infusion, Q21D for a maximum of 2 cycles (1 cycle=21 days) as neo-adjuvant therapy. Participants who demonstrated clinical benefit from neo-adjuvant therapy and subsequently underwent surgery then received adjuvant treatment with atezolizumab, 1200 mg, as IV infusion, Q21D for a maximum of 12 months.
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|---|---|
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Percentage of Participants With Major Pathologic Response (MPR) by Neoantigen Score
Low score
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19.4 percentage of participants
Interval 7.5 to 37.5
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Percentage of Participants With Major Pathologic Response (MPR) by Neoantigen Score
High score
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25.8 percentage of participants
Interval 11.9 to 44.6
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SECONDARY outcome
Timeframe: Up to 13 weeksPopulation: The overall number analysed included participants in the PEP with non-missing MPR and GSVA score data. The PEP included participants with NSCLC who had received surgery after neoadjuvant treatment with atezolizumab, received at least one dose of the study drug, and who did not have EGFR or ALK mutant tumors. The number analyzed per row was the number of participants with data available for analysis in each GSVA score subgroup.
MPR was defined as ≤10% of viable tumor cells in the surgical resection as scored by a pathologist. MPR was analysed by gene set variation analysis (GSVA) scores. Bulk ribonucleic acid (RNA) from baseline tumor samples were assessed using GSVA for a T effector cell (Teff) signature comprising the following genes: cluster of differentiation 8A (CD8A), eomesodermin (EOMES), granzyme A (GZMA), T-box transcription factor 21 (TBX21), interferon-gamma (IFNG), granzyme B (GZMB), C-X-C motif chemokine ligand 9 (CXCL9), and C-X-C motif chemokine ligand 10 (CXCL10). Tertile splits were applied to GSVA scores, categorized as lower, middle, and upper scores, which indicated the relative levels of gene set expression in the baseline tumor samples. Percentages have been rounded off to the nearest decimal point.
Outcome measures
| Measure |
Atezolizumab
n=52 Participants
Participants received atezolizumab, 1200 mg as IV infusion, Q21D for a maximum of 2 cycles (1 cycle=21 days) as neo-adjuvant therapy. Participants who demonstrated clinical benefit from neo-adjuvant therapy and subsequently underwent surgery then received adjuvant treatment with atezolizumab, 1200 mg, as IV infusion, Q21D for a maximum of 12 months.
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|---|---|
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Percentage of Participants With Major Pathologic Response (MPR) by Gene Expression Signatures: Gene Set Variation Analysis (GSVA)
Lower score
|
17.6 percentage of participants
Interval 3.8 to 43.4
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Percentage of Participants With Major Pathologic Response (MPR) by Gene Expression Signatures: Gene Set Variation Analysis (GSVA)
Middle score
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35.3 percentage of participants
Interval 14.2 to 61.7
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Percentage of Participants With Major Pathologic Response (MPR) by Gene Expression Signatures: Gene Set Variation Analysis (GSVA)
Upper score
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33.3 percentage of participants
Interval 13.3 to 59.0
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SECONDARY outcome
Timeframe: Up to 13 weeksPopulation: The overall number analyzed included participants in the PEP with non-missing MPR and xCell immune score data. The PEP included participants with NSCLC who had received surgery after neoadjuvant treatment with atezolizumab, received at least one dose of the study drug, and who did not have EGFR or ALK mutant tumors. The number analyzed per row was the number of participants with data available for analysis in each xCell immune score subgroup.
MPR was defined as ≤10% of viable tumor cells in the surgical resection as scored by a pathologist. MPR was analysed by gene expression signatures. Bulk RNA from baseline tumor samples were assessed using xCell immune score. Tertile splits were applied to xCell immune scores, categorized as lower, middle, and upper scores, which indicated the relative levels of immune cell gene expression in the baseline tumor samples. Percentages have been rounded off to the nearest decimal point.
Outcome measures
| Measure |
Atezolizumab
n=52 Participants
Participants received atezolizumab, 1200 mg as IV infusion, Q21D for a maximum of 2 cycles (1 cycle=21 days) as neo-adjuvant therapy. Participants who demonstrated clinical benefit from neo-adjuvant therapy and subsequently underwent surgery then received adjuvant treatment with atezolizumab, 1200 mg, as IV infusion, Q21D for a maximum of 12 months.
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|---|---|
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Percentage of Participants With Major Pathologic Response (MPR) by Gene Expression Signatures: xCell Immune Score
Lower score
|
29.4 percentage of participants
Interval 10.3 to 56.0
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Percentage of Participants With Major Pathologic Response (MPR) by Gene Expression Signatures: xCell Immune Score
Middle score
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23.5 percentage of participants
Interval 6.8 to 49.9
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Percentage of Participants With Major Pathologic Response (MPR) by Gene Expression Signatures: xCell Immune Score
Upper score
|
33.3 percentage of participants
Interval 13.3 to 59.0
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Adverse Events
Atezolizumab
Serious events: 63 serious events
Other events: 168 other events
Deaths: 39 deaths
Serious adverse events
| Measure |
Atezolizumab
n=181 participants at risk
Participants received atezolizumab, 1200 mg as IV infusion, Q21D for a maximum of 2 cycles (1 cycle=21 days) as neo-adjuvant therapy. Participants who demonstrated clinical benefit from neo-adjuvant therapy and subsequently underwent surgery then received adjuvant treatment with atezolizumab, 1200 mg, as IV infusion, Q21D for a maximum of 12 months.
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|---|---|
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Blood and lymphatic system disorders
Anaemia
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0.55%
1/181 • Number of events 1 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
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Cardiac disorders
Acute myocardial infarction
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0.55%
1/181 • Number of events 1 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
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Cardiac disorders
Atrial fibrillation
|
1.7%
3/181 • Number of events 4 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
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Cardiac disorders
Cardiac arrest
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0.55%
1/181 • Number of events 1 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
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|
Cardiac disorders
Cardiac failure acute
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0.55%
1/181 • Number of events 2 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
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|
Gastrointestinal disorders
Diarrhoea
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0.55%
1/181 • Number of events 1 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
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|
Gastrointestinal disorders
Gastrointestinal haemorrhage
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0.55%
1/181 • Number of events 1 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Gastrointestinal disorders
Ileus
|
0.55%
1/181 • Number of events 1 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
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Gastrointestinal disorders
Nausea
|
0.55%
1/181 • Number of events 1 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.55%
1/181 • Number of events 1 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
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|
Infections and infestations
Diverticulitis
|
0.55%
1/181 • Number of events 1 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Infections and infestations
Empyema
|
1.1%
2/181 • Number of events 2 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Infections and infestations
Influenza
|
0.55%
1/181 • Number of events 1 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Infections and infestations
Pneumonia
|
5.0%
9/181 • Number of events 10 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Infections and infestations
Sepsis
|
1.1%
2/181 • Number of events 2 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Infections and infestations
Tooth infection
|
0.55%
1/181 • Number of events 1 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.55%
1/181 • Number of events 1 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.55%
1/181 • Number of events 1 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.55%
1/181 • Number of events 1 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Investigations
Blood potassium increased
|
0.55%
1/181 • Number of events 1 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.55%
1/181 • Number of events 1 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.55%
1/181 • Number of events 1 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.55%
1/181 • Number of events 1 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.55%
1/181 • Number of events 1 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.55%
1/181 • Number of events 1 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm malignant stage unspecified
|
0.55%
1/181 • Number of events 1 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.55%
1/181 • Number of events 1 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.55%
1/181 • Number of events 1 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Nervous system disorders
Ischaemic stroke
|
0.55%
1/181 • Number of events 1 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Nervous system disorders
Seizure
|
0.55%
1/181 • Number of events 1 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Nervous system disorders
Syncope
|
0.55%
1/181 • Number of events 1 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
0.55%
1/181 • Number of events 1 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Psychiatric disorders
Delirium
|
0.55%
1/181 • Number of events 1 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.55%
1/181 • Number of events 1 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Renal and urinary disorders
Azotaemia
|
0.55%
1/181 • Number of events 1 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Renal and urinary disorders
Urinary retention
|
0.55%
1/181 • Number of events 1 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.55%
1/181 • Number of events 1 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopleural fistula
|
0.55%
1/181 • Number of events 1 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.8%
5/181 • Number of events 5 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.1%
2/181 • Number of events 2 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.55%
1/181 • Number of events 1 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.1%
2/181 • Number of events 2 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.55%
1/181 • Number of events 1 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.3%
6/181 • Number of events 7 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.7%
3/181 • Number of events 3 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary air leakage
|
1.7%
3/181 • Number of events 3 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.55%
1/181 • Number of events 1 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.55%
1/181 • Number of events 1 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.55%
1/181 • Number of events 1 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.1%
2/181 • Number of events 2 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Subcutaneous emphysema
|
0.55%
1/181 • Number of events 1 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Vascular disorders
Hypotension
|
0.55%
1/181 • Number of events 1 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord dysfunction
|
0.55%
1/181 • Number of events 1 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Gastrointestinal disorders
Colitis
|
0.55%
1/181 • Number of events 1 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
General disorders
Influenza like illness
|
0.55%
1/181 • Number of events 1 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
General disorders
Non-cardiac chest pain
|
0.55%
1/181 • Number of events 1 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
General disorders
Pyrexia
|
2.8%
5/181 • Number of events 5 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
General disorders
Sudden death
|
0.55%
1/181 • Number of events 1 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.55%
1/181 • Number of events 1 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
0.55%
1/181 • Number of events 1 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Product Issues
Device leakage
|
0.55%
1/181 • Number of events 1 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
Other adverse events
| Measure |
Atezolizumab
n=181 participants at risk
Participants received atezolizumab, 1200 mg as IV infusion, Q21D for a maximum of 2 cycles (1 cycle=21 days) as neo-adjuvant therapy. Participants who demonstrated clinical benefit from neo-adjuvant therapy and subsequently underwent surgery then received adjuvant treatment with atezolizumab, 1200 mg, as IV infusion, Q21D for a maximum of 12 months.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
10.5%
19/181 • Number of events 19 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
21.5%
39/181 • Number of events 43 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
17.7%
32/181 • Number of events 39 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
22.1%
40/181 • Number of events 49 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
9.9%
18/181 • Number of events 21 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.1%
11/181 • Number of events 12 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
6.6%
12/181 • Number of events 14 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
8.8%
16/181 • Number of events 17 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
29.8%
54/181 • Number of events 55 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
7.7%
14/181 • Number of events 15 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
8.3%
15/181 • Number of events 16 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Investigations
Weight decreased
|
6.6%
12/181 • Number of events 14 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
21.0%
38/181 • Number of events 41 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
7.2%
13/181 • Number of events 14 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
5.5%
10/181 • Number of events 11 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
9.9%
18/181 • Number of events 20 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
18.2%
33/181 • Number of events 45 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.2%
22/181 • Number of events 23 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
5.5%
10/181 • Number of events 10 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Nervous system disorders
Dizziness
|
11.6%
21/181 • Number of events 22 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Nervous system disorders
Dysgeusia
|
5.5%
10/181 • Number of events 11 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Nervous system disorders
Headache
|
16.0%
29/181 • Number of events 33 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
6.6%
12/181 • Number of events 13 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
8.3%
15/181 • Number of events 15 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
11.0%
20/181 • Number of events 20 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
19.9%
36/181 • Number of events 40 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
22.7%
41/181 • Number of events 44 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.5%
10/181 • Number of events 11 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.6%
12/181 • Number of events 14 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.5%
10/181 • Number of events 10 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
6.6%
12/181 • Number of events 12 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.5%
10/181 • Number of events 12 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
6.1%
11/181 • Number of events 13 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
9.9%
18/181 • Number of events 19 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.4%
26/181 • Number of events 28 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
8.3%
15/181 • Number of events 21 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Vascular disorders
Hypertension
|
7.2%
13/181 • Number of events 15 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Vascular disorders
Hypotension
|
6.6%
12/181 • Number of events 12 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
General disorders
Chills
|
7.7%
14/181 • Number of events 15 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
General disorders
Fatigue
|
43.6%
79/181 • Number of events 93 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
General disorders
Non-cardiac chest pain
|
6.1%
11/181 • Number of events 11 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
General disorders
Oedema peripheral
|
7.7%
14/181 • Number of events 19 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
General disorders
Pain
|
5.5%
10/181 • Number of events 13 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
General disorders
Pyrexia
|
13.8%
25/181 • Number of events 26 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Investigations
Weight increased
|
5.5%
10/181 • Number of events 10 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.5%
10/181 • Number of events 10 • Adverse events: From first study dose of atezolizumab until 90 days after the last study dose of atezolizumab (up to 18 months); All-cause mortality: From first dose of study treatment until end of follow-up (up to 59 months)
Safety population included all enrolled NSCLC participants who have received any dose of study drug.
|
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