## Protocol Section
### Identification Module
**NCT ID:** NCT02763579

**Acronym:** IMpower133

**Brief Title:** A Study of Carboplatin Plus Etoposide With or Without Atezolizumab in Participants With Untreated Extensive-Stage (ES) Small Cell Lung Cancer (SCLC)

**Official Title:** A Phase I/III, Randomized, Double-Blind, Placebo-Controlled Study of Carboplatin Plus Etoposide With or Without Atezolizumab (Anti-PD-L1 Antibody) in Patients With Untreated Extensive-Stage Small Cell Lung Cancer

#### Organization Study ID Info
**ID:** GO30081
#### Organization
**Class:** INDUSTRY
**Full Name:** Hoffmann-La Roche
#### Secondary ID Infos
**ID:** 2015-004861-97
**Type:** EUDRACT_NUMBER
### Status Module
#### Completion Date
**Date:** 2022-07-07

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-07-28

**Type:** ACTUAL

**Last Update Submit Date:** 2023-07-10

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2018-04-24

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2019-06-13

**Type:** ACTUAL

**Results First Submit Date:** 2019-04-19

**Results First Submit QC Date:** 2019-05-21

#### Start Date
**Date:** 2016-06-07

**Type:** ACTUAL

**Status Verified Date:** 2023-07

#### Study First Post Date
**Date:** 2016-05-05
**Type:** ESTIMATED
**Study First Submit Date:** 2016-05-04
**Study First Submit QC Date:** 2016-05-04
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Hoffmann-La Roche

#### Responsible Party

**Type:** SPONSOR

### Description Module

**Brief Summary:** This randomized, Phase I/III, multicenter, double-blinded, placebo-controlled study was designed to evaluate the safety and efficacy of atezolizumab (anti-programmed death-ligand 1 \[PD-L1\] antibody) in combination with carboplatin plus (+) etoposide compared with treatment with placebo + carboplatin + etoposide in chemotherapy-naive participants with ES-SCLC. Participants will be randomized in a 1:1 ratio to receive either atezolizumab + carboplatin + etoposide or placebo + carboplatin + etoposide on 21-day cycles for four cycles in the induction phase followed by maintenance with atezolizumab or placebo until progressive disease (PD) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Treatment can be continued until persistent radiographic PD or symptomatic deterioration.

### Conditions Module

**Conditions:**

- Small Cell Lung Carcinoma

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 503

**Type:** ACTUAL

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants received intravenous infusions of atezolizumab 1200 milligrams (mg) in combination with carboplatin to achieve an initial target area under the concentration-time curve (AUC) of 5 milligrams per milliliter per minute (mg/mL/min) followed by etoposide 100 milligrams per square meter (mg/m\^2) on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) atezolizumab 1200 mg on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.

**Intervention Names:**

- Drug: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody

- Drug: Carboplatin

- Drug: Etoposide

**Label:** Atezolizumab + Carboplatin + Etoposide

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Participants received intravenous infusions of placebo in combination with carboplatin to achieve an initial target AUC of 5 mg/mL/min followed by etoposide 100 mg/m\^2 on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) placebo on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.

**Intervention Names:**

- Drug: Carboplatin

- Drug: Etoposide

- Drug: Placebo

**Label:** Placebo + Carboplatin + Etoposide

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Atezolizumab + Carboplatin + Etoposide

**Description:** Atezolizumab intravenous infusion was administered at a dose of 1200 mg on Day 1 of each 21-day cycle during the induction phase (Cycles 1-4) and maintenance phase (Cycle 5 onward).

**Name:** Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody

**Other Names:**

- MPDL3280A, RO5541267, Tecentriq

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Atezolizumab + Carboplatin + Etoposide

- Placebo + Carboplatin + Etoposide

**Description:** Carboplatin intravenous infusion to achieve an initial target AUC of 5 mg/mL/min was administered on Day 1 of each 21-day cycle during the induction phase (Cycles 1-4).

**Name:** Carboplatin

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- Atezolizumab + Carboplatin + Etoposide

- Placebo + Carboplatin + Etoposide

**Description:** Etoposide intravenous infusion was administered at a dose of 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle during the induction phase (Cycles 1-4).

**Name:** Etoposide

**Type:** DRUG

#### Intervention 4

**Arm Group Labels:**

- Placebo + Carboplatin + Etoposide

**Description:** Placebo intravenous infusion was administered on Day 1 of each 21-day cycle during the induction phase (Cycles 1-4) and maintenance phase (Cycle 5 onward).

**Name:** Placebo

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as at least 20% increase in the sum of the longest diameter of target lesions compared to baseline, or unequivocal progression in non-target lesion(s), or the appearance of new lesion(s).

**Measure:** Duration of Progression-Free Survival (PFS) as Assessed by the Investigator Using RECIST v1.1 in the Global Population

**Time Frame:** Baseline until PD or death, whichever occurs first (up to approximately 23 months)

**Description:** OS is defined as the time from randomization to death from any cause.

**Measure:** Duration of Overall Survival (OS) in the Global Population

**Time Frame:** Baseline until death from any cause (up to approximately 23 months)

#### Secondary Outcomes

**Description:** Objective response (OR) is defined as complete response (CR) or partial response (PR) as determined by the investigator according to RECIST v1.1.

**Measure:** Percentage of Participants With Objective Response Rate (ORR) as Assessed by the Investigator Using RECIST v1.1 in the Global Population

**Time Frame:** Baseline until partial response (PR) or complete response (CR), whichever occurs first (up to approximately 23 months)

**Description:** DOR is defined as the time interval from first occurrence of a documented objective response to the time of disease progression as determined by the investigator using RECIST v1.1 or death from any cause, whichever comes first.

**Measure:** Duration of Response (DOR) as Assessed by the Investigator Using RECIST v1.1 in the Global Population

**Time Frame:** First occurrence of PR or CR until PD or death, whichever occurs first (up to approximately 23 months)

**Description:** PFS rates at 6 months and at 1 year is defined as the proportion of participants who are alive without disease progression 6 months and 1 year after randomization, respectively.

**Measure:** PFS Rate at 6 Months and at 1 Year in Global Population

**Time Frame:** 6 months, 1 year

**Description:** OS rates at 1 and 2 years is defined as the proportion of participants who are alive 1 year and 2 years after randomization, respectively.

**Measure:** OS Rate at 1 Year and 2 Years in the Global Population

**Time Frame:** 1 year, 2 years

**Description:** TTD according to the EORTC QLQ-C30 and EORTC QLQ-LC13 measures were evaluated in each of the following linearly transformed symptom scores: cough, dyspnea (single item), dyspnea (multi-item subscale), chest pain, or arm/shoulder pain. The linear transformation gives each individual symptom subscale a possible score of 0 to 100. For the symptom to be considered "deteriorated," a score increase of ≥10 points above baseline must be held for at least two consecutive assessments or an initial score increase of ≥10 points is followed by death within 3 weeks from the last assessment. A ≥ 10-point change in the symptoms subscale score is perceived by participants as clinically significant.

**Measure:** Time to Deterioration (TTD) Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Core 30 (C30) and Supplemental Lung Cancer Module (QLQ-LC13) in the Global Population

**Time Frame:** Baseline until deterioration per symptom subscale (up to approximately 23 months)

**Description:** The percentage of participants with at least one adverse event in the global population.

**Measure:** Percentage of Participants With at Least One Adverse Event in the Global Population

**Time Frame:** Baseline until up to 90 days after end of treatment (up to approximately 49 months)

**Description:** The baseline prevalence and post-baseline incidence of ADAs against atezolizumab.

**Measure:** Percentage of Participants With Anti-Drug Antibodies (ADA) to Atezolizumab in the Global Population

**Time Frame:** Predose (0 hours [H]) on Day (D) 1 of Cycles (C) 1, 2, 3, 4, 8, 16, and every 8 cycles (Q8C) thereafter (cycle = 21 days) until treatment discontinuation (up to 23 months) and 120 days after last dose (up to approximately 23 months overall)

**Description:** Atezolizumab maximum observed plasma concentration (Cmax; 30 minutes following the end of the atezolizumab infusion) for each respective day.

**Measure:** Maximum Observed Serum Concentration (Cmax) of Atezolizumab in the Global Population

**Time Frame:** Post-dose Day 1 of Cycle 1 (cycle length = 21 days)

**Description:** Atezolizumab pre-dose plasma concentration (Cmin) for each respective day.

**Measure:** Minimum Observed Serum Concentration (Cmin) of Atezolizumab in the Global Population

**Time Frame:** Predose on Day 1 of Cycles 1, 3, 4, 8, 16 and 24 (cycle length = 21 days)

**Description:** Plasma concentration of carboplatin in the Global population.

**Measure:** Plasma Concentration of Carboplatin in the Global Population

**Time Frame:** Predose, before end of infusion, and after end of carboplatin infusion on Day 1 of Cycle 1 and Cycle 3 (cycle = 21 days)

**Description:** Plasma concentration of etoposide in the Global Population.

**Measure:** Plasma Concentration of Etoposide in the Global Population

**Time Frame:** Predose, before end of infusion, 1 and 4 hours after end of carboplatin infusion on Day 1 of Cycle 1 and Cycle 3 (cycle = 21 days)

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Histologically or cytologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group \[VALG\] staging system)
* No prior systemic treatment for ES-SCLC
* Eastern Cooperative Oncology Group performance status of 0 or 1
* Measurable disease, as defined by RECIST v1.1
* Adequate hematologic and end organ function
* Treatment-free for at least 6 months since last chemo/radiotherapy, among those treated (with curative intent) with prior chemo/radiotherapy for limited-stage SCLC

Exclusion Criteria:

* Active or untreated central nervous system (CNS) metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation
* Malignancies other than SCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome
* Pregnant or lactating women
* History of autoimmune disease
* History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
* Positive test result for human immunodeficiency virus (HIV)
* Active hepatitis B or hepatitis C
* Severe infections at the time of randomization
* Significant cardiovascular disease
* Prior treatment with cluster of differentiation (CD) 137 agonists or immune checkpoint blockade therapies, anti-programmed death-1 (PD-1), and anti-PD-L1 therapeutic antibody
* History of severe (or known) hypersensitivity to chimeric or humanized antibodies or fusion proteins or any component of atezolizumab formulation.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Fort Myers

**Country:** United States

**Facility:** Florida Cancer Specialists - Fort Myers (Broadway)

**State:** Florida

**Zip:** 33901

**Location 2:**

**City:** Orlando

**Country:** United States

**Facility:** Florida Hospital

**State:** Florida

**Zip:** 32804

**Location 3:**

**City:** Saint Petersburg

**Country:** United States

**Facility:** Florida Cancer Specialists.

**State:** Florida

**Zip:** 33705

**Location 4:**

**City:** Marietta

**Country:** United States

**Facility:** Northwest Georgia Oncology Centers PC - Marietta

**State:** Georgia

**Zip:** 30060

**Location 5:**

**City:** Chicago

**Country:** United States

**Facility:** Rush University Medical Center

**State:** Illinois

**Zip:** 60612-3244

**Location 6:**

**City:** Peoria

**Country:** United States

**Facility:** Illinois Cancer Care

**State:** Illinois

**Zip:** 61615

**Location 7:**

**City:** Zion

**Country:** United States

**Facility:** Cancer Treatment Centers of America - Midwestern Regional Medical Center

**State:** Illinois

**Zip:** 60099

**Location 8:**

**City:** Louisville

**Country:** United States

**Facility:** Louisville Oncology

**State:** Kentucky

**Zip:** 40202

**Location 9:**

**City:** Scarborough

**Country:** United States

**Facility:** New England Cancer Specialists

**State:** Maine

**Zip:** 04074

**Location 10:**

**City:** Baltimore

**Country:** United States

**Facility:** Weinberg CA Inst Franklin Sq

**State:** Maryland

**Zip:** 21237

**Location 11:**

**City:** Rochester

**Country:** United States

**Facility:** Mayo Clinic

**State:** Minnesota

**Zip:** 55905

**Location 12:**

**City:** Las Vegas

**Country:** United States

**Facility:** Comprehensive Cancer Centers of Nevada - Eastern Avenue

**State:** Nevada

**Zip:** 89169

**Location 13:**

**City:** Paramus

**Country:** United States

**Facility:** The Valley Hospital

**State:** New Jersey

**Zip:** 07652

**Location 14:**

**City:** Binghamton

**Country:** United States

**Facility:** Broome Oncology - Binghamton

**State:** New York

**Zip:** 13905

**Location 15:**

**City:** Charlotte

**Country:** United States

**Facility:** Levine Cancer Institute

**State:** North Carolina

**Zip:** 28204

**Location 16:**

**City:** Chattanooga

**Country:** United States

**Facility:** Tennessee Oncology Chattanooga

**State:** Tennessee

**Zip:** 37404

**Location 17:**

**City:** Nashville

**Country:** United States

**Facility:** Tennessee Oncology PLLC - Nashville (20th Ave)

**State:** Tennessee

**Zip:** 37203

**Location 18:**

**City:** Nashville

**Country:** United States

**Facility:** Vanderbilt Medical Center

**State:** Tennessee

**Zip:** 37232-7610

**Location 19:**

**City:** Fairfax

**Country:** United States

**Facility:** Virginia Cancer Specialists, PC

**State:** Virginia

**Zip:** 22031

**Location 20:**

**City:** Roanoke

**Country:** United States

**Facility:** Blue Ridge Cancer Care

**State:** Virginia

**Zip:** 24014

**Location 21:**

**City:** Tacoma

**Country:** United States

**Facility:** Northwest Medical Specialties

**State:** Washington

**Zip:** 98405

**Location 22:**

**City:** Madison

**Country:** United States

**Facility:** University of Wisconsin

**State:** Wisconsin

**Zip:** 53705

**Location 23:**

**City:** Camperdown

**Country:** Australia

**Facility:** Chris O'Brien Lifehouse

**State:** New South Wales

**Zip:** 2050

**Location 24:**

**City:** Chermside

**Country:** Australia

**Facility:** The Prince Charles Hospital; Oncology Dept.

**State:** Queensland

**Zip:** 4032

**Location 25:**

**City:** Parkville

**Country:** Australia

**Facility:** Royal Melbourne Hospital; Hematology and Medical Oncology

**State:** Victoria

**Zip:** 3052

**Location 26:**

**City:** Linz

**Country:** Austria

**Facility:** Kepler Universitätskliniken GmbH - Med Campus III; Abt. für Lungenkrankheiten

**Zip:** 4020

**Location 27:**

**City:** Salzburg

**Country:** Austria

**Facility:** Salzburger Landeskliniken; Universitätsklinik für Pneumologie/ Lungenheilkunde

**Zip:** 5020

**Location 28:**

**City:** Wien

**Country:** Austria

**Facility:** Klinik Penzing; Abteilung für Atemwegs- und Lungenkrankheiten

**Zip:** 1140

**Location 29:**

**City:** Wien

**Country:** Austria

**Facility:** Krankenhaus Nord - Klinik Floridsdorf; Abteilung Pulmologie

**Zip:** 1210

**Location 30:**

**City:** Salvador

**Country:** Brazil

**Facility:** Santa Casa de Misericordia de Salvador

**State:** BA

**Zip:** 40050-410

**Location 31:**

**City:** Lajeado

**Country:** Brazil

**Facility:** Hospital Bruno Born

**State:** RS

**Zip:** 95900-000

**Location 32:**

**City:** Porto Alegre

**Country:** Brazil

**Facility:** Hospital das Clinicas - UFRGS

**State:** RS

**Zip:** 90035-903

**Location 33:**

**City:** Sao Paulo

**Country:** Brazil

**Facility:** Instituto do Cancer do Estado de Sao Paulo - ICESP

**State:** SP

**Zip:** 01246-000

**Location 34:**

**City:** Recoleta

**Country:** Chile

**Facility:** Bradford Hill Centro de Investigaciones Clinicas

**Zip:** 8420383

**Location 35:**

**City:** Santiago

**Country:** Chile

**Facility:** OrlandiOncología

**Zip:** 7500713

**Location 36:**

**City:** Beijing

**Country:** China

**Facility:** Beijing Cancer Hospital

**Zip:** 100142

**Location 37:**

**City:** Changchun

**Country:** China

**Facility:** Jilin Cancer Hospital

**Zip:** 132013

**Location 38:**

**City:** Guangzhou

**Country:** China

**Facility:** The First Affiliated Hospital of Guangzhou Medical University

**Zip:** 510120

**Location 39:**

**City:** Harbin

**Country:** China

**Facility:** Harbin Medical University Cancer Hospital

**Zip:** 150081

**Location 40:**

**City:** Nanjing City

**Country:** China

**Facility:** Jiangsu Cancer Hospital

**Zip:** 211100

**Location 41:**

**City:** Shanghai City

**Country:** China

**Facility:** Fudan University Shanghai Cancer Center

**Zip:** 200120

**Location 42:**

**City:** Shanghai

**Country:** China

**Facility:** Zhongshan Hospital Fudan University

**Zip:** 200032

**Location 43:**

**City:** Zhejiang

**Country:** China

**Facility:** Zhejiang Cancer Hospital

**Zip:** 310022

**Location 44:**

**City:** Zhengzhou

**Country:** China

**Facility:** Henan Cancer Hospital

**Zip:** 450008

**Location 45:**

**City:** Olomouc

**Country:** Czechia

**Facility:** Fakultni nemocnice Olomouc

**Zip:** 779 00

**Location 46:**

**City:** Praha 4 - Krc

**Country:** Czechia

**Facility:** Thomayerova nemocnice

**Zip:** 140 59

**Location 47:**

**City:** Praha 8

**Country:** Czechia

**Facility:** Fakultni nemocnice Na Bulovce

**Zip:** 180 81

**Location 48:**

**City:** Bordeaux

**Country:** France

**Facility:** Institut Bergonie; Oncologie

**Zip:** 33076

**Location 49:**

**City:** Caen

**Country:** France

**Facility:** Centre Francois Baclesse; Oncologie

**Zip:** 14076

**Location 50:**

**City:** Lille

**Country:** France

**Facility:** Hopital Calmette; Pneumologie Oncologie Ouest

**Zip:** 59037

**Location 51:**

**City:** Marseille

**Country:** France

**Facility:** Hôpital Nord - AP-HM Marseille#

**Zip:** 13915

**Location 52:**

**City:** Gauting

**Country:** Germany

**Facility:** Asklepios-Fachklinik Muenchen-Gauting; Klinik Für Pneumologie

**Zip:** 82131

**Location 53:**

**City:** Großhansdorf

**Country:** Germany

**Facility:** LungenClinic Großhansdorf GmbH

**Zip:** 22927

**Location 54:**

**City:** Halle

**Country:** Germany

**Facility:** Krankenhaus Martha-Maria Halle-Doelau gGmbH; Klinik fuer Innere Medizin II

**Zip:** 06120

**Location 55:**

**City:** Heidelberg

**Country:** Germany

**Facility:** Thoraxklinik Heidelberg gGmbH

**Zip:** 69126

**Location 56:**

**City:** Immenhausen

**Country:** Germany

**Facility:** Fachklinik für Lungenerkrankungen

**Zip:** 34376

**Location 57:**

**City:** Athens

**Country:** Greece

**Facility:** Sotiria Chest Hospital of Athens

**Zip:** 11527

**Location 58:**

**City:** Athens

**Country:** Greece

**Facility:** Agioi Anargyroi; 3Rd Dept. of Medical Oncology

**Zip:** 145 64

**Location 59:**

**City:** Patras

**Country:** Greece

**Facility:** University Hospital of Patras Medical Oncology

**Zip:** 265 04

**Location 60:**

**City:** Budapest

**Country:** Hungary

**Facility:** Semmelweis Egyetem, AOK, Pulmonologiai Klinika

**Zip:** 1083

**Location 61:**

**City:** Budapest

**Country:** Hungary

**Facility:** Orszagos Koranyi TBC es Pulmonologiai Intezet

**Zip:** 1121

**Location 62:**

**City:** Debrecen

**Country:** Hungary

**Facility:** Debreceni Egyetem, Klinikai Kozpont, Tudogyogyaszati Klinika

**Zip:** 4032

**Location 63:**

**City:** Torokbalint

**Country:** Hungary

**Facility:** Tudogyogyintezet Torokbalint

**Zip:** 2045

**Location 64:**

**City:** Parma

**Country:** Italy

**Facility:** A.O. Universitaria Di Parma

**State:** Emilia-Romagna

**Zip:** 43100

**Location 65:**

**City:** Roma

**Country:** Italy

**Facility:** Policlinico Universitario Campus Biomedico; Uoc Oncologia Medica

**State:** Lazio

**Zip:** 00128

**Location 66:**

**City:** Milano

**Country:** Italy

**Facility:** Fondazione IRCCS Istituto Nazionale dei Tumori

**State:** Lombardia

**Zip:** 20133

**Location 67:**

**City:** Milano

**Country:** Italy

**Facility:** Irccs Istituto Europeo di Oncologia (IEO); Divisione di Oncologia

**State:** Lombardia

**Zip:** 20141

**Location 68:**

**City:** San Giovanni Rotondo

**Country:** Italy

**Facility:** IRCCS Ospedale Casa Sollievo Della Sofferenza; Oncologia

**State:** Puglia

**Zip:** 71013

**Location 69:**

**City:** Pisa

**Country:** Italy

**Facility:** Azienda Ospedaliera Universitaria Pisana - Ospedale Cisanello; Dipartimento Cardio Toraco Vascolare

**State:** Toscana

**Zip:** 56124

**Location 70:**

**City:** Fukuoka

**Country:** Japan

**Facility:** Kyushu University Hospital; Respiratory

**Zip:** 812-8582

**Location 71:**

**City:** Hyogo

**Country:** Japan

**Facility:** National Hospital Organization Himeji Medical Center

**Zip:** 670-8520

**Location 72:**

**City:** Kanagawa

**Country:** Japan

**Facility:** Kanagawa Cancer Center;Thoracic Oncology

**Zip:** 241-8515

**Location 73:**

**City:** Kyoto

**Country:** Japan

**Facility:** University Hospital Kyoto Prefectural University of Medicine,?Pulmonary Medicine

**Zip:** 602-8566

**Location 74:**

**City:** Miyagi

**Country:** Japan

**Facility:** Sendai Kousei Hospital; Pulmonary Medicine

**Zip:** 980-0873

**Location 75:**

**City:** Okayama

**Country:** Japan

**Facility:** Kurashiki Central Hospital; Respiratory Medicine

**Zip:** 710-8602

**Location 76:**

**City:** Osaka

**Country:** Japan

**Facility:** Kindai University Hospital; Medical Oncology

**Zip:** 589-8511

**Location 77:**

**City:** Osaka

**Country:** Japan

**Facility:** National Hospital Organization Kinki-Chuo Chest Medical Center; Internal Medicine

**Zip:** 591-8555

**Location 78:**

**City:** Satima

**Country:** Japan

**Facility:** Saitama Cancer Center; Thoracic Oncology

**Zip:** 362-0806

**Location 79:**

**City:** Shizuoka

**Country:** Japan

**Facility:** Shizuoka Cancer Center; Thoracic Oncology

**Zip:** 411-8777

**Location 80:**

**City:** Tokyo

**Country:** Japan

**Facility:** Tokyo Metropolitan Komagome Hospital; Thoracic Oncology and Respiratory Medicine

**Zip:** 113-8677

**Location 81:**

**City:** Tokyo

**Country:** Japan

**Facility:** The Cancer Institute Hospital of JFCR, Respiratory Medicine

**Zip:** 135-8550

**Location 82:**

**City:** Wakayama

**Country:** Japan

**Facility:** Wakayama Medical University Hospital; Respiratory Medicine and Medical Oncology

**Zip:** 641-8509

**Location 83:**

**City:** Seongnam-si

**Country:** Korea, Republic of

**Facility:** Seoul National University Bundang Hospital

**Zip:** 463-707

**Location 84:**

**City:** Seoul

**Country:** Korea, Republic of

**Facility:** Seoul National University Hospital

**Zip:** 03080

**Location 85:**

**City:** Seoul

**Country:** Korea, Republic of

**Facility:** Asan Medical Center

**Zip:** 05505

**Location 86:**

**City:** Seoul

**Country:** Korea, Republic of

**Facility:** Samsung Medical Center

**Zip:** 135-710

**Location 87:**

**City:** Cdmx

**Country:** Mexico

**Facility:** Health Pharma Professional Research

**State:** Mexico CITY (federal District)

**Zip:** 03100

**Location 88:**

**City:** Gdansk

**Country:** Poland

**Facility:** Medical University of Gdansk

**Zip:** 80-952

**Location 89:**

**City:** Lodz

**Country:** Poland

**Facility:** Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi

**Zip:** 93-513

**Location 90:**

**City:** Olsztyn

**Country:** Poland

**Facility:** Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc; Oddzial V Chemioterapii Nowotworow Pluc

**Zip:** 10-357

**Location 91:**

**City:** Otwock

**Country:** Poland

**Facility:** Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy

**Zip:** 05-400

**Location 92:**

**City:** Poznan

**Country:** Poland

**Facility:** Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu

**Zip:** 60-569

**Location 93:**

**City:** Warszawa

**Country:** Poland

**Facility:** Centrum Onkologii - Inst.Im. Marii Sklodowskiej-Curie; Oncology

**Zip:** 02-781

**Location 94:**

**City:** Moscovskaya Oblast

**Country:** Russian Federation

**Facility:** Moscow City Oncology Hospital #62

**State:** Moskovskaja Oblast

**Zip:** 143423

**Location 95:**

**City:** Moscow

**Country:** Russian Federation

**Facility:** N.N.Burdenko Main Military Clinical Hospital; Oncology Dept

**State:** Moskovskaja Oblast

**Zip:** 105229

**Location 96:**

**City:** Moscow

**Country:** Russian Federation

**Facility:** Russian Oncology Research Center n.a. N.N. Blokhin

**State:** Moskovskaja Oblast

**Zip:** 115478

**Location 97:**

**City:** Sankt-peterburg

**Country:** Russian Federation

**Facility:** City Clinical Onc.

**State:** Sankt Petersburg

**Zip:** 198255

**Location 98:**

**City:** St. Petersburg

**Country:** Russian Federation

**Facility:** Scientific Research Oncology Institute named after N.N. Petrov; Oncology

**State:** Sankt Petersburg

**Zip:** 197758

**Location 99:**

**City:** Novosibirsk

**Country:** Russian Federation

**Facility:** City Clinical Hospital No. 1

**Zip:** 630047

**Location 100:**

**City:** Belgrade

**Country:** Serbia

**Facility:** Clinical Center of Serbia

**Zip:** 11000

**Location 101:**

**City:** Nis

**Country:** Serbia

**Facility:** Clinical Center Nis; Clinic for pulmonary diseases

**Zip:** 18 000

**Location 102:**

**City:** Sant Andreu de La Barca

**Country:** Spain

**Facility:** Hospital Univ Vall d'Hebron; Servicio de Oncologia

**State:** Barcelona

**Zip:** 08740

**Location 103:**

**City:** Madrid

**Country:** Spain

**Facility:** Hospital Ramon y Cajal; Servicio de Oncologia

**Zip:** 28034

**Location 104:**

**City:** Madrid

**Country:** Spain

**Facility:** Hospital Universitario La Paz; Servicio de Oncologia

**Zip:** 28046

**Location 105:**

**City:** Malaga

**Country:** Spain

**Facility:** Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia

**Zip:** 29010

**Location 106:**

**City:** Sevilla

**Country:** Spain

**Facility:** Hospital Universitario Virgen del Rocio; Servicio de Oncologia

**Zip:** 41013

**Location 107:**

**City:** Zaragoza

**Country:** Spain

**Facility:** Hosp Clinico Univ Lozano Blesa; División De Oncología Médica

**Zip:** 50009

**Location 108:**

**City:** Taipei

**Country:** Taiwan

**Facility:** National Taiwan Uni Hospital; Internal Medicine

**Zip:** 100

**Location 109:**

**City:** Taipei

**Country:** Taiwan

**Facility:** Taipei Veterans General Hospital; Chest Dept , Section of Thoracic Oncology

**Zip:** 112

**Location 110:**

**City:** Taoyuan

**Country:** Taiwan

**Facility:** Chang Gung Medical Foundation - Linkou; Chest Dept

**Zip:** 333

**Location 111:**

**City:** Exeter

**Country:** United Kingdom

**Facility:** Royal Devon & Exeter Hospital; Oncology Centre

**Zip:** EX2 5DW

**Location 112:**

**City:** London

**Country:** United Kingdom

**Facility:** Barts and the London NHS Trust.

**Zip:** EC1A 7BE

**Location 113:**

**City:** London

**Country:** United Kingdom

**Facility:** Guys and St Thomas NHS Foundation Trust, Guys Hospital

**Zip:** SE1 9RT

**Location 114:**

**City:** Manchester

**Country:** United Kingdom

**Facility:** Christie Hospital Nhs Trust; Medical Oncology

**Zip:** M2O 4BX

#### Overall Officials

**Official 1:**

**Affiliation:** Hoffmann-La Roche

**Name:** Clinical Trials

**Role:** STUDY_DIRECTOR

### References Module

#### References

**Citation:** Liu SV, Reck M, Mansfield AS, Mok T, Scherpereel A, Reinmuth N, Garassino MC, De Castro Carpeno J, Califano R, Nishio M, Orlandi F, Alatorre-Alexander J, Leal T, Cheng Y, Lee JS, Lam S, McCleland M, Deng Y, Phan S, Horn L. Updated Overall Survival and PD-L1 Subgroup Analysis of Patients With Extensive-Stage Small-Cell Lung Cancer Treated With Atezolizumab, Carboplatin, and Etoposide (IMpower133). J Clin Oncol. 2021 Feb 20;39(6):619-630. doi: 10.1200/JCO.20.01055. Epub 2021 Jan 13.

**PMID:** 33439693

**Citation:** Mansfield AS, Kazarnowicz A, Karaseva N, Sanchez A, De Boer R, Andric Z, Reck M, Atagi S, Lee JS, Garassino M, Liu SV, Horn L, Wen X, Quach C, Yu W, Kabbinavar F, Lam S, Morris S, Califano R. Safety and patient-reported outcomes of atezolizumab, carboplatin, and etoposide in extensive-stage small-cell lung cancer (IMpower133): a randomized phase I/III trial. Ann Oncol. 2020 Feb;31(2):310-317. doi: 10.1016/j.annonc.2019.10.021. Epub 2019 Dec 9.

**PMID:** 31959349

**Citation:** Nishio M, Sugawara S, Atagi S, Akamatsu H, Sakai H, Okamoto I, Takayama K, Hayashi H, Nakagawa Y, Kawakami T. Subgroup Analysis of Japanese Patients in a Phase III Study of Atezolizumab in Extensive-stage Small-cell Lung Cancer (IMpower133). Clin Lung Cancer. 2019 Nov;20(6):469-476.e1. doi: 10.1016/j.cllc.2019.07.005. Epub 2019 Jul 31.

**PMID:** 31466854

**Citation:** Horn L, Mansfield AS, Szczesna A, Havel L, Krzakowski M, Hochmair MJ, Huemer F, Losonczy G, Johnson ML, Nishio M, Reck M, Mok T, Lam S, Shames DS, Liu J, Ding B, Lopez-Chavez A, Kabbinavar F, Lin W, Sandler A, Liu SV; IMpower133 Study Group. First-Line Atezolizumab plus Chemotherapy in Extensive-Stage Small-Cell Lung Cancer. N Engl J Med. 2018 Dec 6;379(23):2220-2229. doi: 10.1056/NEJMoa1809064. Epub 2018 Sep 25.

**PMID:** 30280641

## Document Section

### Large Document Module

#### Large Docs

- Date: 2019-03-06

- Filename: Prot_SAP_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: True

- Label: Study Protocol and Statistical Analysis Plan

- Size: 4423710

- Type Abbrev: Prot_SAP

- Upload Date: 2019-05-21T12:32

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000002283

- Term: Carcinoma, Bronchogenic

- ID: D000001984

- Term: Bronchial Neoplasms

- ID: D000008175

- Term: Lung Neoplasms

- ID: D000012142

- Term: Respiratory Tract Neoplasms

- ID: D000013899

- Term: Thoracic Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000008171

- Term: Lung Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: All

- Name: All Conditions

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M5534

- Name: Carcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M11172

- Name: Lung Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M28323

- Name: Small Cell Lung Carcinoma

- Relevance: HIGH

- As Found: Small Cell Lung Carcinoma

- ID: M5540

- Name: Carcinoma, Bronchogenic

- Relevance: LOW

- As Found: Unknown

- ID: M5260

- Name: Bronchial Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M14979

- Name: Respiratory Tract Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M16658

- Name: Thoracic Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T5271

- Name: Small Cell Lung Cancer

- Relevance: HIGH

- As Found: Small Cell Lung Cancer

### Condition Browse Module - Meshes

- ID: D000055752

- Term: Small Cell Lung Carcinoma

### Intervention Browse Module - Ancestors

- ID: D000007155

- Term: Immunologic Factors

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000000972

- Term: Antineoplastic Agents, Phytogenic

- ID: D000059005

- Term: Topoisomerase II Inhibitors

- ID: D000059003

- Term: Topoisomerase Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000082082

- Term: Immune Checkpoint Inhibitors

- ID: D000074322

- Term: Antineoplastic Agents, Immunological

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: ANeo

- Name: Antineoplastic Agents

### Intervention Browse Module - Browse Leaves

- ID: M4225

- Name: Antibodies

- Relevance: HIGH

- As Found: Program

- ID: M18650

- Name: Carboplatin

- Relevance: HIGH

- As Found: System

- ID: M8191

- Name: Etoposide

- Relevance: HIGH

- As Found: Tolerability

- ID: M349417

- Name: Atezolizumab

- Relevance: HIGH

- As Found: Pemetrexed

- ID: M341643

- Name: Etoposide phosphate

- Relevance: LOW

- As Found: Unknown

- ID: M10184

- Name: Immunoglobulins

- Relevance: LOW

- As Found: Unknown

- ID: M4230

- Name: Antibodies, Monoclonal

- Relevance: HIGH

- As Found: Pemetrexed

- ID: M10201

- Name: Immunologic Factors

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M2342

- Name: Immune Checkpoint Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M1346

- Name: Antineoplastic Agents, Immunological

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000016190

- Term: Carboplatin

- ID: D000005047

- Term: Etoposide

- ID: C000594389

- Term: Atezolizumab

- ID: D000000906

- Term: Antibodies

- ID: D000000911

- Term: Antibodies, Monoclonal

### Misc Info Module

#### Removed Countries

- Country: Czech Republic

- Country: Hong Kong

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

**Description:** All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.

#### Event Groups

**Group ID:** EG000

**Title:** Placebo + Carboplatin + Etoposide - Global

**Deaths Num Affected:** 11

**Deaths Num At Risk:** 196

**Description:** Participants in the Global population received intravenous infusions of placebo in combination with carboplatin to achieve an initial target AUC of 5 mg/mL/min followed by etoposide 100 mg/m\^2 on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) placebo on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.

**ID:** EG000

**Other Num Affected:** 187

**Other Num at Risk:** 196

**Serious Number Affected:** 69

**Serious Number At Risk:** 196

**Title:** Placebo + Carboplatin + Etoposide - Global

**Group ID:** EG001

**Title:** Atezolizumab + Carboplatin + Etoposide - Global

**Deaths Num Affected:** 5

**Deaths Num At Risk:** 198

**Description:** Participants in the Global population received intravenous infusions of atezolizumab 1200 milligrams (mg) in combination with carboplatin to achieve an initial target area under the concentration-time curve (AUC) of 5 milligrams per milliliter per minute (mg/mL/min) followed by etoposide 100 milligrams per square meter (mg/m\^2) on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) atezolizumab 1200 mg on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.

**ID:** EG001

**Other Num Affected:** 191

**Other Num at Risk:** 198

**Serious Number Affected:** 81

**Serious Number At Risk:** 198

**Title:** Atezolizumab + Carboplatin + Etoposide - Global

**Group ID:** EG002

**Title:** Placebo + Carboplatin + Etoposide - China

**Deaths Num Affected:** 1

**Deaths Num At Risk:** 52

**Description:** Participants in the China population received intravenous infusions of placebo in combination with carboplatin to achieve an initial target AUC of 5 mg/mL/min followed by etoposide 100 mg/m\^2 on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) placebo on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.

**ID:** EG002

**Other Num Affected:** 52

**Other Num at Risk:** 52

**Serious Number Affected:** 14

**Serious Number At Risk:** 52

**Title:** Placebo + Carboplatin + Etoposide - China

**Group ID:** EG003

**Title:** Atezolizumab + Carboplatin + Etoposide - China

**Deaths Num Affected:** 3

**Deaths Num At Risk:** 57

**Description:** Participants in the China population received intravenous infusions of atezolizumab 1200 milligrams (mg) in combination with carboplatin to achieve an initial target area under the concentration-time curve (AUC) of 5 milligrams per milliliter per minute (mg/mL/min) followed by etoposide 100 milligrams per square meter (mg/m\^2) on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) atezolizumab 1200 mg on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.

**ID:** EG003

**Other Num Affected:** 56

**Other Num at Risk:** 57

**Serious Number Affected:** 22

**Serious Number At Risk:** 57

**Title:** Atezolizumab + Carboplatin + Etoposide - China

**Frequency Threshold:** 5

#### Other Events

**Term:** Anaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA version 25.0

**Term:** Leukopenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA version 25.0

**Term:** Neutropenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA version 25.0

**Term:** Thrombocytopenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA version 25.0

**Term:** Sinus tachycardia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA version 25.0

**Term:** Hyperthyroidism

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Endocrine disorders

**Source Vocabulary:** MedDRA version 25.0

**Term:** Hypothyroidism

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Endocrine disorders

**Source Vocabulary:** MedDRA version 25.0

**Term:** Abdominal distension

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA version 25.0

**Term:** Abdominal pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA version 25.0

**Term:** Constipation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA version 25.0

**Term:** Diarrhoea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA version 25.0

**Term:** Nausea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA version 25.0

**Term:** Stomatitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA version 25.0

**Term:** Vomiting

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA version 25.0

**Term:** Asthenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA version 25.0

**Term:** Chest discomfort

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA version 25.0

**Term:** Chest pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA version 25.0

**Term:** Fatigue

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA version 25.0

**Term:** Oedema peripheral

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA version 25.0

**Term:** Pyrexia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA version 25.0

**Term:** Hepatic function abnormal

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA version 25.0

**Term:** Nasopharyngitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA version 25.0

**Term:** Upper respiratory tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA version 25.0

**Term:** Urinary tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA version 25.0

**Term:** Infusion related reaction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA version 25.0

**Term:** Alanine aminotransferase increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA version 25.0

**Term:** Aspartate aminotransferase increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA version 25.0

**Term:** Blood alkaline phosphatase increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA version 25.0

**Term:** Blood bilirubin increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA version 25.0

**Term:** Blood cholesterol increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA version 25.0

**Term:** Blood creatinine increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA version 25.0

**Term:** Blood glucose increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA version 25.0

**Term:** Blood triglycerides increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA version 25.0

**Term:** Electrocardiogram QT prolonged

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA version 25.0

**Term:** Gamma-glutamyltransferase increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA version 25.0

**Term:** Haemoglobin decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA version 25.0

**Term:** Neutrophil count decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA version 25.0

**Term:** Platelet count decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA version 25.0

**Term:** Protein urine present

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA version 25.0

**Term:** Weight decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA version 25.0

**Term:** Weight increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA version 25.0

**Term:** White blood cell count decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA version 25.0

**Term:** Decreased appetite

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA version 25.0

**Term:** Diabetes mellitus

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA version 25.0

**Term:** Hyperglycaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA version 25.0

**Term:** Hypertriglyceridaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA version 25.0

**Term:** Hypoalbuminaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA version 25.0

**Term:** Hypochloraemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA version 25.0

**Term:** Hypokalaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA version 25.0

**Term:** Hypomagnesaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA version 25.0

**Term:** Hyponatraemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA version 25.0

**Term:** Hypoproteinaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA version 25.0

**Term:** Arthralgia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA version 25.0

**Term:** Back pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA version 25.0

**Term:** Pain in extremity

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA version 25.0

**Term:** Dizziness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA version 25.0

**Term:** Headache

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA version 25.0

**Term:** Insomnia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA version 25.0

**Term:** Proteinuria

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA version 25.0

**Term:** Cough

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA version 25.0

**Term:** Dyspnoea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA version 25.0

**Term:** Haemoptysis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA version 25.0

**Term:** Oropharyngeal pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA version 25.0

**Term:** Productive cough

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA version 25.0

**Term:** Alopecia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA version 25.0

**Term:** Pruritus

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA version 25.0

**Term:** Rash

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA version 25.0

**Term:** Rash maculo-papular

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA version 25.0

**Term:** Hypertension

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA version 25.0

#### Serious Events

**Term:** Anaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 196

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 198

**Num Events:** 4

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 52

**Num Events:** 1

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Disseminated intravascular coagulation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 196

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 198

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Febrile neutropenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num Affected:** 9

**Num At Risk:** 196

**Num Events:** 9

**Group ID:** EG001

**Num Affected:** 5

**Num At Risk:** 198

**Num Events:** 5

**Group ID:** EG002

**Num Affected:** 2

**Num At Risk:** 52

**Num Events:** 2

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 57

**Num Events:** 1

**Term:** Granulocytopenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 196

**Group ID:** EG001

**Num At Risk:** 198

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 52

**Num Events:** 1

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Leukocytosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 196

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 198

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Leukopenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 196

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 198

**Num Events:** 2

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Myelosuppression

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 196

**Group ID:** EG001

**Num At Risk:** 198

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 52

**Num Events:** 1

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 57

**Num Events:** 1

**Term:** Neutropenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num Affected:** 8

**Num At Risk:** 196

**Num Events:** 8

**Group ID:** EG001

**Num Affected:** 7

**Num At Risk:** 198

**Num Events:** 7

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 52

**Num Events:** 1

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 57

**Num Events:** 1

**Term:** Pancytopenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num Affected:** 4

**Num At Risk:** 196

**Num Events:** 4

**Group ID:** EG001

**Num At Risk:** 198

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Thrombocytopenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num Affected:** 4

**Num At Risk:** 196

**Num Events:** 4

**Group ID:** EG001

**Num Affected:** 5

**Num At Risk:** 198

**Num Events:** 5

**Group ID:** EG002

**Num Affected:** 2

**Num At Risk:** 52

**Num Events:** 2

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Atrial fibrillation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 196

**Num Events:** 4

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 198

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Atrioventricular block complete

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 196

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 198

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Cardiac failure

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 196

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 198

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Cardiac tamponade

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 196

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 198

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Cardiopulmonary failure

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 196

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 198

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Coronary artery disease

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 196

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 198

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Palpitations

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 196

**Group ID:** EG001

**Num At Risk:** 198

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 52

**Num Events:** 1

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Pericardial effusion

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 196

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 198

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Supraventricular tachycardia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 196

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 198

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Autoimmune thyroiditis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Endocrine disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 196

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 198

**Num Events:** 2

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Inappropriate antidiuretic hormone secretion

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Endocrine disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 196

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 198

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Abdominal adhesions

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 196

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 198

**Num Events:** 2

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Abdominal pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 196

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 198

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Autoimmune colitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 196

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 198

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Colitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 196

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 198

**Num Events:** 2

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Diarrhoea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 196

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 198

**Num Events:** 3

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Diverticular perforation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 196

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 198

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Faeces discoloured

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 196

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 198

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Gastric ulcer perforation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 196

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 198

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Gastritis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 196

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 198

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Gastrointestinal haemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 196

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 198

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Ileus

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 196

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 198

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Intestinal obstruction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 196

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 198

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 57

**Num Events:** 1

**Term:** Lip oedema

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 196

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 198

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Nausea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 196

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 198

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Pancreatitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 196

**Num Events:** 3

**Group ID:** EG001

**Num At Risk:** 198

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Pancreatitis acute

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 196

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 198

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Proctitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 196

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 198

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Small intestinal obstruction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 196

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 198

**Num Events:** 2

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Vomiting

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 196

**Num Events:** 3

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 198

**Num Events:** 3

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Asthenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 196

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 198

**Num Events:** 2

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Chest discomfort

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 196

**Group ID:** EG001

**Num At Risk:** 198

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 57

**Num Events:** 1

**Term:** Chest pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 196

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 198

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Death

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 196

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 198

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num Affected:** 2

**Num At Risk:** 57

**Num Events:** 2

**Term:** Fatigue

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 196

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 198

**Num Events:** 3

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** General physical health deterioration

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 196

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 198

**Num Events:** 2

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Influenza like illness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 196

**Group ID:** EG001

**Num At Risk:** 198

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 57

**Num Events:** 1

**Term:** Non-cardiac chest pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 196

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 198

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 196

**Group ID:** EG001

**Num At Risk:** 198

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 57

**Num Events:** 1

**Term:** Pyrexia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 196

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 198

**Num Events:** 2

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 52

**Num Events:** 1

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Systemic inflammatory response syndrome

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 196

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 198

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Cholangitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 196

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 198

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Drug-induced liver injury

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 196

**Group ID:** EG001

**Num At Risk:** 198

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 57

**Num Events:** 1

**Term:** Jaundice

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 196

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 198

**Num Events:** 2

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Bronchitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 196

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 198

**Num Events:** 2

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Clostridium difficile colitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 196

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 198

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Clostridium difficile infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 196

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 198

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Cytomegalovirus infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 196

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 198

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Device related sepsis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 196

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 198

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Lower respiratory tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 196

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 198

**Num Events:** 2

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Lung abscess

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 196

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 198

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Myelitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 196

**Group ID:** EG001

**Num At Risk:** 198

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 57

**Num Events:** 1

**Term:** Neutropenic sepsis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 196

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 198

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Pneumonia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num Affected:** 10

**Num At Risk:** 196

**Num Events:** 11

**Group ID:** EG001

**Num Affected:** 12

**Num At Risk:** 198

**Num Events:** 15

**Group ID:** EG002

**Num Affected:** 4

**Num At Risk:** 52

**Num Events:** 5

**Group ID:** EG003

**Num Affected:** 4

**Num At Risk:** 57

**Num Events:** 7

**Term:** Pulmonary sepsis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 196

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 198

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Pyopneumothorax

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 196

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 198

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Respiratory tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 196

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 198

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Sepsis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 196

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 198

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Septic shock

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 196

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 198

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Upper respiratory tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 196

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 198

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 57

**Num Events:** 1

**Term:** Urinary tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 196

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 198

**Num Events:** 2

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Femur fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 196

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 198

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Head injury

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 196

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 198

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Infusion related reaction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 196

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 198

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Limb injury

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 196

**Group ID:** EG001

**Num At Risk:** 198

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 57

**Num Events:** 1

**Term:** Radiation oesophagitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 196

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 198

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Thoracic vertebral fracture

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 196

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 198

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Alanine aminotransferase increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 196

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 198

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Aspartate aminotransferase increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 196

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 198

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Blood alkaline phosphatase increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 196

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 198

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Blood bilirubin increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 196

**Group ID:** EG001

**Num At Risk:** 198

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 57

**Num Events:** 1

**Term:** Blood creatinine increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 196

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 198

**Num Events:** 2

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** C-reactive protein increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 196

**Group ID:** EG001

**Num At Risk:** 198

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 57

**Num Events:** 1

**Term:** Liver function test increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 196

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 198

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Neutrophil count decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 196

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 198

**Group ID:** EG002

**Num Affected:** 2

**Num At Risk:** 52

**Num Events:** 2

**Group ID:** EG003

**Num Affected:** 2

**Num At Risk:** 57

**Num Events:** 2

**Term:** Platelet count decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 196

**Num Events:** 2

**Group ID:** EG001

**Num At Risk:** 198

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 52

**Num Events:** 1

**Group ID:** EG003

**Num Affected:** 4

**Num At Risk:** 57

**Num Events:** 4

**Term:** Transaminases increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 196

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 198

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** White blood cell count decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 196

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 198

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 57

**Num Events:** 1

**Term:** Decreased appetite

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 196

**Group ID:** EG001

**Num At Risk:** 198

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 52

**Num Events:** 1

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Dehydration

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 196

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 198

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Electrolyte imbalance

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 196

**Group ID:** EG001

**Num At Risk:** 198

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 57

**Num Events:** 1

**Term:** Hyperglycaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 196

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 198

**Num Events:** 2

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Hypokalaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 196

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 198

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Hypomagnesaemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 196

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 198

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Hyponatraemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num Affected:** 4

**Num At Risk:** 196

**Num Events:** 4

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 198

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Arthralgia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 196

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 198

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Muscular weakness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 196

**Group ID:** EG001

**Num At Risk:** 198

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 57

**Num Events:** 1

**Term:** Myalgia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 196

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 198

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Pain in extremity

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 196

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 198

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Metastatic neoplasm

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 196

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 198

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Paraneoplastic syndrome

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 196

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 198

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Plasma cell myeloma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 196

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 198

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Tumour pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 196

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 198

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Cerebral infarction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 196

**Group ID:** EG001

**Num At Risk:** 198

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 52

**Num Events:** 1

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Cerebrovascular accident

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 196

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 198

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Dysarthria

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 196

**Group ID:** EG001

**Num At Risk:** 198

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 57

**Num Events:** 1

**Term:** Guillain-Barre syndrome

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 196

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 198

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Neuropathy peripheral

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 196

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 198

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Somnolence

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 196

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 198

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Spinal cord oedema

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 196

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 198

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Syncope

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 196

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 198

**Num Events:** 3

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Transient ischaemic attack

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 196

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 198

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Trigeminal neuralgia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 196

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 198

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Alcohol abuse

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 196

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 198

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Depression

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 196

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 198

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Acute kidney injury

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 196

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 198

**Num Events:** 2

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Tubulointerstitial nephritis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 196

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 198

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Acute respiratory failure

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 196

**Num Events:** 2

**Group ID:** EG001

**Num At Risk:** 198

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Asthma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 196

**Group ID:** EG001

**Num At Risk:** 198

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 57

**Num Events:** 1

**Term:** Bronchial obstruction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 196

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 198

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Chronic obstructive pulmonary disease

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 196

**Num Events:** 3

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 198

**Num Events:** 2

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Dyspnoea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 196

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 198

**Num Events:** 1

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 52

**Num Events:** 1

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Haemoptysis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 196

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 198

**Num Events:** 2

**Group ID:** EG002

**Num Affected:** 1

**Num At Risk:** 52

**Num Events:** 1

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Hypercapnia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 196

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 198

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Pleural effusion

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 196

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 198

**Num Events:** 2

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Pneumonitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 196

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 198

**Num Events:** 4

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num Affected:** 2

**Num At Risk:** 57

**Num Events:** 2

**Term:** Pneumothorax

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 196

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 198

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Pulmonary embolism

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 196

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 198

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Pulmonary oedema

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 196

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 198

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Respiratory failure

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 196

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 198

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Rash

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 196

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 198

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num Affected:** 1

**Num At Risk:** 57

**Num Events:** 1

**Term:** Skin toxicity

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 196

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 198

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Peripheral arterial occlusive disease

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 196

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 198

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Peripheral artery occlusion

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 196

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 198

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Superior vena cava syndrome

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 196

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 198

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Term:** Venous thrombosis limb

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA version 25.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 196

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 198

**Num Events:** 1

**Group ID:** EG002

**Num At Risk:** 52

**Group ID:** EG003

**Num At Risk:** 57

**Time Frame:** From the first study drug administration to the data cutoff date: 7 July 2022 (up to 49 months).

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 251

**Group ID:** BG001

**Value:** 252

**Group ID:** BG002

**Value:** 503

**Units:** Participants

### Group

**ID:** BG000

**Title:** Placebo + Carboplatin + Etoposide - All

**Description:** All participants in the Global or China population received intravenous infusions of placebo in combination with carboplatin to achieve an initial target AUC of 5 mg/mL/min followed by etoposide 100 mg/m\^2 on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) placebo on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.

### Group

**ID:** BG001

**Title:** Atezolizumab + Carboplatin + Etoposide - All

**Description:** All participants in the Global or China population received intravenous infusions of atezolizumab 1200 milligrams (mg) in combination with carboplatin to achieve an initial target area under the concentration-time curve (AUC) of 5 milligrams per milliliter per minute (mg/mL/min) followed by etoposide 100 milligrams per square meter (mg/m\^2) on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) atezolizumab 1200 mg on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 9.0

**Value:** 63.6

#### Measurement

**Group ID:** BG001

**Spread:** 8.8

**Value:** 63.8

#### Measurement

**Group ID:** BG002

**Spread:** 8.9

**Value:** 63.7

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 202

**Group ID:** BG001

**Value:** 201

**Group ID:** BG002

**Value:** 403

**Class Title:** Global

#### Measurement

**Group ID:** BG000

**Spread:** 8.8

**Value:** 60.7

#### Measurement

**Group ID:** BG001

**Spread:** 9.0

**Value:** 59.7

#### Measurement

**Group ID:** BG002

**Spread:** 8.9

**Value:** 60.2

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 53

**Group ID:** BG001

**Value:** 57

**Group ID:** BG002

**Value:** 110

**Class Title:** China

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 70

#### Measurement

**Group ID:** BG001

**Value:** 72

#### Measurement

**Group ID:** BG002

**Value:** 142

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 132

#### Measurement

**Group ID:** BG001

**Value:** 129

#### Measurement

**Group ID:** BG002

**Value:** 261

**Category Title:** Male

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 202

**Group ID:** BG001

**Value:** 201

**Group ID:** BG002

**Value:** 403

**Class Title:** Global

#### Measurement

**Group ID:** BG000

**Value:** 12

#### Measurement

**Group ID:** BG001

**Value:** 11

#### Measurement

**Group ID:** BG002

**Value:** 23

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 41

#### Measurement

**Group ID:** BG001

**Value:** 46

#### Measurement

**Group ID:** BG002

**Value:** 87

**Category Title:** Male

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 53

**Group ID:** BG001

**Value:** 57

**Group ID:** BG002

**Value:** 110

**Class Title:** China

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 8

#### Measurement

**Group ID:** BG001

**Value:** 8

#### Measurement

**Group ID:** BG002

**Value:** 16

**Category Title:** Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 185

#### Measurement

**Group ID:** BG001

**Value:** 187

#### Measurement

**Group ID:** BG002

**Value:** 372

**Category Title:** Not Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 9

#### Measurement

**Group ID:** BG001

**Value:** 6

#### Measurement

**Group ID:** BG002

**Value:** 15

**Category Title:** Unknown or Not Reported

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 202

**Group ID:** BG001

**Value:** 201

**Group ID:** BG002

**Value:** 403

**Class Title:** Global

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 53

#### Measurement

**Group ID:** BG001

**Value:** 57

#### Measurement

**Group ID:** BG002

**Value:** 110

**Category Title:** Not Hispanic or Latino

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Unknown or Not Reported

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 53

**Group ID:** BG001

**Value:** 57

**Group ID:** BG002

**Value:** 110

**Class Title:** China

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 1

**Category Title:** American Indian or Alaska Native

#### Measurement

**Group ID:** BG000

**Value:** 36

#### Measurement

**Group ID:** BG001

**Value:** 33

#### Measurement

**Group ID:** BG002

**Value:** 69

**Category Title:** Asian

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Native Hawaiian or Other Pacific Islander

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 3

**Category Title:** Black or African American

#### Measurement

**Group ID:** BG000

**Value:** 159

#### Measurement

**Group ID:** BG001

**Value:** 163

#### Measurement

**Group ID:** BG002

**Value:** 322

**Category Title:** White

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** More than one race

#### Measurement

**Group ID:** BG000

**Value:** 4

#### Measurement

**Group ID:** BG001

**Value:** 4

#### Measurement

**Group ID:** BG002

**Value:** 8

**Category Title:** Unknown or Not Reported

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 202

**Group ID:** BG001

**Value:** 201

**Group ID:** BG002

**Value:** 403

**Class Title:** Global

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** American Indian or Alaska Native

#### Measurement

**Group ID:** BG000

**Value:** 53

#### Measurement

**Group ID:** BG001

**Value:** 57

#### Measurement

**Group ID:** BG002

**Value:** 110

**Category Title:** Asian

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Native Hawaiian or Other Pacific Islander

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Black or African American

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** White

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** More than one race

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Unknown or Not Reported

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 53

**Group ID:** BG001

**Value:** 57

**Group ID:** BG002

**Value:** 110

**Class Title:** China

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Population Description:** The intent-to-treat (ITT) population included 503 participants (All) with 403 in the Global population. An additional 100 participants enrolled in the China Extension. The China population included 10 Chinese participants from the Global population plus 100 participants from the China Extension.
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Description:** As reported from Electronic Case Report Form (eCRF).
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** The Global population included 403 participants. The China population included 100 participants enrolled during the China Extension plus 10 Chinese participants from the Global population.
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** The intent-to-treat (ITT) population included 503 participants (All) with 403 in the Global population. An additional 100 participants enrolled in the China Extension. The China population included 10 Chinese participants from the Global population plus 100 participants from the China Extension.
**Title:** Ethnicity (NIH/OMB)
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** The intent-to-treat (ITT) population included 503 participants (All) with 403 in the Global population. An additional 100 participants enrolled in the China Extension. The China population included 10 Chinese participants from the Global population plus 100 participants from the China Extension.
**Title:** Race (NIH/OMB)
**Unit of Measure:** Participants
**Population Description:** The intent-to-treat (ITT) population included 503 participants (All) with 403 in the Global population. An additional 100 participants enrolled in the China Extension. The China population included 10 Chinese participants from the Global population plus 100 participants from the China Extension. Separate analyses were performed for the Global population and the China population in the study.
## Results Section - More Information Module
### Certain Agreement
**Other Details:** 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.
**Restriction Type:** OTHER
**Restrictive Agreement:** True
### Point of Contact
**Email:** genentech@druginfo.com
**Organization:** Hoffmann-La Roche
**Phone:** 800-821-8590
**Title:** Medical Communications
## Results Section - Outcome Measures Module
### Outcome Measure 1
#### Analysis
**CI Lower Limit:** 0.62
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.96
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.0170
**P-Value Comment:** 
**Parameter Type:** Stratified Hazard Ratio
**Parameter Value:** 0.77
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** 
### Outcome Measure 2
#### Analysis
**CI Lower Limit:** 0.54
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.91
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.0069
**P-Value Comment:** 
**Parameter Type:** Stratified Hazard Ratio
**Parameter Value:** 0.70
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** 
### Outcome Measure 3
#### Analysis
**CI Lower Limit:** 0.55
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.37
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 
**P-Value Comment:** 
**Parameter Type:** Odds Ratio (OR)
**Parameter Value:** 0.87
**Statistical Comment:** 
**Statistical Method:** 
**Tested Non-Inferiority:** 
### Outcome Measure 4
#### Analysis
**CI Lower Limit:** 0.562
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 0.911
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.0063
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.715
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** 
### Outcome Measure 5
#### Analysis
**CI Lower Limit:** -0.33
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 17.27
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** PFS Rate at 6 months
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.0593
**P-Value Comment:** 
**Parameter Type:** Difference in Event Free Rate
**Parameter Value:** 8.47
**Statistical Comment:** 
**Statistical Method:** Z-test
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 1.52
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 13.02
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** PFS Rate at 1 year
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.0133
**P-Value Comment:** 
**Parameter Type:** Difference in Event Free Rate
**Parameter Value:** 7.27
**Statistical Comment:** 
**Statistical Method:** Z-test
**Tested Non-Inferiority:** 
### Outcome Measure 6
#### Analysis
**CI Lower Limit:** 3.29
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 23.64
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** OS Rate at 1 year
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.0095
**P-Value Comment:** 
**Parameter Type:** Difference in Event Free Rate
**Parameter Value:** 13.46
**Statistical Comment:** 
**Statistical Method:** Z-test
**Tested Non-Inferiority:** 
### Outcome Measure 7
#### Analysis
**CI Lower Limit:** 0.795
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.874
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Cough
**Non-Inferiority Comment:** Stratified analysis. Stratification factors: Sex (male vs female) and ECOG (0 vs 1).
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.3604
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 1.221
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 0.722
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.553
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Pain in Chest
**Non-Inferiority Comment:** Stratified analysis. Stratification factors: Sex (male vs female) and ECOG (0 vs 1).
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.7712
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 1.058
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 0.747
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.552
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Pain in Arm or Shoulder
**Non-Inferiority Comment:** Stratified analysis. Stratification factors: Sex (male vs female) and ECOG (0 vs 1).
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.6922
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 1.077
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 0.549
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.019
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Dyspnea
**Non-Inferiority Comment:** Stratified analysis. Stratification factors: Sex (male vs female) and ECOG (0 vs 1).
**Non-Inferiority Type:** SUPERIORITY
**Other Analysis Description:** 
**P-Value:** 0.0650
**P-Value Comment:** 
**Parameter Type:** Hazard Ratio (HR)
**Parameter Value:** 0.748
**Statistical Comment:** 
**Statistical Method:** Log Rank
**Tested Non-Inferiority:** 
### Outcome Measure 8
### Outcome Measure 9
### Outcome Measure 10
### Outcome Measure 11
### Outcome Measure 12
### Outcome Measure 13
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 4.2
- **Spread:** 4.2
- **Upper Limit:** 4.5
- **Value:** 4.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 4.4
- **Spread:** 4.4
- **Upper Limit:** 5.6
- **Value:** 5.2
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 9.3
- **Spread:** 9.3
- **Upper Limit:** 11.3
- **Value:** 10.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 10.8
- **Spread:** 10.8
- **Upper Limit:** 15.9
- **Value:** 12.3
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 70.29
- **Spread:** 
- **Upper Limit:** 82.38
- **Value:** 76.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 67.50
- **Spread:** 
- **Upper Limit:** 80.03
- **Value:** 74.1
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 2.9
- **Spread:** 
- **Upper Limit:** 3.9
- **Value:** 3.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 3.5
- **Spread:** 
- **Upper Limit:** 4.2
- **Value:** 4.1
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 16.56
- **Spread:** 
- **Upper Limit:** 28.22
- **Value:** 22.39
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 24.26
- **Spread:** 
- **Upper Limit:** 37.45
- **Value:** 30.86
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 2.14
- **Spread:** 
- **Upper Limit:** 8.56
- **Value:** 5.35
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 7.85
- **Spread:** 
- **Upper Limit:** 17.40
- **Value:** 12.62
**Title:** 
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 38.23
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 51.69
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** Insufficient number of participants with events.
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** NA
- **Comment:** Insufficient number of participants with events.
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** NA
**Title:** 
#### Outcome Measure 7
**Class:**
##### Category
**Measurements:**
- **Comment:** Insufficient number of participants with events.
- **Group ID:** OG000
- **Lower Limit:** 16.6
- **Spread:** 
- **Upper Limit:** NA
- **Value:** NA
- **Comment:** Insufficient number of participants with events.
- **Group ID:** OG001
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** 20.3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** Insufficient number of participants with events.
- **Group ID:** OG000
- **Lower Limit:** 10.9
- **Spread:** 
- **Upper Limit:** NA
- **Value:** NA
- **Comment:** Insufficient number of participants with events.
- **Group ID:** OG001
- **Lower Limit:** NA
- **Spread:** 
- **Upper Limit:** NA
- **Value:** NA
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** Insufficient number of participants with events.
- **Group ID:** OG000
- **Lower Limit:** 8.8
- **Spread:** 
- **Upper Limit:** NA
- **Value:** NA
- **Comment:** Insufficient number of participants with events.
- **Group ID:** OG001
- **Lower Limit:** 9.2
- **Spread:** 
- **Upper Limit:** NA
- **Value:** NA
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 3.6
- **Spread:** 
- **Upper Limit:** 8.8
- **Value:** 5.6
- **Comment:** Insufficient number of participants with events.
- **Group ID:** OG001
- **Lower Limit:** 5.5
- **Spread:** 
- **Upper Limit:** NA
- **Value:** NA
**Title:** 
#### Outcome Measure 8
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 96.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 100.0
**Title:** 
#### Outcome Measure 9
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2.0
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 196
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 18.6
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 188
**Units:** Participants
#### Outcome Measure 10
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 135
- **Upper Limit:** 
- **Value:** 389
**Title:** 
#### Outcome Measure 11
**Class:**
##### Category
**Measurements:**
- **Comment:** Below the level of detection.
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** NA
- **Upper Limit:** 
- **Value:** NA
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 194
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 32.1
- **Upper Limit:** 
- **Value:** 80.6
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 174
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 56.4
- **Upper Limit:** 
- **Value:** 138
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 156
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 73.5
- **Upper Limit:** 
- **Value:** 186
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 88
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 63.1
- **Upper Limit:** 
- **Value:** 196
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 22
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 43.4
- **Upper Limit:** 
- **Value:** 221
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 4
**Units:** Participants
#### Outcome Measure 12
**Class:**
##### Category
**Measurements:**
- **Comment:** Below level of detection.
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** NA
- **Upper Limit:** 
- **Value:** NA
- **Comment:** Below level of detection.
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** NA
- **Upper Limit:** 
- **Value:** NA
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 12
- **Group ID:** OG001
- **Value:** 11
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 4880
- **Upper Limit:** 
- **Value:** 13300
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 5060
- **Upper Limit:** 
- **Value:** 11200
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 12
- **Group ID:** OG001
- **Value:** 11
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1880
- **Upper Limit:** 
- **Value:** 7200
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1670
- **Upper Limit:** 
- **Value:** 6860
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 11
- **Group ID:** OG001
- **Value:** 12
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 58.3
- **Upper Limit:** 
- **Value:** 144
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 48.1
- **Upper Limit:** 
- **Value:** 126
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 12
- **Group ID:** OG001
- **Value:** 13
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 3590
- **Upper Limit:** 
- **Value:** 13900
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 5090
- **Upper Limit:** 
- **Value:** 11300
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 13
- **Group ID:** OG001
- **Value:** 13
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1630
- **Upper Limit:** 
- **Value:** 7180
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2200
- **Upper Limit:** 
- **Value:** 6540
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 13
- **Group ID:** OG001
- **Value:** 13
**Units:** Participants
#### Outcome Measure 13
**Class:**
##### Category
**Measurements:**
- **Comment:** Below level of detection.
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** NA
- **Upper Limit:** 
- **Value:** NA
- **Comment:** Below level of detection.
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** NA
- **Upper Limit:** 
- **Value:** NA
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 12
- **Group ID:** OG001
- **Value:** 13
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 3640
- **Upper Limit:** 
- **Value:** 17000
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2860
- **Upper Limit:** 
- **Value:** 19400
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 10
- **Group ID:** OG001
- **Value:** 10
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2010
- **Upper Limit:** 
- **Value:** 11100
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1960
- **Upper Limit:** 
- **Value:** 12600
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 8
- **Group ID:** OG001
- **Value:** 12
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2360
- **Upper Limit:** 
- **Value:** 7640
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 1230
- **Upper Limit:** 
- **Value:** 7300
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 9
- **Group ID:** OG001
- **Value:** 9
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** Below level of detection.
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** NA
- **Upper Limit:** 
- **Value:** NA
- **Comment:** Below level of detection.
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** NA
- **Upper Limit:** 
- **Value:** NA
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 13
- **Group ID:** OG001
- **Value:** 13
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2180
- **Upper Limit:** 
- **Value:** 16600
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 3600
- **Upper Limit:** 
- **Value:** 17700
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 11
- **Group ID:** OG001
- **Value:** 9
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 3740
- **Upper Limit:** 
- **Value:** 12400
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2810
- **Upper Limit:** 
- **Value:** 12200
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 10
- **Group ID:** OG001
- **Value:** 13
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1230
- **Upper Limit:** 
- **Value:** 6740
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2090
- **Upper Limit:** 
- **Value:** 7960
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 10
- **Group ID:** OG001
- **Value:** 11
**Units:** Participants
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as at least 20% increase in the sum of the longest diameter of target lesions compared to baseline, or unequivocal progression in non-target lesion(s), or the appearance of new lesion(s).
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Population Description:** The ITT population was defined as all randomized participants, regardless of whether the participant received the assigned treatment.
**Reporting Status:** POSTED
**Time Frame:** Baseline until PD or death, whichever occurs first (up to approximately 23 months)
**Title:** Duration of Progression-Free Survival (PFS) as Assessed by the Investigator Using RECIST v1.1 in the Global Population
**Type:** PRIMARY
**Unit of Measure:** Months
##### Group
**Description:** Participants received intravenous infusions of placebo in combination with carboplatin to achieve an initial target AUC of 5 mg/mL/min followed by etoposide 100 mg/m\^2 on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) placebo on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
**ID:** OG000
**Title:** Placebo + Carboplatin + Etoposide
##### Group
**Description:** Participants received intravenous infusions of atezolizumab 1200 milligrams (mg) in combination with carboplatin to achieve an initial target area under the concentration-time curve (AUC) of 5 milligrams per milliliter per minute (mg/mL/min) followed by etoposide 100 milligrams per square meter (mg/m\^2) on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) atezolizumab 1200 mg on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
**ID:** OG001
**Title:** Atezolizumab + Carboplatin + Etoposide
#### Outcome Measure 2
**Description:** OS is defined as the time from randomization to death from any cause.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Population Description:** The ITT population was defined as all randomized participants, regardless of whether the participant received the assigned treatment.
**Reporting Status:** POSTED
**Time Frame:** Baseline until death from any cause (up to approximately 23 months)
**Title:** Duration of Overall Survival (OS) in the Global Population
**Type:** PRIMARY
**Unit of Measure:** Months
##### Group
**Description:** Participants received intravenous infusions of placebo in combination with carboplatin to achieve an initial target AUC of 5 mg/mL/min followed by etoposide 100 mg/m\^2 on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) placebo on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
**ID:** OG000
**Title:** Placebo + Carboplatin + Etoposide
##### Group
**Description:** Participants received intravenous infusions of atezolizumab 1200 milligrams (mg) in combination with carboplatin to achieve an initial target area under the concentration-time curve (AUC) of 5 milligrams per milliliter per minute (mg/mL/min) followed by etoposide 100 milligrams per square meter (mg/m\^2) on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) atezolizumab 1200 mg on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
**ID:** OG001
**Title:** Atezolizumab + Carboplatin + Etoposide
#### Outcome Measure 3
**Description:** Objective response (OR) is defined as complete response (CR) or partial response (PR) as determined by the investigator according to RECIST v1.1.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** The ITT population was defined as all randomized participants, regardless of whether the participant received the assigned treatment.
**Reporting Status:** POSTED
**Time Frame:** Baseline until partial response (PR) or complete response (CR), whichever occurs first (up to approximately 23 months)
**Title:** Percentage of Participants With Objective Response Rate (ORR) as Assessed by the Investigator Using RECIST v1.1 in the Global Population
**Type:** SECONDARY
**Unit of Measure:** Percentage of participants
##### Group
**Description:** Participants received intravenous infusions of placebo in combination with carboplatin to achieve an initial target AUC of 5 mg/mL/min followed by etoposide 100 mg/m\^2 on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) placebo on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
**ID:** OG000
**Title:** Placebo + Carboplatin + Etoposide
##### Group
**Description:** Participants received intravenous infusions of atezolizumab 1200 milligrams (mg) in combination with carboplatin to achieve an initial target area under the concentration-time curve (AUC) of 5 milligrams per milliliter per minute (mg/mL/min) followed by etoposide 100 milligrams per square meter (mg/m\^2) on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) atezolizumab 1200 mg on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
**ID:** OG001
**Title:** Atezolizumab + Carboplatin + Etoposide
#### Outcome Measure 4
**Description:** DOR is defined as the time interval from first occurrence of a documented objective response to the time of disease progression as determined by the investigator using RECIST v1.1 or death from any cause, whichever comes first.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Population Description:** The ITT population was defined as all randomized participants, regardless of whether the participant received the assigned treatment.
**Reporting Status:** POSTED
**Time Frame:** First occurrence of PR or CR until PD or death, whichever occurs first (up to approximately 23 months)
**Title:** Duration of Response (DOR) as Assessed by the Investigator Using RECIST v1.1 in the Global Population
**Type:** SECONDARY
**Unit of Measure:** Months
##### Group
**Description:** Participants received intravenous infusions of placebo in combination with carboplatin to achieve an initial target AUC of 5 mg/mL/min followed by etoposide 100 mg/m\^2 on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) placebo on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
**ID:** OG000
**Title:** Placebo + Carboplatin + Etoposide
##### Group
**Description:** Participants received intravenous infusions of atezolizumab 1200 milligrams (mg) in combination with carboplatin to achieve an initial target area under the concentration-time curve (AUC) of 5 milligrams per milliliter per minute (mg/mL/min) followed by etoposide 100 milligrams per square meter (mg/m\^2) on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) atezolizumab 1200 mg on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
**ID:** OG001
**Title:** Atezolizumab + Carboplatin + Etoposide
#### Outcome Measure 5
**Description:** PFS rates at 6 months and at 1 year is defined as the proportion of participants who are alive without disease progression 6 months and 1 year after randomization, respectively.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** NUMBER
**Population Description:** The ITT population was defined as all randomized participants, regardless of whether the participant received the assigned treatment.
**Reporting Status:** POSTED
**Time Frame:** 6 months, 1 year
**Title:** PFS Rate at 6 Months and at 1 Year in Global Population
**Type:** SECONDARY
**Unit of Measure:** Percentage of participants
##### Group
**Description:** Participants received intravenous infusions of placebo in combination with carboplatin to achieve an initial target AUC of 5 mg/mL/min followed by etoposide 100 mg/m\^2 on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) placebo on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
**ID:** OG000
**Title:** Placebo + Carboplatin + Etoposide
##### Group
**Description:** Participants received intravenous infusions of atezolizumab 1200 milligrams (mg) in combination with carboplatin to achieve an initial target area under the concentration-time curve (AUC) of 5 milligrams per milliliter per minute (mg/mL/min) followed by etoposide 100 milligrams per square meter (mg/m\^2) on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) atezolizumab 1200 mg on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
**ID:** OG001
**Title:** Atezolizumab + Carboplatin + Etoposide
#### Outcome Measure 6
**Description:** OS rates at 1 and 2 years is defined as the proportion of participants who are alive 1 year and 2 years after randomization, respectively.
**Parameter Type:** NUMBER
**Population Description:** The ITT population was defined as all randomized participants, regardless of whether the participant received the assigned treatment.
**Reporting Status:** POSTED
**Time Frame:** 1 year, 2 years
**Title:** OS Rate at 1 Year and 2 Years in the Global Population
**Type:** SECONDARY
**Unit of Measure:** Percentage of participants
##### Group
**Description:** Participants received intravenous infusions of placebo in combination with carboplatin to achieve an initial target AUC of 5 mg/mL/min followed by etoposide 100 mg/m\^2 on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) placebo on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
**ID:** OG000
**Title:** Placebo + Carboplatin + Etoposide
##### Group
**Description:** Participants received intravenous infusions of atezolizumab 1200 milligrams (mg) in combination with carboplatin to achieve an initial target area under the concentration-time curve (AUC) of 5 milligrams per milliliter per minute (mg/mL/min) followed by etoposide 100 milligrams per square meter (mg/m\^2) on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) atezolizumab 1200 mg on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
**ID:** OG001
**Title:** Atezolizumab + Carboplatin + Etoposide
#### Outcome Measure 7
**Description:** TTD according to the EORTC QLQ-C30 and EORTC QLQ-LC13 measures were evaluated in each of the following linearly transformed symptom scores: cough, dyspnea (single item), dyspnea (multi-item subscale), chest pain, or arm/shoulder pain. The linear transformation gives each individual symptom subscale a possible score of 0 to 100. For the symptom to be considered "deteriorated," a score increase of ≥10 points above baseline must be held for at least two consecutive assessments or an initial score increase of ≥10 points is followed by death within 3 weeks from the last assessment. A ≥ 10-point change in the symptoms subscale score is perceived by participants as clinically significant.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Population Description:** The ITT population was defined as all randomized participants, regardless of whether the participant received the assigned treatment.
**Reporting Status:** POSTED
**Time Frame:** Baseline until deterioration per symptom subscale (up to approximately 23 months)
**Title:** Time to Deterioration (TTD) Per European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Core 30 (C30) and Supplemental Lung Cancer Module (QLQ-LC13) in the Global Population
**Type:** SECONDARY
**Unit of Measure:** Month
##### Group
**Description:** Participants received intravenous infusions of placebo in combination with carboplatin to achieve an initial target AUC of 5 mg/mL/min followed by etoposide 100 mg/m\^2 on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) placebo on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
**ID:** OG000
**Title:** Placebo + Carboplatin + Etoposide
##### Group
**Description:** Participants received intravenous infusions of atezolizumab 1200 milligrams (mg) in combination with carboplatin to achieve an initial target area under the concentration-time curve (AUC) of 5 milligrams per milliliter per minute (mg/mL/min) followed by etoposide 100 milligrams per square meter (mg/m\^2) on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) atezolizumab 1200 mg on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
**ID:** OG001
**Title:** Atezolizumab + Carboplatin + Etoposide
#### Outcome Measure 8
**Description:** The percentage of participants with at least one adverse event in the global population.
**Parameter Type:** NUMBER
**Population Description:** The safety population included all treated participants, defined as participants who received any amount of any component of study treatment. For the safety analyses, patrticipants who received any amount of atezolizumab were analyzed as part of the Atezo + CE arm, even if atezolizumab was given in error.
**Reporting Status:** POSTED
**Time Frame:** Baseline until up to 90 days after end of treatment (up to approximately 49 months)
**Title:** Percentage of Participants With at Least One Adverse Event in the Global Population
**Type:** SECONDARY
**Unit of Measure:** Percentage of participants
##### Group
**Description:** Participants received intravenous infusions of placebo in combination with carboplatin to achieve an initial target AUC of 5 mg/mL/min followed by etoposide 100 mg/m\^2 on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) placebo on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
**ID:** OG000
**Title:** Placebo + Carboplatin + Etoposide
##### Group
**Description:** Participants received intravenous infusions of atezolizumab 1200 milligrams (mg) in combination with carboplatin to achieve an initial target area under the concentration-time curve (AUC) of 5 milligrams per milliliter per minute (mg/mL/min) followed by etoposide 100 milligrams per square meter (mg/m\^2) on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) atezolizumab 1200 mg on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
**ID:** OG001
**Title:** Atezolizumab + Carboplatin + Etoposide
#### Outcome Measure 9
**Description:** The baseline prevalence and post-baseline incidence of ADAs against atezolizumab.
**Parameter Type:** NUMBER
**Population Description:** ADA analyses were based on ADA observations from participants who had received atezolizumab treatment and were evaluated for immunogenicity.
**Reporting Status:** POSTED
**Time Frame:** Predose (0 hours [H]) on Day (D) 1 of Cycles (C) 1, 2, 3, 4, 8, 16, and every 8 cycles (Q8C) thereafter (cycle = 21 days) until treatment discontinuation (up to 23 months) and 120 days after last dose (up to approximately 23 months overall)
**Title:** Percentage of Participants With Anti-Drug Antibodies (ADA) to Atezolizumab in the Global Population
**Type:** SECONDARY
**Unit of Measure:** Percentage of participants
##### Group
**Description:** Participants received intravenous infusions of atezolizumab 1200 milligrams (mg) in combination with carboplatin to achieve an initial target area under the concentration-time curve (AUC) of 5 milligrams per milliliter per minute (mg/mL/min) followed by etoposide 100 milligrams per square meter (mg/m\^2) on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) atezolizumab 1200 mg on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
**ID:** OG000
**Title:** Atezolizumab + Carboplatin + Etoposide
#### Outcome Measure 10
**Description:** Atezolizumab maximum observed plasma concentration (Cmax; 30 minutes following the end of the atezolizumab infusion) for each respective day.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** PK analyses were based on PK observations from all participants who had received atezolizumab, carboplatin, or etoposide treatment and who provided at least one evaluable atezolizumab PK sample.
**Reporting Status:** POSTED
**Time Frame:** Post-dose Day 1 of Cycle 1 (cycle length = 21 days)
**Title:** Maximum Observed Serum Concentration (Cmax) of Atezolizumab in the Global Population
**Type:** SECONDARY
**Unit of Measure:** μg/mL
##### Group
**Description:** Participants received intravenous infusions of atezolizumab 1200 milligrams (mg) in combination with carboplatin to achieve an initial target area under the concentration-time curve (AUC) of 5 milligrams per milliliter per minute (mg/mL/min) followed by etoposide 100 milligrams per square meter (mg/m\^2) on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) atezolizumab 1200 mg on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
**ID:** OG000
**Title:** Atezolizumab + Carboplatin + Etoposide
#### Outcome Measure 11
**Description:** Atezolizumab pre-dose plasma concentration (Cmin) for each respective day.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** PK analyses were based on PK observations from all participants who had received atezolizumab, carboplatin, or etoposide treatment and who provided at least one evaluable atezolizumab PK sample.
**Reporting Status:** POSTED
**Time Frame:** Predose on Day 1 of Cycles 1, 3, 4, 8, 16 and 24 (cycle length = 21 days)
**Title:** Minimum Observed Serum Concentration (Cmin) of Atezolizumab in the Global Population
**Type:** SECONDARY
**Unit of Measure:** μg/mL
##### Group
**Description:** Participants received intravenous infusions of atezolizumab 1200 milligrams (mg) in combination with carboplatin to achieve an initial target area under the concentration-time curve (AUC) of 5 milligrams per milliliter per minute (mg/mL/min) followed by etoposide 100 milligrams per square meter (mg/m\^2) on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) atezolizumab 1200 mg on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
**ID:** OG000
**Title:** Atezolizumab + Carboplatin + Etoposide
#### Outcome Measure 12
**Description:** Plasma concentration of carboplatin in the Global population.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** PK analyses were based on PK observations from all participants who had received atezolizumab, carboplatin, or etoposide treatment and who provided at least one evaluable atezolizumab PK sample.
**Reporting Status:** POSTED
**Time Frame:** Predose, before end of infusion, and after end of carboplatin infusion on Day 1 of Cycle 1 and Cycle 3 (cycle = 21 days)
**Title:** Plasma Concentration of Carboplatin in the Global Population
**Type:** SECONDARY
**Unit of Measure:** ng/mL
##### Group
**Description:** Participants received intravenous infusions of placebo in combination with carboplatin to achieve an initial target AUC of 5 mg/mL/min followed by etoposide 100 mg/m\^2 on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) placebo on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
**ID:** OG000
**Title:** Placebo + Carboplatin + Etoposide
##### Group
**Description:** Participants received intravenous infusions of atezolizumab 1200 milligrams (mg) in combination with carboplatin to achieve an initial target area under the concentration-time curve (AUC) of 5 milligrams per milliliter per minute (mg/mL/min) followed by etoposide 100 milligrams per square meter (mg/m\^2) on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) atezolizumab 1200 mg on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
**ID:** OG001
**Title:** Atezolizumab + Carboplatin + Etoposide
#### Outcome Measure 13
**Description:** Plasma concentration of etoposide in the Global Population.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** PK analyses were based on PK observations from all participants who had received atezolizumab, carboplatin, or etoposide treatment and who provided at least one evaluable atezolizumab PK sample.
**Reporting Status:** POSTED
**Time Frame:** Predose, before end of infusion, 1 and 4 hours after end of carboplatin infusion on Day 1 of Cycle 1 and Cycle 3 (cycle = 21 days)
**Title:** Plasma Concentration of Etoposide in the Global Population
**Type:** SECONDARY
**Unit of Measure:** ng/mL
##### Group
**Description:** Participants received intravenous infusions of placebo in combination with carboplatin to achieve an initial target AUC of 5 mg/mL/min followed by etoposide 100 mg/m\^2 on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) placebo on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
**ID:** OG000
**Title:** Placebo + Carboplatin + Etoposide
##### Group
**Description:** Participants received intravenous infusions of atezolizumab 1200 milligrams (mg) in combination with carboplatin to achieve an initial target area under the concentration-time curve (AUC) of 5 milligrams per milliliter per minute (mg/mL/min) followed by etoposide 100 milligrams per square meter (mg/m\^2) on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) atezolizumab 1200 mg on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
**ID:** OG001
**Title:** Atezolizumab + Carboplatin + Etoposide
### Participant Flow Module
#### Group
**Description:** Participants in the Global population received intravenous infusions of placebo in combination with carboplatin to achieve an initial target AUC of 5 mg/mL/min followed by etoposide 100 mg/m\^2 on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) placebo on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
**ID:** FG000
**Title:** Placebo + Carboplatin + Etoposide - Global
#### Group
**Description:** Participants in the Global population received intravenous infusions of atezolizumab 1200 milligrams (mg) in combination with carboplatin to achieve an initial target area under the concentration-time curve (AUC) of 5 milligrams per milliliter per minute (mg/mL/min) followed by etoposide 100 milligrams per square meter (mg/m\^2) on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) atezolizumab 1200 mg on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
**ID:** FG001
**Title:** Atezolizumab + Carboplatin + Etoposide - Global
#### Group
**Description:** Participants in the China population received intravenous infusions of placebo in combination with carboplatin to achieve an initial target AUC of 5 mg/mL/min followed by etoposide 100 mg/m\^2 on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) placebo on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
**ID:** FG002
**Title:** Placebo + Carboplatin + Etoposide - China
#### Group
**Description:** Participants in the China population received intravenous infusions of atezolizumab 1200 milligrams (mg) in combination with carboplatin to achieve an initial target area under the concentration-time curve (AUC) of 5 milligrams per milliliter per minute (mg/mL/min) followed by etoposide 100 milligrams per square meter (mg/m\^2) on Day 1 of every 21-day cycle during the induction phase (Cycles 1-4). On Days 2 and 3 of every 21-day cycle during the induction phase (Cycles 1-4), etoposide 100 mg/m\^2 was administered alone. Thereafter, participants received maintenance (Cycle 5 onward) atezolizumab 1200 mg on Day 1 of every 21-day cycle until persistent radiographic PD, symptomatic deterioration, intolerable toxicity, withdrawal of consent, death, or study termination by the Sponsor.
**ID:** FG003
**Title:** Atezolizumab + Carboplatin + Etoposide - China
#### Period
**Title:** Global Period
##### Withdraw
**Type:** Death
###### Reason
**Group ID:** FG000
**Number of Subjects:** 167
###### Reason
**Group ID:** FG001
**Number of Subjects:** 151
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
###### Reason
**Group ID:** FG003
**Number of Subjects:** 0
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
###### Reason
**Group ID:** FG001
**Number of Subjects:** 4
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
###### Reason
**Group ID:** FG003
**Number of Subjects:** 0
##### Withdraw
**Type:** Physician Decision
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 2
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
###### Reason
**Group ID:** FG003
**Number of Subjects:** 0
##### Withdraw
**Type:** Study Terminated By Sponsor
###### Reason
**Group ID:** FG000
**Number of Subjects:** 21
###### Reason
**Group ID:** FG001
**Number of Subjects:** 26
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
###### Reason
**Group ID:** FG003
**Number of Subjects:** 0
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 12
###### Reason
**Group ID:** FG001
**Number of Subjects:** 18
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
###### Reason
**Group ID:** FG003
**Number of Subjects:** 0
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 202
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 201
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 0
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 0
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 202
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 201
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 0
#### Period
**Title:** China Period
##### Withdraw
**Type:** Death
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 46
###### Reason
**Group ID:** FG003
**Number of Subjects:** 48
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 1
###### Reason
**Group ID:** FG003
**Number of Subjects:** 1
##### Withdraw
**Type:** Physician Decision
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
###### Reason
**Group ID:** FG003
**Number of Subjects:** 1
##### Withdraw
**Type:** Study Terminated By Sponsor
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 3
###### Reason
**Group ID:** FG003
**Number of Subjects:** 4
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 3
###### Reason
**Group ID:** FG003
**Number of Subjects:** 3
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 53
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 57
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 0
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 53
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 57
**Pre-Assignment Details:** The total study population included 503 participants. The Global population included 403 participants. An additional 100 participants enrolled during the China Extension. The total China population included 10 Chinese participants from the Global population plus 100 participants from the China extension. 10 participants were part of the Global as well as China populations. Separate analyses were performed for the Global population and the China population in the study.
**Recruitment Details:** Participants were enrolled at 114 centers in 21 countries: United States of America, Poland, Japan, Russia, Spain, Austria, Hungary, Czech Republic, South Korea, Italy, Serbia, Australia, Greece, United Kingdom, Germany, Taiwan, France, Chile, Brazil, Mexico, and China.
**Has Results:** True