Study to Assess Safety and Efficacy of Atezolizumab (MPDL... | NCT02486718

ID	Type	Description	Link
2014-003205-15	EudraCT Number
2023-505981-26-00	Registry Identifier	CTIS (EU)

Label	Type	Description	Intervention Names
Atezolizumab	Experimental	Enrollment Phase: Participants will receive four 21-day cycles of cisplatin-based chemotherapy (cisplatin plus either vinorelbine or docetaxel or gemcitabine or pemetrexed [non-squamous cell NSCLC only]), unless unacceptable toxicity, disease relapse, or participant's decision to discontinue occur. Randomization Phase: Participants will receive atezolizumab 1200 milligrams (mg) intravenously (IV) every 3 weeks (Q3W) for sixteen 21-day cycles and will undergo periodic chest X-ray and CT scan.	Drug: Atezolizumab Drug: Cisplatin Drug: Vinorelbine Drug: Docetaxel Drug: Gemcitabine Drug: Pemetrexed
Best Supportive Care	Active Comparator	Enrollment Phase: Participants will receive four 21-day cycles of cisplatin-based chemotherapy (cisplatin plus either vinorelbine or docetaxel or gemcitabine or pemetrexed [non-squamous cell NSCLC only]), unless unacceptable toxicity, disease relapse, or participant's decision to discontinue occur. Randomization Phase: After enrollment phase participants will receive only the best supportive care and will undergo periodic chest X-ray and CT scan.	Drug: Cisplatin Drug: Vinorelbine Drug: Docetaxel Drug: Gemcitabine Drug: Pemetrexed

Name	Type	Description	Arm Group Labels	Other Names
Atezolizumab	Drug	Participants will receive atezolizumab (1200 mg IV) Q3W for 16 cycles (cycle length=21 days).	Atezolizumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Disease-Free Survival (DFS) in Intent-to-treat (ITT) Population	DFS was defined as the time from randomization to the first recurrence of NSCLC or occurrence of new primary NSCLC as determined by the investigator or death, whichever occurs first. Kaplan-Meier methodology was used to estimate the median DFS for each treatment arm.	Up to 95 months
DFS in All Randomized Stage II-IIIA Population	DFS was defined as the time from randomization to the first recurrence of NSCLC or occurrence of new primary NSCLC as determined by the investigator or death, whichever occurs first. DFS was analyzed in participants with disease stage II-IIIA. Kaplan-Meier methodology was used to estimate the median DFS for each treatment arm.	Up to 95 months
DFS in the Programmed Death-ligand 1 (PD-L1) SP263 ≥ 1% Tumor Cell (TC) Subpopulation Within the Stage II-IIIA Population	DFS was defined as the time from randomization to the first recurrence of NSCLC or occurrence of new primary NSCLC as determined by the investigator or death, whichever occurs first. DFS was analyzed in PD-L1 ≥1% subpopulation within the Stage II-IIIA population. Kaplan-Meier methodology was used to estimate the median DFS for each treatment arm.	Up to 95 months

Secondary Outcomes

Measure	Description	Time Frame
Overall Survival (OS) in the ITT Population	OS was defined as the time from randomization to death from any cause.	Baseline up to death from any cause (up to approximately 126 months)
Disease-free Rate at Year 3 in ITT Population

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Inclusion Criteria for Enrollment Phase

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Histological or cytological diagnosis of Stage IB (tumors greater than or equal to [>/=] 4 centimeters [cm])-IIIA (T2-3 N0, T1-3 N1, T1-3 N2, T4 N0-1) NSCLC (per the Union Internationale Contre le Cancer staging system (UICC)/American Joint Committee on Cancer staging system (AJCC) staging system, 7th edition; Detterbeck et al. 2009)
Participants must have had complete resection of NSCLC 4-12 weeks (>/=28 days and less than or equal to [</=] 84 days) prior to enrollment and must be adequately recovered from surgery
If mediastinoscopy was not performed preoperatively, it is required that, at a minimum, mediastinal lymph node systematic sampling will have occurred. Systematic sampling is defined as removal of at least one representative lymph node at specified levels. MLND entails resection of all lymph nodes at those same levels. For a right thoracotomy, sampling or MLND is required at levels 4 and 7 and for a left thoracotomy, levels 5 and/or 6 and 7. Exceptions will be granted if there is clear documentation in the operative report or in a separately submitted addendum by the surgeon of exploration of the required lymph node areas, the participant will be considered eligible if no lymph nodes are found in those areas; if participants have documented N2 disease in one level (per the UICC/AJCC staging system, 7th edition; Detterbeck et al. 2009), not all levels need to be sampled; if the preoperative staging imaging results (contrast computed tomography [CT] and positron emission tomography [PET] scans) do not suggest evidence of disease in the mediastinum, the participant will be considered eligible if N2 nodal sampling is not performed per surgeon's decision
Eligible to receive a cisplatin-based chemotherapy regimen
Adequate hematologic and end-organ function
Women who are not postmenopausal (>/=12 months of non-therapy-induced amenorrhea) or surgically sterile must have a negative serum pregnancy test result within 14 days prior to initiation of cisplatin-based chemotherapy

Inclusion Criteria for Randomized Phase - Women who are not postmenopausal (>/=12 months of non-therapy-induced amenorrhea) or surgically sterile must have a negative serum pregnancy test result within 14 days prior to initiation of atezolizumab or BSC

Exclusion Criteria:

Exclusion Criteria for Enrollment Phase

Illness or condition that may interfere with a participant's capacity to understand, follow, and/or comply with study procedures
Pregnant and lactating women
Treatment with prior systemic chemotherapy: Chemotherapy for early stage of malignancy with curative intent, provided that the last dose received was more than 5 years prior to enrollment and low-dose chemotherapy for non-malignant conditions may be allowed upon approval by the Medical Monitor
Hormonal cancer therapy or radiation therapy as prior cancer treatment within 5 years before enrollment
Treatment with any other investigational agent with therapeutic intent within 28 days prior to enrollment
Participants with hearing impairment
Known sensitivity to any component of the chemotherapy regimen the participant will be assigned to, or to mannitol
Prior treatment with cluster of differentiation (CD) 137 (CD137) agonists or immune checkpoint blockade therapies, anti-programmed death-1 (PD-1), and anti programmed death ligand 1 (PD-L1) therapeutic antibodies
Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death (e.g., expected 5-year OS greater than [>] 90 percent [%]) treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ treated surgically with curative intent)
History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation
History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis
Positive test for human immunodeficiency virus (HIV)
Participants with active hepatitis B (chronic or acute; defined as having a positive hepatitis B surface antigen [HBsAg] test at screening) or hepatitis C
Active tuberculosis
Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction, or cerebrovascular accident within the previous 3 months, unstable arrhythmias, or unstable angina
History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan
Prior allogeneic bone marrow transplantation or solid organ transplant
Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the participant at high risk from treatment complications
Known tumor PD-L1 expression status as determined by an immunohistochemistry (IHC) assay from other clinical studies (e.g., participants whose PD-L1 expression status was determined during screening for entry into a study with anti-PD-1 or anti-PD-L1 antibodies but were not eligible are excluded)

Specific Exclusions for Pemetrexed Treatment

- Participants with squamous cell histology

Exclusion Criteria for Randomized Phase

Signs or symptoms of infection within 14 days prior to randomization (severe infection within 28 days prior to randomization), including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
Received therapeutic oral or intravenous (IV) antibiotics within 14 days prior to randomization
Major surgical procedure within 28 days prior to randomization or anticipation of need for a major surgical procedure during the course of the study
Administration of a live, attenuated vaccine within 4 weeks prior to initiation of study treatment or anticipation that such a live attenuated vaccine will be required during the study
Treatment with systemic immunostimulatory agents (including but not limited to interferons or interleukin-2) within 4 weeks or 5 half-lives of the drug, whichever is longer, prior to randomization: Prior treatment with cancer vaccines is allowed
Treatment with systemic corticosteroids or other immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 14 days prior to randomization

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Highlands Oncology Group		Fayetteville	Arkansas	72703	United States
California Cancer Associates for Research & Excellence, Inc.

PubMed Identifier	Type	Citation	Retractions
41416818	Derived	Okada M, Sugawara S, Watanabe Y, Saito H, Chen-Yoshikawa TF, Goto Y, Nishio W, Nakagawa S, Hayashi M, Kenmotsu H. IMpower010: 5-Year Outcomes of Atezolizumab in Japanese Patients With Resected Stage IB-IIIA Non-Small Cell Lung Cancer. Cancer Sci. 2026 Mar;117(3):749-758. doi: 10.1111/cas.70297. Epub 2025 Dec 19.
40446184	Derived

ID	Title	Description
FG000	Enrollment Phase	All participants received up to four 21-day cycles of cisplatin-based chemotherapy (cisplatin plus either vinorelbine or docetaxel or gemcitabine or pemetrexed [non-squamous cell NSCLC only] based on investigator's choice), unless unacceptable toxicity, disease relapse, or participant's decision to discontinue occurred.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	May 24, 2024	Dec 12, 2024

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Disease-Free Survival (DFS) in Intent-to-treat (ITT) Population

DFS was defined as the time from randomization to the first recurrence of NSCLC or occurrence of new primary NSCLC as determined by the investigator or death, whichever occurs first. Kaplan-Meier methodology was used to estimate the median DFS for each treatment arm.

Randomized ITT population was defined as all randomized participants with resected Stage IB [tumors ≥ 4 centimetres (cm)]-IIIA NSCLC whether or not the participant received the assigned treatment.

Posted

Median

95% Confidence Interval

months

Up to 95 months

ID	Title	Description
OG000	Atezolizumab	Participants who did not experience disease recurrence after chemotherapy in enrollment phase received 1200 milligrams (mg) of atezolizumab intravenously (IV) every 3 weeks (Q3W) for sixteen 21-day cycles in the randomization phase.
OG001	Best Supportive Care (BSC)	Participants who did not experience disease recurrence after chemotherapy in enrollment phase received no treatment in the randomization phase BSC arm.

Units	Counts
Participants	OG000507 OG001498

Title

Denominators

Categories

Title	Measurements
	OG00065.6(52.4 to NA)The upper limit of the 95% confidence interval (CI) was not estimable due to insufficient number of participants with events. OG00147.8(37.0 to 65.8)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Log Rank		0.0683		Hazard Ratio (HR)	0.848			2-Sided	95	0.710	1.013					Superiority	Stratified Analysis

Primary

DFS in All Randomized Stage II-IIIA Population

DFS was defined as the time from randomization to the first recurrence of NSCLC or occurrence of new primary NSCLC as determined by the investigator or death, whichever occurs first. DFS was analyzed in participants with disease stage II-IIIA. Kaplan-Meier methodology was used to estimate the median DFS for each treatment arm.

Stage II-IIIA population was defined as all randomized participants with extent of disease as either Stage II or Stage IIIA, and is a subset of the ITT population. Randomized ITT population was defined as all randomized participants with resected Stage IB (tumors ≥ 4 cm)-IIIA NSCLC whether or not the participant received the assigned treatment.

Posted

Median

95% Confidence Interval

months

Up to 95 months

ID	Title	Description
OG000	Atezolizumab	Participants who did not experience disease recurrence after chemotherapy in enrollment phase received 1200 milligrams (mg) of atezolizumab intravenously (IV) every 3 weeks (Q3W) for sixteen 21-day cycles in the randomization phase.
OG001	Best Supportive Care (BSC)	Participants who did not experience disease recurrence after chemotherapy in enrollment phase received no treatment in the randomization phase BSC arm.

Primary

DFS in the Programmed Death-ligand 1 (PD-L1) SP263 ≥ 1% Tumor Cell (TC) Subpopulation Within the Stage II-IIIA Population

DFS was defined as the time from randomization to the first recurrence of NSCLC or occurrence of new primary NSCLC as determined by the investigator or death, whichever occurs first. DFS was analyzed in PD-L1 ≥1% subpopulation within the Stage II-IIIA population. Kaplan-Meier methodology was used to estimate the median DFS for each treatment arm.

PD-L1 subpopulation, defined as ≥1% TC expression by the SP263 immunohistochemistry (IHC) assay, included Stage II-IIIA population with valid PD-L1 SP263 measurement at baseline. Stage II-IIIA population included all randomized participants with extent of disease as either Stage II or Stage III, & is a subset of ITT population. Randomized ITT population included all randomized participants with resected Stage IB (tumors ≥ 4 cm)-IIIA NSCLC whether the participant received the assigned treatment.

Posted

Median

95% Confidence Interval

months

Up to 95 months

ID	Title	Description
OG000	Atezolizumab	Participants who did not experience disease recurrence after chemotherapy in enrollment phase received 1200 milligrams (mg) of atezolizumab intravenously (IV) every 3 weeks (Q3W) for sixteen 21-day cycles in the randomization phase.
OG001	Best Supportive Care (BSC)	Participants who did not experience disease recurrence after chemotherapy in enrollment phase received no treatment in the randomization phase BSC arm.

Secondary

Overall Survival (OS) in the ITT Population

OS was defined as the time from randomization to death from any cause.

Not Posted

Aug 2028

Baseline up to death from any cause (up to approximately 126 months)

Participants

Secondary

Disease-free Rate at Year 3 in ITT Population

DFS rate was defined as percentage of participants who were disease-free at Year 3. The DFS rate was estimated by the Kaplan-Meier methodology for each treatment arm. Percentages have been rounded off to the nearest decimal.

Randomized ITT population was defined as all randomized participants with resected Stage IB (tumors ≥ 4 cm)-IIIA NSCLC whether or not the participant received the assigned treatment.

Posted

Number

95% Confidence Interval

percentage of participants

Year 3

ID	Title	Description
OG000	Atezolizumab	Participants who did not experience disease recurrence after chemotherapy in enrollment phase received 1200 milligrams (mg) of atezolizumab intravenously (IV) every 3 weeks (Q3W) for sixteen 21-day cycles in the randomization phase.
OG001	Best Supportive Care (BSC)	Participants who did not experience disease recurrence after chemotherapy in enrollment phase received no treatment in the randomization phase BSC arm.

Units	Counts
Participants

Secondary

Disease-free Rate at Year 3 in All Randomized Stage II-IIIA Population

DFS rate was defined as percentage of participants who were disease-free at Year 3. DFS rate was analyzed in participants with disease stage II-IIIA. The DFS rate was estimated by the Kaplan-Meier methodology for each treatment arm. Percentages have been rounded off to the nearest decimal.

Stage II-IIIA population was defined as all randomized participants with extent of disease as either Stage II or Stage III, and is a subset of the ITT population. Randomized ITT population was defined as all randomized participants with resected Stage IB (tumors ≥ 4 cm)-IIIA NSCLC whether or not the participant received the assigned treatment.

Posted

Number

95% Confidence Interval

percentage of participants

Year 3

ID	Title	Description
OG000	Atezolizumab	Participants who did not experience disease recurrence after chemotherapy in enrollment phase received 1200 milligrams (mg) of atezolizumab intravenously (IV) every 3 weeks (Q3W) for sixteen 21-day cycles in the randomization phase.
OG001	Best Supportive Care (BSC)	Participants who did not experience disease recurrence after chemotherapy in enrollment phase received no treatment in the randomization phase BSC arm.

Secondary

Disease-free Rate at Year 3 in PD-L1 (SP263 ≥ 1% TC) Subpopulation Within the Stage II-IIIA Population

DFS rate was defined as percentage of participants who were disease-free at Year 3. DFS rate was analyzed in PD-L1 subpopulation within the Stage II-IIIA population. The DFS rate was estimated by the Kaplan-Meier methodology for each treatment arm. Percentages have been rounded off to the nearest decimal.

PD-L1 subpopulation, defined as ≥ 1% TC expression by the SP263 IHC assay, included Stage II-IIIA population with valid PD-L1 SP263 measurement at baseline. Stage II-IIIA population included all randomized participants with extent of disease as either Stage II or Stage III, & is a subset of ITT population. Randomized ITT population included all randomized participants with resected Stage IB (tumors ≥ 4 cm)-IIIA NSCLC whether the participant received the assigned treatment.

Posted

Number

95% Confidence Interval

percentage of participants

Year 3

ID	Title	Description
OG000	Atezolizumab	Participants who did not experience disease recurrence after chemotherapy in enrollment phase received 1200 milligrams (mg) of atezolizumab intravenously (IV) every 3 weeks (Q3W) for sixteen 21-day cycles in the randomization phase.
OG001	Best Supportive Care (BSC)	Participants who did not experience disease recurrence after chemotherapy in enrollment phase received no treatment in the randomization phase BSC arm.

Secondary

Disease-free Rate at Year 5 in ITT Population

DFS rate was defined as percentage of participants who were disease-free at Year 5. The DFS rate was estimated by the Kaplan-Meier methodology for each treatment arm. Percentages have been rounded off to the nearest decimal.

Randomized ITT population was defined as all randomized participants with resected Stage IB (tumors ≥ 4 cm)-IIIA NSCLC whether or not the participant received the assigned treatment.

Posted

Number

95% Confidence Interval

percentage of participants

Year 5

ID	Title	Description
OG000	Atezolizumab	Participants who did not experience disease recurrence after chemotherapy in enrollment phase received 1200 milligrams (mg) of atezolizumab intravenously (IV) every 3 weeks (Q3W) for sixteen 21-day cycles in the randomization phase.
OG001	Best Supportive Care (BSC)	Participants who did not experience disease recurrence after chemotherapy in enrollment phase received no treatment in the randomization phase BSC arm.

Units	Counts
Participants

Secondary

Disease-free Rate at Year 5 in All Randomized Stage II-IIIA Population

DFS rate was defined as percentage of participants who were disease-free at Year 5. DFS rate was analyzed in participants with disease stage II-IIIA. The DFS rate was estimated by the Kaplan-Meier methodology for each treatment arm. Percentages have been rounded off to the nearest decimal.

Posted

Number

95% Confidence Interval

percentage of participants

Year 5

ID	Title	Description
OG000	Atezolizumab	Participants who did not experience disease recurrence after chemotherapy in enrollment phase received 1200 milligrams (mg) of atezolizumab intravenously (IV) every 3 weeks (Q3W) for sixteen 21-day cycles in the randomization phase.
OG001	Best Supportive Care (BSC)	Participants who did not experience disease recurrence after chemotherapy in enrollment phase received no treatment in the randomization phase BSC arm.

Secondary

Disease-free Rate at Year 5 in PD-L1 (SP263 ≥ 1% TC) Subpopulation Within the Stage II-IIIA Population

DFS rate was defined as percentage of participants who were disease-free at Year 5. DFS rate was analyzed in PD-L1 subpopulation within the Stage II-IIIA population. The DFS rate was estimated by the Kaplan-Meier methodology for each treatment arm. Percentages have been rounded off to the nearest decimal.

Posted

Number

95% Confidence Interval

percentage of participants

Year 5

ID	Title	Description
OG000	Atezolizumab	Participants who did not experience disease recurrence after chemotherapy in enrollment phase received 1200 milligrams (mg) of atezolizumab intravenously (IV) every 3 weeks (Q3W) for sixteen 21-day cycles in the randomization phase.
OG001	Best Supportive Care (BSC)	Participants who did not experience disease recurrence after chemotherapy in enrollment phase received no treatment in the randomization phase BSC arm.

Secondary

DFS in the PD-L1 (SP263 ≥ 50% TC) Subpopulation Within the Stage II-IIIA Population

DFS was defined as the time from randomization to the first recurrence of NSCLC or occurrence of new primary NSCLC as determined by the investigator or death, whichever occurs first. DFS was analyzed in PD-L1 subpopulation within the Stage II-IIIA population. Kaplan-Meier methodology was used to estimate the median DFS for each treatment arm.

PD-L1 subpopulation, defined as ≥50% TC expression by the SP263 IHC assay, included Stage II-IIIA population with valid PD-L1 SP263 measurement at baseline. Stage II-IIIA population included all randomized participants with extent of disease as either Stage II or Stage III, & is a subset of ITT population. Randomized ITT population included all randomized participants with resected Stage IB (tumors ≥ 4 cm)-IIIA NSCLC whether the participant received the assigned treatment.

Posted

Median

95% Confidence Interval

months

Up to 95 months

ID	Title	Description
OG000	Atezolizumab	Participants who did not experience disease recurrence after chemotherapy in enrollment phase received 1200 milligrams (mg) of atezolizumab intravenously (IV) every 3 weeks (Q3W) for sixteen 21-day cycles in the randomization phase.
OG001	Best Supportive Care (BSC)	Participants who did not experience disease recurrence after chemotherapy in enrollment phase received no treatment in the randomization phase BSC arm.

Secondary

Percentage of Participants With Adverse Events (AEs)

An AE is any untoward medical occurrence in a participant when administered a pharmaceutical product regardless of the causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product.

Not Posted

Aug 2028

Up to 12 years

Participants

Secondary

Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab

The percentage of ATA (Also called anti-drug antibodies (ADA))-positive participants after drug administration were determined for participants exposed to atezolizumab. For determining post-baseline incidence, participants were considered to be ADA-positive if they were ADA-negative or had missing data at baseline but developed an ADA response following study drug exposure, or if they were ADA-positive at baseline and the titer of 1 or more post-baseline samples was at least 0.60 titer units (t.u.) greater than the baseline titer result.

ADA evaluable population was defined as all randomized participants who received at least one dose of atezolizumab and who have at least one post-baseline ADA result.

Posted

Number

percentage of participants

Predose (Hour 0) on Day 1 of Cycles 2, 3, 4, 8, 16 (Cycle length = 21 days), at treatment discontinuation (TD) (up to 12 months), 120 days after last atezolizumab administration (up to 16 months)

ID	Title	Description
OG000	Atezolizumab	Participants who did not experience disease recurrence after chemotherapy in enrollment phase received 1200 milligrams (mg) of atezolizumab intravenously (IV) every 3 weeks (Q3W) for sixteen 21-day cycles in the randomization phase.

Units	Counts
Participants

Secondary

Maximum Plasma Concentration (Cmax) of Atezolizumab

PK-evaluable population was defined as all randomized participants who received any dose of the study treatment and who have evaluable pharmacokinetic samples. Overall number analyzed is the number of participants with data available for analysis.

Posted

Geometric Mean

Geometric Coefficient of Variation

micrograms/millilitres (μg/ml)

30 min post-infusion on Day 1 of Cycle 1 (Cycle length = 21 days)

ID	Title	Description
OG000	Atezolizumab	Participants who did not experience disease recurrence after chemotherapy in enrollment phase received 1200 milligrams (mg) of atezolizumab intravenously (IV) every 3 weeks (Q3W) for sixteen 21-day cycles in the randomization phase.

Units	Counts
Participants	OG000

Secondary

Minimum Serum Concentration (Cmin) at Steady-State Within a Dosing Interval of Atezolizumab

PK-evaluable population was defined as all randomized participants who received any dose of the study treatment and who have evaluable pharmacokinetic samples. Number analyzed is the number of participants with data available for analyses at the specified timepoints.

Posted

Geometric Mean

Geometric Coefficient of Variation

μg/ml

Prior to infusion on Day 1 of Cycles 1, 2, 3, 4, 8, 16 (Cycle length = 21 days), at study discontinuation visit (up to 12 months), Day 120 post last dose of atezolizumab (up to 16 months)

ID	Title	Description
OG000	Atezolizumab	Participants who did not experience disease recurrence after chemotherapy in enrollment phase received 1200 milligrams (mg) of atezolizumab intravenously (IV) every 3 weeks (Q3W) for sixteen 21-day cycles in the randomization phase.

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA version 26.1	Systematic Assessment	EG0008 events8 affected1,269 at risk EG0010 events0 affected495 at risk EG0021 events1 affected495 at risk
Sarcoidosis of lymph node	Blood and lymphatic system disorders	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0010 events0 affected495 at risk EG0021 events1 affected495 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA version 26.1	Systematic Assessment	EG0002 events2 affected1,269 at risk EG0011 events1 affected495 at risk EG0020 events0 affected495 at risk
Arrhythmia	Cardiac disorders	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0010 events0 affected495 at risk EG0021 events1 affected495 at risk
Atrial fibrillation	Cardiac disorders	MedDRA version 26.1	Systematic Assessment	EG0002 events2 affected1,269 at risk EG0010 events0 affected495 at risk EG0022 events2 affected495 at risk
Cardiac arrest	Cardiac disorders	MedDRA version 26.1	Systematic Assessment	EG0001 events1 affected1,269 at risk EG0010 events0 affected495 at risk EG0021 events1 affected495 at risk
Cardiac failure acute	Cardiac disorders	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0010 events0 affected495 at risk EG0021 events1 affected495 at risk
Cardiac tamponade	Cardiac disorders	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0011 events1 affected495 at risk EG0020 events0 affected495 at risk
Myocardial infarction	Cardiac disorders	MedDRA version 26.1	Systematic Assessment	EG0002 events2 affected1,269 at risk EG0011 events1 affected495 at risk EG0021 events1 affected495 at risk
Myocarditis	Cardiac disorders	MedDRA version 26.1	Systematic Assessment	EG0001 events1 affected1,269 at risk EG0010 events0 affected495 at risk EG0021 events1 affected495 at risk
Pericardial effusion	Cardiac disorders	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0011 events1 affected495 at risk EG0020 events0 affected495 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0010 events0 affected495 at risk EG0021 events1 affected495 at risk
Vertigo	Ear and labyrinth disorders	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0010 events0 affected495 at risk EG0021 events1 affected495 at risk
Adrenal insufficiency	Endocrine disorders	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0010 events0 affected495 at risk EG0021 events1 affected495 at risk
Hypopituitarism	Endocrine disorders	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0010 events0 affected495 at risk EG0021 events1 affected495 at risk
Inappropriate antidiuretic hormone secretion	Endocrine disorders	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0010 events0 affected495 at risk EG0021 events1 affected495 at risk
Secondary adrenocortical insufficiency	Endocrine disorders	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0010 events0 affected495 at risk EG0021 events1 affected495 at risk
Retinal detachment	Eye disorders	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0011 events1 affected495 at risk EG0020 events0 affected495 at risk
Vitreous haemorrhage	Eye disorders	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0011 events1 affected495 at risk EG0020 events0 affected495 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0011 events1 affected495 at risk EG0020 events0 affected495 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0011 events1 affected495 at risk EG0021 events1 affected495 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA version 26.1	Systematic Assessment	EG0005 events5 affected1,269 at risk EG0010 events0 affected495 at risk EG0021 events1 affected495 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0010 events0 affected495 at risk EG0021 events1 affected495 at risk
Food poisoning	Gastrointestinal disorders	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0011 events1 affected495 at risk EG0020 events0 affected495 at risk
Gastritis	Gastrointestinal disorders	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0010 events0 affected495 at risk EG0021 events1 affected495 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0012 events2 affected495 at risk EG0020 events0 affected495 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0011 events1 affected495 at risk EG0020 events0 affected495 at risk
Chest pain	General disorders	MedDRA version 26.1	Systematic Assessment	EG0001 events1 affected1,269 at risk EG0011 events1 affected495 at risk EG0020 events0 affected495 at risk
Death	General disorders	MedDRA version 26.1	Systematic Assessment	EG0003 events3 affected1,269 at risk EG0010 events0 affected495 at risk EG0021 events1 affected495 at risk
General physical health deterioration	General disorders	MedDRA version 26.1	Systematic Assessment	EG0003 events3 affected1,269 at risk EG0011 events1 affected495 at risk EG0021 events1 affected495 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0010 events0 affected495 at risk EG0021 events1 affected495 at risk
Oedema peripheral	General disorders	MedDRA version 26.1	Systematic Assessment	EG0001 events1 affected1,269 at risk EG0010 events0 affected495 at risk EG0021 events1 affected495 at risk
Pyrexia	General disorders	MedDRA version 26.1	Systematic Assessment	EG0002 events2 affected1,269 at risk EG0011 events1 affected495 at risk EG0026 events6 affected495 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA version 26.1	Systematic Assessment	EG0001 events1 affected1,269 at risk EG0010 events0 affected495 at risk EG0022 events1 affected495 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA version 26.1	Systematic Assessment	EG0001 events1 affected1,269 at risk EG0011 events1 affected495 at risk EG0020 events0 affected495 at risk
Cholestasis	Hepatobiliary disorders	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0011 events1 affected495 at risk EG0020 events0 affected495 at risk
Drug-induced liver injury	Hepatobiliary disorders	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0010 events0 affected495 at risk EG0022 events2 affected495 at risk
Hepatitis	Hepatobiliary disorders	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0010 events0 affected495 at risk EG0022 events2 affected495 at risk
Anaphylactic reaction	Immune system disorders	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0010 events0 affected495 at risk EG0021 events1 affected495 at risk
Contrast media reaction	Immune system disorders	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0011 events1 affected495 at risk EG0020 events0 affected495 at risk
Hypersensitivity	Immune system disorders	MedDRA version 26.1	Systematic Assessment	EG0002 events2 affected1,269 at risk EG0010 events0 affected495 at risk EG0021 events1 affected495 at risk
Immune-mediated adverse reaction	Immune system disorders	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0010 events0 affected495 at risk EG0021 events1 affected495 at risk
Sarcoidosis	Immune system disorders	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0010 events0 affected495 at risk EG0021 events1 affected495 at risk
Abscess limb	Infections and infestations	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0010 events0 affected495 at risk EG0021 events1 affected495 at risk
Appendicitis	Infections and infestations	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0011 events1 affected495 at risk EG0020 events0 affected495 at risk
Biliary tract infection	Infections and infestations	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0011 events1 affected495 at risk EG0020 events0 affected495 at risk
Bronchitis	Infections and infestations	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0010 events0 affected495 at risk EG0021 events1 affected495 at risk
Cellulitis	Infections and infestations	MedDRA version 26.1	Systematic Assessment	EG0001 events1 affected1,269 at risk EG0010 events0 affected495 at risk EG0022 events1 affected495 at risk
Device related infection	Infections and infestations	MedDRA version 26.1	Systematic Assessment	EG0001 events1 affected1,269 at risk EG0010 events0 affected495 at risk EG0021 events1 affected495 at risk
Encephalitis	Infections and infestations	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0010 events0 affected495 at risk EG0021 events1 affected495 at risk
Enterocolitis infectious	Infections and infestations	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0010 events0 affected495 at risk EG0021 events1 affected495 at risk
Influenza	Infections and infestations	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0010 events0 affected495 at risk EG0021 events1 affected495 at risk
Laryngitis	Infections and infestations	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0010 events0 affected495 at risk EG0021 events1 affected495 at risk
Meningitis	Infections and infestations	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0010 events0 affected495 at risk EG0022 events2 affected495 at risk
Otitis media chronic	Infections and infestations	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0011 events1 affected495 at risk EG0020 events0 affected495 at risk
Pleural infection	Infections and infestations	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0011 events1 affected495 at risk EG0020 events0 affected495 at risk
Pneumonia	Infections and infestations	MedDRA version 26.1	Systematic Assessment	EG00018 events18 affected1,269 at risk EG0015 events5 affected495 at risk EG0029 events8 affected495 at risk
Pneumonia pneumococcal	Infections and infestations	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0010 events0 affected495 at risk EG0021 events1 affected495 at risk
Respiratory tract infection	Infections and infestations	MedDRA version 26.1	Systematic Assessment	EG0003 events3 affected1,269 at risk EG0011 events1 affected495 at risk EG0021 events1 affected495 at risk
Sepsis	Infections and infestations	MedDRA version 26.1	Systematic Assessment	EG0005 events5 affected1,269 at risk EG0010 events0 affected495 at risk EG0022 events2 affected495 at risk
Septic shock	Infections and infestations	MedDRA version 26.1	Systematic Assessment	EG0002 events2 affected1,269 at risk EG0011 events1 affected495 at risk EG0022 events2 affected495 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0010 events0 affected495 at risk EG0021 events1 affected495 at risk
Tonsillitis	Infections and infestations	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0010 events0 affected495 at risk EG0021 events1 affected495 at risk
Urinary tract infection	Infections and infestations	MedDRA version 26.1	Systematic Assessment	EG0003 events3 affected1,269 at risk EG0010 events0 affected495 at risk EG0022 events2 affected495 at risk
Viral myocarditis	Infections and infestations	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0010 events0 affected495 at risk EG0021 events1 affected495 at risk
Comminuted fracture	Injury, poisoning and procedural complications	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0011 events1 affected495 at risk EG0020 events0 affected495 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0010 events0 affected495 at risk EG0021 events1 affected495 at risk
Forearm fracture	Injury, poisoning and procedural complications	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0011 events1 affected495 at risk EG0020 events0 affected495 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0010 events0 affected495 at risk EG0021 events1 affected495 at risk
Injury	Injury, poisoning and procedural complications	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0010 events0 affected495 at risk EG0021 events1 affected495 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0010 events0 affected495 at risk EG0021 events1 affected495 at risk
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0010 events0 affected495 at risk EG0021 events1 affected495 at risk
Prescribed overdose	Injury, poisoning and procedural complications	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0011 events1 affected495 at risk EG0020 events0 affected495 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0011 events1 affected495 at risk EG0020 events0 affected495 at risk
Urethral stricture traumatic	Injury, poisoning and procedural complications	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0010 events0 affected495 at risk EG0021 events1 affected495 at risk
Blood creatinine increased	Investigations	MedDRA version 26.1	Systematic Assessment	EG0002 events2 affected1,269 at risk EG0010 events0 affected495 at risk EG0021 events1 affected495 at risk
Platelet count decreased	Investigations	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0010 events0 affected495 at risk EG0021 events1 affected495 at risk
Weight decreased	Investigations	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0010 events0 affected495 at risk EG0021 events1 affected495 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA version 26.1	Systematic Assessment	EG0003 events3 affected1,269 at risk EG0010 events0 affected495 at risk EG0021 events1 affected495 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA version 26.1	Systematic Assessment	EG0001 events1 affected1,269 at risk EG0010 events0 affected495 at risk EG0021 events1 affected495 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA version 26.1	Systematic Assessment	EG0002 events2 affected1,269 at risk EG0010 events0 affected495 at risk EG0021 events1 affected495 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0011 events1 affected495 at risk EG0020 events0 affected495 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0010 events0 affected495 at risk EG0021 events1 affected495 at risk
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0010 events0 affected495 at risk EG0021 events1 affected495 at risk
Anal squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0011 events1 affected495 at risk EG0020 events0 affected495 at risk
Intestinal metastasis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0011 events1 affected495 at risk EG0020 events0 affected495 at risk
Langerhans' cell histiocytosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0011 events1 affected495 at risk EG0020 events0 affected495 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0011 events1 affected495 at risk EG0020 events0 affected495 at risk
Squamous cell carcinoma of head and neck	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0011 events1 affected495 at risk EG0020 events0 affected495 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0010 events0 affected495 at risk EG0021 events1 affected495 at risk
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0010 events0 affected495 at risk EG0021 events1 affected495 at risk
Urinary tract neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0011 events1 affected495 at risk EG0020 events0 affected495 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0010 events0 affected495 at risk EG0021 events1 affected495 at risk
Axonal neuropathy	Nervous system disorders	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0010 events0 affected495 at risk EG0021 events1 affected495 at risk
Cerebellar infarction	Nervous system disorders	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0011 events1 affected495 at risk EG0020 events0 affected495 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0010 events0 affected495 at risk EG0022 events1 affected495 at risk
Cerebral infarction	Nervous system disorders	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0010 events0 affected495 at risk EG0021 events1 affected495 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0010 events0 affected495 at risk EG0021 events1 affected495 at risk
Demyelinating polyneuropathy	Nervous system disorders	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0010 events0 affected495 at risk EG0021 events1 affected495 at risk
Encephalitis autoimmune	Nervous system disorders	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0010 events0 affected495 at risk EG0021 events1 affected495 at risk
Encephalopathy	Nervous system disorders	MedDRA version 26.1	Systematic Assessment	EG0001 events1 affected1,269 at risk EG0010 events0 affected495 at risk EG0021 events1 affected495 at risk
Intracranial haematoma	Nervous system disorders	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0010 events0 affected495 at risk EG0021 events1 affected495 at risk
Ischaemic stroke	Nervous system disorders	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0010 events0 affected495 at risk EG0021 events1 affected495 at risk
Loss of consciousness	Nervous system disorders	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0010 events0 affected495 at risk EG0021 events1 affected495 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0010 events0 affected495 at risk EG0022 events2 affected495 at risk
Paraesthesia	Nervous system disorders	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0011 events1 affected495 at risk EG0020 events0 affected495 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0011 events1 affected495 at risk EG0020 events0 affected495 at risk
Syncope	Nervous system disorders	MedDRA version 26.1	Systematic Assessment	EG0005 events5 affected1,269 at risk EG0010 events0 affected495 at risk EG0021 events1 affected495 at risk
Depression	Psychiatric disorders	MedDRA version 26.1	Systematic Assessment	EG0001 events1 affected1,269 at risk EG0013 events2 affected495 at risk EG0020 events0 affected495 at risk
Dissociative disorder	Psychiatric disorders	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0011 events1 affected495 at risk EG0020 events0 affected495 at risk
Hallucination, visual	Psychiatric disorders	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0010 events0 affected495 at risk EG0021 events1 affected495 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA version 26.1	Systematic Assessment	EG0006 events6 affected1,269 at risk EG0010 events0 affected495 at risk EG0021 events1 affected495 at risk
Urinary tract obstruction	Renal and urinary disorders	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0010 events0 affected495 at risk EG0021 events1 affected495 at risk
Adnexal torsion	Reproductive system and breast disorders	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0010 events0 affected495 at risk EG0021 events1 affected495 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0011 events1 affected495 at risk EG0020 events0 affected495 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0010 events0 affected495 at risk EG0021 events1 affected495 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0010 events0 affected495 at risk EG0021 events1 affected495 at risk
Alveolitis	Respiratory, thoracic and mediastinal disorders	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0010 events0 affected495 at risk EG0021 events1 affected495 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA version 26.1	Systematic Assessment	EG0002 events2 affected1,269 at risk EG0010 events0 affected495 at risk EG0023 events2 affected495 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0010 events0 affected495 at risk EG0023 events3 affected495 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0010 events0 affected495 at risk EG0021 events1 affected495 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0010 events0 affected495 at risk EG0025 events4 affected495 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA version 26.1	Systematic Assessment	EG0002 events2 affected1,269 at risk EG0010 events0 affected495 at risk EG0021 events1 affected495 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA version 26.1	Systematic Assessment	EG00022 events22 affected1,269 at risk EG0011 events1 affected495 at risk EG0021 events1 affected495 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA version 26.1	Systematic Assessment	EG0001 events1 affected1,269 at risk EG0012 events2 affected495 at risk EG0020 events0 affected495 at risk
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0010 events0 affected495 at risk EG0021 events1 affected495 at risk
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA version 26.1	Systematic Assessment	EG0000 events0 affected1,269 at risk EG0010 events0 affected495 at risk EG0022 events2 affected495 at risk
Deep vein thrombosis	Vascular disorders	MedDRA version 26.1	Systematic Assessment	EG0003 events3 affected1,269 at risk EG0012 events2 affected495 at risk EG0020 events0 affected495 at risk
Thrombophlebitis	Vascular disorders	MedDRA version 26.1	Systematic Assessment	EG0001 events1 affected1,269 at risk EG0011 events1 affected495 at risk EG0020 events0 affected495 at risk
Agranulocytosis	Blood and lymphatic system disorders	MedDRA version 26.1	Systematic Assessment	EG0001 events1 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Bone marrow failure	Blood and lymphatic system disorders	MedDRA version 26.1	Systematic Assessment	EG0001 events1 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Febrile bone marrow aplasia	Blood and lymphatic system disorders	MedDRA version 26.1	Systematic Assessment	EG0002 events2 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA version 26.1	Systematic Assessment	EG00042 events38 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA version 26.1	Systematic Assessment	EG0001 events1 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Myelosuppression	Blood and lymphatic system disorders	MedDRA version 26.1	Systematic Assessment	EG0002 events2 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA version 26.1	Systematic Assessment	EG00014 events13 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA version 26.1	Systematic Assessment	EG0002 events1 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA version 26.1	Systematic Assessment	EG0003 events3 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Angina pectoris	Cardiac disorders	MedDRA version 26.1	Systematic Assessment	EG0001 events1 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA version 26.1	Systematic Assessment	EG0001 events1 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Coronary artery disease	Cardiac disorders	MedDRA version 26.1	Systematic Assessment	EG0001 events1 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Sinus tachycardia	Cardiac disorders	MedDRA version 26.1	Systematic Assessment	EG0001 events1 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Tachycardia	Cardiac disorders	MedDRA version 26.1	Systematic Assessment	EG0001 events1 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Ventricular arrhythmia	Cardiac disorders	MedDRA version 26.1	Systematic Assessment	EG0001 events1 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Otolithiasis	Ear and labyrinth disorders	MedDRA version 26.1	Systematic Assessment	EG0001 events1 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA version 26.1	Systematic Assessment	EG0002 events2 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Colitis	Gastrointestinal disorders	MedDRA version 26.1	Systematic Assessment	EG0002 events2 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Constipation	Gastrointestinal disorders	MedDRA version 26.1	Systematic Assessment	EG0002 events2 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA version 26.1	Systematic Assessment	EG0001 events1 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Gastrointestinal inflammation	Gastrointestinal disorders	MedDRA version 26.1	Systematic Assessment	EG0001 events1 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Ileus paralytic	Gastrointestinal disorders	MedDRA version 26.1	Systematic Assessment	EG0002 events2 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA version 26.1	Systematic Assessment	EG0002 events1 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Large intestinal obstruction	Gastrointestinal disorders	MedDRA version 26.1	Systematic Assessment	EG0001 events1 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Nausea	Gastrointestinal disorders	MedDRA version 26.1	Systematic Assessment	EG00012 events12 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA version 26.1	Systematic Assessment	EG0001 events1 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Proctitis	Gastrointestinal disorders	MedDRA version 26.1	Systematic Assessment	EG0001 events1 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Varices oesophageal	Gastrointestinal disorders	MedDRA version 26.1	Systematic Assessment	EG0001 events1 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Vomiting	Gastrointestinal disorders	MedDRA version 26.1	Systematic Assessment	EG00012 events10 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Asthenia	General disorders	MedDRA version 26.1	Systematic Assessment	EG0002 events2 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Device related thrombosis	General disorders	MedDRA version 26.1	Systematic Assessment	EG0001 events1 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Fatigue	General disorders	MedDRA version 26.1	Systematic Assessment	EG0002 events2 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Malaise	General disorders	MedDRA version 26.1	Systematic Assessment	EG0006 events4 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Pain	General disorders	MedDRA version 26.1	Systematic Assessment	EG0001 events1 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Performance status decreased	General disorders	MedDRA version 26.1	Systematic Assessment	EG0001 events1 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA version 26.1	Systematic Assessment	EG0001 events1 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Jaundice	Hepatobiliary disorders	MedDRA version 26.1	Systematic Assessment	EG0001 events1 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Bacteraemia	Infections and infestations	MedDRA version 26.1	Systematic Assessment	EG0001 events1 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Bacterial abdominal infection	Infections and infestations	MedDRA version 26.1	Systematic Assessment	EG0001 events1 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Bacterial diarrhoea	Infections and infestations	MedDRA version 26.1	Systematic Assessment	EG0001 events1 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA version 26.1	Systematic Assessment	EG0002 events2 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Device related sepsis	Infections and infestations	MedDRA version 26.1	Systematic Assessment	EG0002 events2 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Diarrhoea infectious	Infections and infestations	MedDRA version 26.1	Systematic Assessment	EG0001 events1 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Diverticulitis	Infections and infestations	MedDRA version 26.1	Systematic Assessment	EG0001 events1 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Infectious pleural effusion	Infections and infestations	MedDRA version 26.1	Systematic Assessment	EG0002 events2 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Intervertebral discitis	Infections and infestations	MedDRA version 26.1	Systematic Assessment	EG0001 events1 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA version 26.1	Systematic Assessment	EG0001 events1 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Neutropenic sepsis	Infections and infestations	MedDRA version 26.1	Systematic Assessment	EG0002 events2 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Oral candidiasis	Infections and infestations	MedDRA version 26.1	Systematic Assessment	EG0001 events1 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Oral infection	Infections and infestations	MedDRA version 26.1	Systematic Assessment	EG0001 events1 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Pneumonia staphylococcal	Infections and infestations	MedDRA version 26.1	Systematic Assessment	EG0001 events1 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Pulmonary sepsis	Infections and infestations	MedDRA version 26.1	Systematic Assessment	EG0001 events1 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Pulmonary tuberculosis	Infections and infestations	MedDRA version 26.1	Systematic Assessment	EG0001 events1 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Stitch abscess	Infections and infestations	MedDRA version 26.1	Systematic Assessment	EG0001 events1 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA version 26.1	Systematic Assessment	EG0001 events1 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Vascular device infection	Infections and infestations	MedDRA version 26.1	Systematic Assessment	EG0003 events3 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Vascular access complication	Injury, poisoning and procedural complications	MedDRA version 26.1	Systematic Assessment	EG0001 events1 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Alanine aminotransferase increased	Investigations	MedDRA version 26.1	Systematic Assessment	EG0004 events3 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Aspartate aminotransferase increased	Investigations	MedDRA version 26.1	Systematic Assessment	EG0004 events2 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Neutrophil count decreased	Investigations	MedDRA version 26.1	Systematic Assessment	EG00010 events9 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
White blood cell count decreased	Investigations	MedDRA version 26.1	Systematic Assessment	EG0004 events4 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA version 26.1	Systematic Assessment	EG0005 events5 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA version 26.1	Systematic Assessment	EG0002 events2 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA version 26.1	Systematic Assessment	EG0001 events1 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA version 26.1	Systematic Assessment	EG0002 events2 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA version 26.1	Systematic Assessment	EG0001 events1 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA version 26.1	Systematic Assessment	EG0001 events1 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Autonomic neuropathy	Nervous system disorders	MedDRA version 26.1	Systematic Assessment	EG0001 events1 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA version 26.1	Systematic Assessment	EG0002 events2 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Hypotonia	Nervous system disorders	MedDRA version 26.1	Systematic Assessment	EG0001 events1 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Intercostal neuralgia	Nervous system disorders	MedDRA version 26.1	Systematic Assessment	EG0001 events1 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Seizure	Nervous system disorders	MedDRA version 26.1	Systematic Assessment	EG0001 events1 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA version 26.1	Systematic Assessment	EG0001 events1 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Device occlusion	Product Issues	MedDRA version 26.1	Systematic Assessment	EG0001 events1 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Catatonia	Psychiatric disorders	MedDRA version 26.1	Systematic Assessment	EG0001 events1 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Delirium	Psychiatric disorders	MedDRA version 26.1	Systematic Assessment	EG0001 events1 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Panic attack	Psychiatric disorders	MedDRA version 26.1	Systematic Assessment	EG0001 events1 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA version 26.1	Systematic Assessment	EG0001 events1 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Dysuria	Renal and urinary disorders	MedDRA version 26.1	Systematic Assessment	EG0002 events1 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Renal failure	Renal and urinary disorders	MedDRA version 26.1	Systematic Assessment	EG0003 events3 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Bronchial fistula	Respiratory, thoracic and mediastinal disorders	MedDRA version 26.1	Systematic Assessment	EG0001 events1 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Bronchitis chronic	Respiratory, thoracic and mediastinal disorders	MedDRA version 26.1	Systematic Assessment	EG0001 events1 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Bronchopleural fistula	Respiratory, thoracic and mediastinal disorders	MedDRA version 26.1	Systematic Assessment	EG0001 events1 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Chylothorax	Respiratory, thoracic and mediastinal disorders	MedDRA version 26.1	Systematic Assessment	EG0001 events1 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA version 26.1	Systematic Assessment	EG0001 events1 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA version 26.1	Systematic Assessment	EG0002 events2 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA version 26.1	Systematic Assessment	EG0001 events1 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA version 26.1	Systematic Assessment	EG0002 events2 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA version 26.1	Systematic Assessment	EG0001 events1 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Pneumothorax spontaneous	Respiratory, thoracic and mediastinal disorders	MedDRA version 26.1	Systematic Assessment	EG0001 events1 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Pulmonary artery thrombosis	Respiratory, thoracic and mediastinal disorders	MedDRA version 26.1	Systematic Assessment	EG0001 events1 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Pulmonary granuloma	Respiratory, thoracic and mediastinal disorders	MedDRA version 26.1	Systematic Assessment	EG0001 events1 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Subcutaneous emphysema	Skin and subcutaneous tissue disorders	MedDRA version 26.1	Systematic Assessment	EG0001 events1 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Embolism	Vascular disorders	MedDRA version 26.1	Systematic Assessment	EG0004 events4 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Granulomatosis with polyangiitis	Vascular disorders	MedDRA version 26.1	Systematic Assessment	EG0001 events1 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA version 26.1	Systematic Assessment	EG0001 events1 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Subclavian vein thrombosis	Vascular disorders	MedDRA version 26.1	Systematic Assessment	EG0001 events1 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA version 26.1	Systematic Assessment	EG000422 events357 affected1,269 at risk EG00130 events30 affected495 at risk EG00247 events37 affected495 at risk
Hyperthyroidism	Endocrine disorders	MedDRA version 26.1	Systematic Assessment	EG0007 events7 affected1,269 at risk EG0013 events3 affected495 at risk EG00236 events33 affected495 at risk
Hypothyroidism	Endocrine disorders	MedDRA version 26.1	Systematic Assessment	EG0003 events3 affected1,269 at risk EG0013 events3 affected495 at risk EG00261 events54 affected495 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA version 26.1	Systematic Assessment	EG000226 events181 affected1,269 at risk EG00112 events9 affected495 at risk EG00254 events36 affected495 at risk
Nausea	Gastrointestinal disorders	MedDRA version 26.1	Systematic Assessment	EG0001,032 events660 affected1,269 at risk EG00116 events16 affected495 at risk EG00244 events31 affected495 at risk
Asthenia	General disorders	MedDRA version 26.1	Systematic Assessment	EG000301 events234 affected1,269 at risk EG00115 events14 affected495 at risk EG00245 events37 affected495 at risk
Fatigue	General disorders	MedDRA version 26.1	Systematic Assessment	EG000309 events269 affected1,269 at risk EG00114 events11 affected495 at risk EG00241 events33 affected495 at risk
Pyrexia	General disorders	MedDRA version 26.1	Systematic Assessment	EG00086 events75 affected1,269 at risk EG00114 events11 affected495 at risk EG00267 events60 affected495 at risk
Nasopharyngitis	Infections and infestations	MedDRA version 26.1	Systematic Assessment	EG00026 events25 affected1,269 at risk EG00165 events50 affected495 at risk EG00244 events33 affected495 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA version 26.1	Systematic Assessment	EG00033 events27 affected1,269 at risk EG00114 events12 affected495 at risk EG00243 events37 affected495 at risk
Alanine aminotransferase increased	Investigations	MedDRA version 26.1	Systematic Assessment	EG00057 events52 affected1,269 at risk EG00117 events16 affected495 at risk EG00271 events54 affected495 at risk
Aspartate aminotransferase increased	Investigations	MedDRA version 26.1	Systematic Assessment	EG00047 events43 affected1,269 at risk EG00116 events16 affected495 at risk EG00267 events54 affected495 at risk
Blood creatinine increased	Investigations	MedDRA version 26.1	Systematic Assessment	EG000113 events85 affected1,269 at risk EG00115 events15 affected495 at risk EG00236 events29 affected495 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA version 26.1	Systematic Assessment	EG00041 events36 affected1,269 at risk EG00135 events26 affected495 at risk EG00265 events52 affected495 at risk
Headache	Nervous system disorders	MedDRA version 26.1	Systematic Assessment	EG00090 events77 affected1,269 at risk EG00122 events20 affected495 at risk EG00239 events28 affected495 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA version 26.1	Systematic Assessment	EG000101 events93 affected1,269 at risk EG00155 events46 affected495 at risk EG00284 events66 affected495 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA version 26.1	Systematic Assessment	EG00064 events64 affected1,269 at risk EG00133 events32 affected495 at risk EG00235 events31 affected495 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA version 26.1	Systematic Assessment	EG00026 events22 affected1,269 at risk EG0013 events3 affected495 at risk EG00255 events51 affected495 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA version 26.1	Systematic Assessment	EG00058 events54 affected1,269 at risk EG0017 events5 affected495 at risk EG00258 events48 affected495 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA version 26.1	Systematic Assessment	EG000128 events84 affected1,269 at risk EG0016 events5 affected495 at risk EG00210 events5 affected495 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA version 26.1	Systematic Assessment	EG000568 events338 affected1,269 at risk EG0015 events5 affected495 at risk EG00233 events21 affected495 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA version 26.1	Systematic Assessment	EG00094 events67 affected1,269 at risk EG0019 events6 affected495 at risk EG00211 events9 affected495 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA version 26.1	Systematic Assessment	EG00075 events69 affected1,269 at risk EG0016 events6 affected495 at risk EG0028 events6 affected495 at risk
Constipation	Gastrointestinal disorders	MedDRA version 26.1	Systematic Assessment	EG000389 events317 affected1,269 at risk EG00110 events9 affected495 at risk EG00227 events24 affected495 at risk
Vomiting	Gastrointestinal disorders	MedDRA version 26.1	Systematic Assessment	EG000361 events248 affected1,269 at risk EG0019 events9 affected495 at risk EG00227 events20 affected495 at risk
Malaise	General disorders	MedDRA version 26.1	Systematic Assessment	EG00094 events66 affected1,269 at risk EG0012 events2 affected495 at risk EG0025 events5 affected495 at risk
Neutrophil count decreased	Investigations	MedDRA version 26.1	Systematic Assessment	EG000367 events187 affected1,269 at risk EG0013 events3 affected495 at risk EG00210 events9 affected495 at risk
Platelet count decreased	Investigations	MedDRA version 26.1	Systematic Assessment	EG000108 events73 affected1,269 at risk EG0011 events1 affected495 at risk EG00212 events10 affected495 at risk
White blood cell count decreased	Investigations	MedDRA version 26.1	Systematic Assessment	EG000221 events111 affected1,269 at risk EG0011 events1 affected495 at risk EG0027 events6 affected495 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA version 26.1	Systematic Assessment	EG000421 events305 affected1,269 at risk EG0017 events7 affected495 at risk EG00228 events23 affected495 at risk
Dizziness	Nervous system disorders	MedDRA version 26.1	Systematic Assessment	EG00074 events70 affected1,269 at risk EG00115 events15 affected495 at risk EG00220 events18 affected495 at risk
Dysgeusia	Nervous system disorders	MedDRA version 26.1	Systematic Assessment	EG000106 events95 affected1,269 at risk EG0011 events1 affected495 at risk EG0022 events2 affected495 at risk
Insomnia	Psychiatric disorders	MedDRA version 26.1	Systematic Assessment	EG00080 events75 affected1,269 at risk EG0016 events6 affected495 at risk EG00221 events21 affected495 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA version 26.1	Systematic Assessment	EG000142 events89 affected1,269 at risk EG0010 events0 affected495 at risk EG0020 events0 affected495 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA version 26.1	Systematic Assessment	EG000183 events181 affected1,269 at risk EG00110 events10 affected495 at risk EG0026 events6 affected495 at risk

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Term
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017672	Nitrogen Compounds
D017671	Platinum Compounds
D014748	Vinca Alkaloids
D046948	Secologanin Tryptamine Alkaloids
D026121	Indole Alkaloids
D000470	Alkaloids
D006571	Heterocyclic Compounds
D007211	Indoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D054836	Indolizidines
D007212	Indolizines
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D004224	Diterpenes
D013729	Terpenes
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006147	Guanine
D007042	Hypoxanthines
D011688	Purinones
D011687	Purines
D005971	Glutamates
D024342	Amino Acids, Acidic
D000596	Amino Acids
D000602	Amino Acids, Peptides, and Proteins
D000600	Amino Acids, Dicarboxylic

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Enrollment Phase	All participants received up to four 21-day cycles of cisplatin-based chemotherapy (cisplatin plus either vinorelbine or docetaxel or gemcitabine or pemetrexed [non-squamous cell NSCLC only] based on investigator's choice), unless unacceptable toxicity, disease relapse, or participant's decision to discontinue occurred.	19	1,269	259	1,269	1,153	1,269
EG001	Best Supportive Care (BSC)	Participants who did not experience disease recurrence after chemotherapy in enrollment phase received no treatment in the randomization phase BSC arm.	155	495	42	495	227	495
EG002	Atezolizumab	Participants who did not experience disease recurrence after chemotherapy in enrollment phase received 1200 milligrams (mg) of atezolizumab intravenously (IV) every 3 weeks (Q3W) for sixteen 21-day cycles in the randomization phase.	154	495	88	495	358	495

ID	Term
C000594389	atezolizumab
D002945	Cisplatin
D000077235	Vinorelbine
D000077143	Docetaxel
D000093542	Gemcitabine
D000068437	Pemetrexed