Ignite Creation Date:
2025-12-24 @ 11:20 PM
Ignite Modification Date:
2026-01-01 @ 1:13 AM
Study NCT ID:
NCT04665856
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-29
First Post:
2020-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Atezolizumab Plus Carboplatin and Etoposide With or Without Tiragolumab in Participants With Untreated Extensive-Stage Small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D055752', 'term': 'Small Cell Lung Carcinoma'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000730814', 'term': 'Tiragolumab'}, {'id': 'C000594389', 'term': 'atezolizumab'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D005047', 'term': 'Etoposide'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011034', 'term': 'Podophyllotoxin'}, {'id': 'D013764', 'term': 'Tetrahydronaphthalenes'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'genentech@druginfo.com', 'phone': '800 821-8590', 'title': 'Medical Communications', 'organization': 'Hoffmann-La Roche'}, 'certainAgreement': {'otherDetails': "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.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 32.3 months', 'description': 'Safety population included all participants who received at least one dose of the study drug. One participant from the tiragolumab arm did not receive tiragolumab and hence was included in the placebo arm group for safety analysis. AEs collected up to the primary completion date are reported here. Adverse events section will be updated one year after the study completion date.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo + Atezolizumab + Carboplatin + Etoposide', 'description': 'Participants received atezolizumab, 1200 mg, followed by tiragolumab matching placebo, and carboplatin, at a dose targeting initial target AUC of 5 mg/mL/min as an IV infusion, Q3W, on Day 1 of each 21-day cycle along with etoposide, 100 mg/m\\^2, as an IV infusion on Days 1, 2 and 3 of each 21-day cycle for 4 cycles as induction treatment. (1 Cycle = 21 days). Participants then received maintenance treatment with atezolizumab, 1200 mg, followed by tiragolumab matching placebo given as an IV infusion, Q3W, from Day 1 of Cycle 5 until disease progression, loss of clinical benefit, unacceptable toxicity, or symptomatic deterioration attributed to disease progression.', 'otherNumAtRisk': 63, 'deathsNumAtRisk': 63, 'otherNumAffected': 60, 'seriousNumAtRisk': 63, 'deathsNumAffected': 40, 'seriousNumAffected': 23}, {'id': 'EG001', 'title': 'Tiragolumab + Atezolizumab + Carboplatin + Etoposide', 'description': 'Participants received atezolizumab, 1200 mg, tiragolumab, 600 mg, and carboplatin, at a dose targeting initial target AUC of 5 mg/mL/min as an IV infusion, Q3W, on Day 1 along with etoposide, 100 mg/m\\^2, as an IV infusion on Days 1, 2 and 3 of each 21-day cycle for 4 cycles as induction treatment. (1 Cycle = 21 days). Participants then received maintenance treatment with atezolizumab, 1200 mg, followed by tiragolumab, 600 mg, given as an IV infusion, Q3W, from Day 1 of Cycle 5 until disease progression, loss of clinical benefit, unacceptable toxicity, or symptomatic deterioration attributed to disease progression.', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 60, 'seriousNumAtRisk': 60, 'deathsNumAffected': 43, 'seriousNumAffected': 21}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 100, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 122, 'numAffected': 58}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 25, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 29, 'numAffected': 10}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 21, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 30, 'numAffected': 13}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 10, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 15, 'numAffected': 9}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 7, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Supraventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 24, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 19, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 17, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 23, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 13, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 15, 'numAffected': 10}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 30, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 37, 'numAffected': 19}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 25, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 31, 'numAffected': 14}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Bilirubin conjugated increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 11, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 12, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 9, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 8, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Blood lactate dehydrogenase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 13, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 16, 'numAffected': 12}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Blood thyroid stimulating hormone increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Blood uric acid increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Electrocardiogram QT prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 9, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 13, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 13, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 12, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 37, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 101, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 144, 'numAffected': 44}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 99, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 134, 'numAffected': 39}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 105, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 144, 'numAffected': 42}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 16, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 15, 'numAffected': 13}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 13, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Hypertriglyceridaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Hyperuricaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 14, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 15, 'numAffected': 11}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 26, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 31, 'numAffected': 13}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 12, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Hypochloraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 9, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 27, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 20, 'numAffected': 15}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 10, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Hypoproteinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 14, 'numAffected': 12}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 21, 'numAffected': 21}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 14, 'numAffected': 10}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 25, 'numAffected': 17}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}], 'seriousEvents': [{'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Myelosuppression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Goitre', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Intestinal polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Infective exacerbation of bronchiectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Skull fractured base', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Subdural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Type 2 diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Myositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Subarachnoid haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Immune-mediated lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Obstructive airways disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Respiratory tract haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Dermatitis exfoliative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Pelvic venous thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}, {'term': 'Vena cava thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Investigator-Assessed Progression-Free Survival (PFS) in the Primary Analysis Set (PAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Atezolizumab + Carboplatin + Etoposide', 'description': 'Participants received atezolizumab, 1200 mg, followed by tiragolumab matching placebo, and carboplatin, at a dose targeting initial target AUC of 5 mg/mL/min as an IV infusion, Q3W, on Day 1 of each 21-day cycle along with etoposide, 100 mg/m\\^2, as an IV infusion on Days 1, 2 and 3 of each 21-day cycle for 4 cycles as induction treatment. (1 Cycle = 21 days). Participants then received maintenance treatment with atezolizumab, 1200 mg, followed by tiragolumab matching placebo given as an IV infusion, Q3W, from Day 1 of Cycle 5 until disease progression, loss of clinical benefit, unacceptable toxicity, or symptomatic deterioration attributed to disease progression.'}, {'id': 'OG001', 'title': 'Tiragolumab + Atezolizumab + Carboplatin + Etoposide', 'description': 'Participants received atezolizumab, 1200 mg, tiragolumab, 600 mg, and carboplatin, at a dose targeting initial target AUC of 5 mg/mL/min as an IV infusion, Q3W, on Day 1 along with etoposide, 100 mg/m\\^2, as an IV infusion on Days 1, 2 and 3 of each 21-day cycle for 4 cycles as induction treatment. (1 Cycle = 21 days). Participants then received maintenance treatment with atezolizumab, 1200 mg, followed by tiragolumab, 600 mg, given as an IV infusion, Q3W, from Day 1 of Cycle 5 until disease progression, loss of clinical benefit, unacceptable toxicity, or symptomatic deterioration attributed to disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.39', 'groupId': 'OG000', 'lowerLimit': '4.30', 'upperLimit': '6.77'}, {'value': '5.59', 'groupId': 'OG001', 'lowerLimit': '4.53', 'upperLimit': '7.89'}]}]}], 'analyses': [{'pValue': '0.0348', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.65', 'ciLowerLimit': '0.43', 'ciUpperLimit': '0.97', 'pValueComment': 'This study is a bridging study without formal testing, the p value here is descriptive.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 32.3 months', 'description': 'PFS was defined as time from randomization to the first occurrence of disease progression (PD), as assessed by the investigator using Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1), or death from any cause, whichever occurs first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters at prior timepoints (including baseline), in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm).', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary Analysis Set (PAS) included all randomized participants without presence or history of brain metastases at baseline.'}, {'type': 'PRIMARY', 'title': 'Overall Survival (OS) in the PAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Atezolizumab + Carboplatin + Etoposide', 'description': 'Participants received atezolizumab, 1200 mg, followed by tiragolumab matching placebo, and carboplatin, at a dose targeting initial target AUC of 5 mg/mL/min as an IV infusion, Q3W, on Day 1 of each 21-day cycle along with etoposide, 100 mg/m\\^2, as an IV infusion on Days 1, 2 and 3 of each 21-day cycle for 4 cycles as induction treatment. (1 Cycle = 21 days). Participants then received maintenance treatment with atezolizumab, 1200 mg, followed by tiragolumab matching placebo given as an IV infusion, Q3W, from Day 1 of Cycle 5 until disease progression, loss of clinical benefit, unacceptable toxicity, or symptomatic deterioration attributed to disease progression.'}, {'id': 'OG001', 'title': 'Tiragolumab + Atezolizumab + Carboplatin + Etoposide', 'description': 'Participants received atezolizumab, 1200 mg, tiragolumab, 600 mg, and carboplatin, at a dose targeting initial target AUC of 5 mg/mL/min as an IV infusion, Q3W, on Day 1 along with etoposide, 100 mg/m\\^2, as an IV infusion on Days 1, 2 and 3 of each 21-day cycle for 4 cycles as induction treatment. (1 Cycle = 21 days). Participants then received maintenance treatment with atezolizumab, 1200 mg, followed by tiragolumab, 600 mg, given as an IV infusion, Q3W, from Day 1 of Cycle 5 until disease progression, loss of clinical benefit, unacceptable toxicity, or symptomatic deterioration attributed to disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.54', 'groupId': 'OG000', 'lowerLimit': '10.35', 'upperLimit': '22.44'}, {'value': '18.69', 'groupId': 'OG001', 'lowerLimit': '14.26', 'upperLimit': '20.86'}]}]}], 'analyses': [{'pValue': '0.6105', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.89', 'ciLowerLimit': '0.56', 'ciUpperLimit': '1.40', 'pValueComment': 'This study is a bridging study without formal testing, the p value here is descriptive.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 32.3 months', 'description': 'OS was defined as the time from the date of randomization to the date of death from any cause.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'PAS included all randomized participants without presence or history of brain metastases at baseline.'}, {'type': 'SECONDARY', 'title': 'PFS in the FAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Atezolizumab + Carboplatin + Etoposide', 'description': 'Participants received atezolizumab, 1200 mg, followed by tiragolumab matching placebo, and carboplatin, at a dose targeting initial target AUC of 5 mg/mL/min as an IV infusion, Q3W, on Day 1 of each 21-day cycle along with etoposide, 100 mg/m\\^2, as an IV infusion on Days 1, 2 and 3 of each 21-day cycle for 4 cycles as induction treatment. (1 Cycle = 21 days). Participants then received maintenance treatment with atezolizumab, 1200 mg, followed by tiragolumab matching placebo given as an IV infusion, Q3W, from Day 1 of Cycle 5 until disease progression, loss of clinical benefit, unacceptable toxicity, or symptomatic deterioration attributed to disease progression.'}, {'id': 'OG001', 'title': 'Tiragolumab + Atezolizumab + Carboplatin + Etoposide', 'description': 'Participants received atezolizumab, 1200 mg, tiragolumab, 600 mg, and carboplatin, at a dose targeting initial target AUC of 5 mg/mL/min as an IV infusion, Q3W, on Day 1 along with etoposide, 100 mg/m\\^2, as an IV infusion on Days 1, 2 and 3 of each 21-day cycle for 4 cycles as induction treatment. (1 Cycle = 21 days). Participants then received maintenance treatment with atezolizumab, 1200 mg, followed by tiragolumab, 600 mg, given as an IV infusion, Q3W, from Day 1 of Cycle 5 until disease progression, loss of clinical benefit, unacceptable toxicity, or symptomatic deterioration attributed to disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.39', 'groupId': 'OG000', 'lowerLimit': '4.30', 'upperLimit': '6.08'}, {'value': '5.59', 'groupId': 'OG001', 'lowerLimit': '4.47', 'upperLimit': '7.89'}]}]}], 'analyses': [{'pValue': '0.1044', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.73', 'ciLowerLimit': '0.49', 'ciUpperLimit': '1.07', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 32.3 months', 'description': 'PFS was defined as time from randomization to the first occurrence of PD, as assessed by the investigator using RECIST v1.1, or death from any cause, whichever occurs first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters at prior timepoints (including baseline), in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants whether or not the participants received the assigned study treatment.'}, {'type': 'SECONDARY', 'title': 'OS in the FAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Atezolizumab + Carboplatin + Etoposide', 'description': 'Participants received atezolizumab, 1200 mg, followed by tiragolumab matching placebo, and carboplatin, at a dose targeting initial target AUC of 5 mg/mL/min as an IV infusion, Q3W, on Day 1 of each 21-day cycle along with etoposide, 100 mg/m\\^2, as an IV infusion on Days 1, 2 and 3 of each 21-day cycle for 4 cycles as induction treatment. (1 Cycle = 21 days). Participants then received maintenance treatment with atezolizumab, 1200 mg, followed by tiragolumab matching placebo given as an IV infusion, Q3W, from Day 1 of Cycle 5 until disease progression, loss of clinical benefit, unacceptable toxicity, or symptomatic deterioration attributed to disease progression.'}, {'id': 'OG001', 'title': 'Tiragolumab + Atezolizumab + Carboplatin + Etoposide', 'description': 'Participants received atezolizumab, 1200 mg, tiragolumab, 600 mg, and carboplatin, at a dose targeting initial target AUC of 5 mg/mL/min as an IV infusion, Q3W, on Day 1 along with etoposide, 100 mg/m\\^2, as an IV infusion on Days 1, 2 and 3 of each 21-day cycle for 4 cycles as induction treatment. (1 Cycle = 21 days). Participants then received maintenance treatment with atezolizumab, 1200 mg, followed by tiragolumab, 600 mg, given as an IV infusion, Q3W, from Day 1 of Cycle 5 until disease progression, loss of clinical benefit, unacceptable toxicity, or symptomatic deterioration attributed to disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.88', 'groupId': 'OG000', 'lowerLimit': '10.68', 'upperLimit': '22.44'}, {'value': '17.31', 'groupId': 'OG001', 'lowerLimit': '12.48', 'upperLimit': '20.37'}]}]}], 'analyses': [{'pValue': '0.9363', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.64', 'ciUpperLimit': '1.52', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 32.3 months', 'description': 'OS was defined as the time from the date of randomization to the date of death from any cause.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants whether or not the participants received the assigned study treatment.'}, {'type': 'SECONDARY', 'title': 'Investigator-Assessed Confirmed Objective Response Rate (ORR) in the PAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Atezolizumab + Carboplatin + Etoposide', 'description': 'Participants received atezolizumab, 1200 mg, followed by tiragolumab matching placebo, and carboplatin, at a dose targeting initial target AUC of 5 mg/mL/min as an IV infusion, Q3W, on Day 1 of each 21-day cycle along with etoposide, 100 mg/m\\^2, as an IV infusion on Days 1, 2 and 3 of each 21-day cycle for 4 cycles as induction treatment. (1 Cycle = 21 days). Participants then received maintenance treatment with atezolizumab, 1200 mg, followed by tiragolumab matching placebo given as an IV infusion, Q3W, from Day 1 of Cycle 5 until disease progression, loss of clinical benefit, unacceptable toxicity, or symptomatic deterioration attributed to disease progression.'}, {'id': 'OG001', 'title': 'Tiragolumab + Atezolizumab + Carboplatin + Etoposide', 'description': 'Participants received atezolizumab, 1200 mg, tiragolumab, 600 mg, and carboplatin, at a dose targeting initial target AUC of 5 mg/mL/min as an IV infusion, Q3W, on Day 1 along with etoposide, 100 mg/m\\^2, as an IV infusion on Days 1, 2 and 3 of each 21-day cycle for 4 cycles as induction treatment. (1 Cycle = 21 days). Participants then received maintenance treatment with atezolizumab, 1200 mg, followed by tiragolumab, 600 mg, given as an IV infusion, Q3W, from Day 1 of Cycle 5 until disease progression, loss of clinical benefit, unacceptable toxicity, or symptomatic deterioration attributed to disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': '58.9', 'groupId': 'OG000', 'lowerLimit': '45.01', 'upperLimit': '71.63'}, {'value': '81.5', 'groupId': 'OG001', 'lowerLimit': '68.13', 'upperLimit': '90.30'}]}]}], 'analyses': [{'pValue': '0.0136', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Overall Response Rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '22.55', 'ciLowerLimit': '4.12', 'ciUpperLimit': '39.03', 'statisticalMethod': 'Chi-square with Schouten Correction', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 32.3 months', 'description': 'ORR was defined as the percentage of participants with either a confirmed complete response (CR) or partial response (PR) on two consecutive occasions ≥4 weeks apart as assessed by investigator according to RECIST v.1.1. CR was defined as disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\<10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters in the absence of CR. Percentages have been rounded off.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'PAS included all randomized participants without presence or history of brain metastases at baseline.'}, {'type': 'SECONDARY', 'title': 'Investigator-Assessed Confirmed ORR in the FAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Atezolizumab + Carboplatin + Etoposide', 'description': 'Participants received atezolizumab, 1200 mg, followed by tiragolumab matching placebo, and carboplatin, at a dose targeting initial target AUC of 5 mg/mL/min as an IV infusion, Q3W, on Day 1 of each 21-day cycle along with etoposide, 100 mg/m\\^2, as an IV infusion on Days 1, 2 and 3 of each 21-day cycle for 4 cycles as induction treatment. (1 Cycle = 21 days). Participants then received maintenance treatment with atezolizumab, 1200 mg, followed by tiragolumab matching placebo given as an IV infusion, Q3W, from Day 1 of Cycle 5 until disease progression, loss of clinical benefit, unacceptable toxicity, or symptomatic deterioration attributed to disease progression.'}, {'id': 'OG001', 'title': 'Tiragolumab + Atezolizumab + Carboplatin + Etoposide', 'description': 'Participants received atezolizumab, 1200 mg, tiragolumab, 600 mg, and carboplatin, at a dose targeting initial target AUC of 5 mg/mL/min as an IV infusion, Q3W, on Day 1 along with etoposide, 100 mg/m\\^2, as an IV infusion on Days 1, 2 and 3 of each 21-day cycle for 4 cycles as induction treatment. (1 Cycle = 21 days). Participants then received maintenance treatment with atezolizumab, 1200 mg, followed by tiragolumab, 600 mg, given as an IV infusion, Q3W, from Day 1 of Cycle 5 until disease progression, loss of clinical benefit, unacceptable toxicity, or symptomatic deterioration attributed to disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': '59.7', 'groupId': 'OG000', 'lowerLimit': '46.46', 'upperLimit': '71.70'}, {'value': '77.0', 'groupId': 'OG001', 'lowerLimit': '64.20', 'upperLimit': '86.46'}]}]}], 'analyses': [{'pValue': '0.0493', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Overall Response Rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '17.37', 'ciLowerLimit': '-0.22', 'ciUpperLimit': '33.60', 'statisticalMethod': 'Chi-square with Schouten Correction', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 32.3 months', 'description': 'ORR was defined as the percentage of participants with either a confirmed CR or PR on two consecutive occasions ≥4 weeks apart as assessed by investigator according to RECIST v.1.1. CR was defined as disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters in the absence of CR. Percentages have been rounded off.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants whether or not the participants received the assigned study treatment.'}, {'type': 'SECONDARY', 'title': 'Investigator-Assessed Duration of Response (DOR) in the PAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Atezolizumab + Carboplatin + Etoposide', 'description': 'Participants received atezolizumab, 1200 mg, followed by tiragolumab matching placebo, and carboplatin, at a dose targeting initial target AUC of 5 mg/mL/min as an IV infusion, Q3W, on Day 1 of each 21-day cycle along with etoposide, 100 mg/m\\^2, as an IV infusion on Days 1, 2 and 3 of each 21-day cycle for 4 cycles as induction treatment. (1 Cycle = 21 days). Participants then received maintenance treatment with atezolizumab, 1200 mg, followed by tiragolumab matching placebo given as an IV infusion, Q3W, from Day 1 of Cycle 5 until disease progression, loss of clinical benefit, unacceptable toxicity, or symptomatic deterioration attributed to disease progression.'}, {'id': 'OG001', 'title': 'Tiragolumab + Atezolizumab + Carboplatin + Etoposide', 'description': 'Participants received atezolizumab, 1200 mg, tiragolumab, 600 mg, and carboplatin, at a dose targeting initial target AUC of 5 mg/mL/min as an IV infusion, Q3W, on Day 1 along with etoposide, 100 mg/m\\^2, as an IV infusion on Days 1, 2 and 3 of each 21-day cycle for 4 cycles as induction treatment. (1 Cycle = 21 days). Participants then received maintenance treatment with atezolizumab, 1200 mg, followed by tiragolumab, 600 mg, given as an IV infusion, Q3W, from Day 1 of Cycle 5 until disease progression, loss of clinical benefit, unacceptable toxicity, or symptomatic deterioration attributed to disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.45', 'groupId': 'OG000', 'lowerLimit': '3.91', 'upperLimit': '5.95'}, {'value': '5.52', 'groupId': 'OG001', 'lowerLimit': '4.11', 'upperLimit': '8.54'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 32.3 months', 'description': 'DOR was defined as the time interval from the date of the first occurrence of a confirmed objective response until the first date of PD as determined by the investigator using RECIST v1.1 or death from any cause, whichever occurs first. DOR was evaluated for participants who had an objective response of CR or PR. CR was defined as the disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters at prior timepoints (including baseline), in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'PAS included all randomized participants without presence or history of brain metastases at baseline. Overall number analyzed is the number of participants with objective response i.e., responders.'}, {'type': 'SECONDARY', 'title': 'Investigator-Assessed DOR in the FAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Atezolizumab + Carboplatin + Etoposide', 'description': 'Participants received atezolizumab, 1200 mg, followed by tiragolumab matching placebo, and carboplatin, at a dose targeting initial target AUC of 5 mg/mL/min as an IV infusion, Q3W, on Day 1 of each 21-day cycle along with etoposide, 100 mg/m\\^2, as an IV infusion on Days 1, 2 and 3 of each 21-day cycle for 4 cycles as induction treatment. (1 Cycle = 21 days). Participants then received maintenance treatment with atezolizumab, 1200 mg, followed by tiragolumab matching placebo given as an IV infusion, Q3W, from Day 1 of Cycle 5 until disease progression, loss of clinical benefit, unacceptable toxicity, or symptomatic deterioration attributed to disease progression.'}, {'id': 'OG001', 'title': 'Tiragolumab + Atezolizumab + Carboplatin + Etoposide', 'description': 'Participants received atezolizumab, 1200 mg, tiragolumab, 600 mg, and carboplatin, at a dose targeting initial target AUC of 5 mg/mL/min as an IV infusion, Q3W, on Day 1 along with etoposide, 100 mg/m\\^2, as an IV infusion on Days 1, 2 and 3 of each 21-day cycle for 4 cycles as induction treatment. (1 Cycle = 21 days). Participants then received maintenance treatment with atezolizumab, 1200 mg, followed by tiragolumab, 600 mg, given as an IV infusion, Q3W, from Day 1 of Cycle 5 until disease progression, loss of clinical benefit, unacceptable toxicity, or symptomatic deterioration attributed to disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.45', 'groupId': 'OG000', 'lowerLimit': '3.91', 'upperLimit': '6.14'}, {'value': '5.55', 'groupId': 'OG001', 'lowerLimit': '4.17', 'upperLimit': '7.92'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 32.3 months', 'description': 'DOR was defined as the time interval from the date of the first occurrence of a confirmed objective response until the first date of PD as determined by the investigator using RECIST v1.1 or death from any cause, whichever occurs first. DOR was evaluated for participants who had an objective response of CR or PR. CR was defined as the disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters at prior timepoints (including baseline), in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants whether or not the participants received the assigned study treatment. Overall number analyzed is the number of participants with objective response i.e., responders.'}, {'type': 'SECONDARY', 'title': 'Investigator-Assessed PFS Rates at 6 Months and 12 Months in the PAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Atezolizumab + Carboplatin + Etoposide', 'description': 'Participants received atezolizumab, 1200 mg, followed by tiragolumab matching placebo, and carboplatin, at a dose targeting initial target AUC of 5 mg/mL/min as an IV infusion, Q3W, on Day 1 of each 21-day cycle along with etoposide, 100 mg/m\\^2, as an IV infusion on Days 1, 2 and 3 of each 21-day cycle for 4 cycles as induction treatment. (1 Cycle = 21 days). Participants then received maintenance treatment with atezolizumab, 1200 mg, followed by tiragolumab matching placebo given as an IV infusion, Q3W, from Day 1 of Cycle 5 until disease progression, loss of clinical benefit, unacceptable toxicity, or symptomatic deterioration attributed to disease progression.'}, {'id': 'OG001', 'title': 'Tiragolumab + Atezolizumab + Carboplatin + Etoposide', 'description': 'Participants received atezolizumab, 1200 mg, tiragolumab, 600 mg, and carboplatin, at a dose targeting initial target AUC of 5 mg/mL/min as an IV infusion, Q3W, on Day 1 along with etoposide, 100 mg/m\\^2, as an IV infusion on Days 1, 2 and 3 of each 21-day cycle for 4 cycles as induction treatment. (1 Cycle = 21 days). Participants then received maintenance treatment with atezolizumab, 1200 mg, followed by tiragolumab, 600 mg, given as an IV infusion, Q3W, from Day 1 of Cycle 5 until disease progression, loss of clinical benefit, unacceptable toxicity, or symptomatic deterioration attributed to disease progression.'}], 'classes': [{'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '39.11', 'groupId': 'OG000', 'lowerLimit': '26.09', 'upperLimit': '52.14'}, {'value': '47.20', 'groupId': 'OG001', 'lowerLimit': '33.76', 'upperLimit': '60.64'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.24', 'groupId': 'OG000', 'lowerLimit': '1.91', 'upperLimit': '18.57'}, {'value': '27.69', 'groupId': 'OG001', 'lowerLimit': '15.51', 'upperLimit': '39.87'}]}]}], 'analyses': [{'pValue': '0.3968', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in EFR at Month 6', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.09', 'ciLowerLimit': '-10.62', 'ciUpperLimit': '26.81', 'groupDescription': '6 Months', 'statisticalMethod': 'Z-test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0205', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in EFR at Month 12', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '17.45', 'ciLowerLimit': '2.69', 'ciUpperLimit': '32.21', 'groupDescription': '12 Months', 'statisticalMethod': 'Z-test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6, Month 12', 'description': 'PFS = time from randomization to the first occurrence of PD, per investigator per RECIST v1.1/ death from any cause, whichever occurs first. PFS rate at 6 and 12 = the percentage of participants who have not experienced PD per investigator per RECIST v1.1/ death from any cause at 6 and 12 months. PD =at least a 20% increase in the sum of diameters of target lesions, taking as reference the SOD at prior timepoints (including baseline), in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Kaplan-Meier (K-M) method was used to estimate PFS rate. Percentages have been rounded off. Abbreviation used in Statistical Analysis section - Event Free Rate - EFR. The event free rate (for example the inv-PFS free rate of 10.24% at 12-months) used the K-M approach to estimate, which accounts for the censoring, the specific nature of time-to-event data. Naive calculation based on patient proportion will introduce bias.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'PAS included all randomized participants without presence or history of brain metastases at baseline. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available at the specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Investigator-Assessed PFS Rates at 6 Months and 12 Months in the FAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Atezolizumab + Carboplatin + Etoposide', 'description': 'Participants received atezolizumab, 1200 mg, followed by tiragolumab matching placebo, and carboplatin, at a dose targeting initial target AUC of 5 mg/mL/min as an IV infusion, Q3W, on Day 1 of each 21-day cycle along with etoposide, 100 mg/m\\^2, as an IV infusion on Days 1, 2 and 3 of each 21-day cycle for 4 cycles as induction treatment. (1 Cycle = 21 days). Participants then received maintenance treatment with atezolizumab, 1200 mg, followed by tiragolumab matching placebo given as an IV infusion, Q3W, from Day 1 of Cycle 5 until disease progression, loss of clinical benefit, unacceptable toxicity, or symptomatic deterioration attributed to disease progression.'}, {'id': 'OG001', 'title': 'Tiragolumab + Atezolizumab + Carboplatin + Etoposide', 'description': 'Participants received atezolizumab, 1200 mg, tiragolumab, 600 mg, and carboplatin, at a dose targeting initial target AUC of 5 mg/mL/min as an IV infusion, Q3W, on Day 1 along with etoposide, 100 mg/m\\^2, as an IV infusion on Days 1, 2 and 3 of each 21-day cycle for 4 cycles as induction treatment. (1 Cycle = 21 days). Participants then received maintenance treatment with atezolizumab, 1200 mg, followed by tiragolumab, 600 mg, given as an IV infusion, Q3W, from Day 1 of Cycle 5 until disease progression, loss of clinical benefit, unacceptable toxicity, or symptomatic deterioration attributed to disease progression.'}], 'classes': [{'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '38.52', 'groupId': 'OG000', 'lowerLimit': '26.20', 'upperLimit': '50.84'}, {'value': '46.71', 'groupId': 'OG001', 'lowerLimit': '34.08', 'upperLimit': '59.33'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.70', 'groupId': 'OG000', 'lowerLimit': '4.09', 'upperLimit': '21.31'}, {'value': '26.06', 'groupId': 'OG001', 'lowerLimit': '14.84', 'upperLimit': '37.29'}]}]}], 'analyses': [{'pValue': '0.3633', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in EFR at Month 6', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.18', 'ciLowerLimit': '-9.46', 'ciUpperLimit': '25.82', 'groupDescription': '6 Months', 'statisticalMethod': 'Z-test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0642', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in EFR at Month12', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.36', 'ciLowerLimit': '-0.79', 'ciUpperLimit': '27.51', 'groupDescription': '12 Months', 'statisticalMethod': 'Z-test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6, Month 12', 'description': 'PFS was defined as time from randomization to the first occurrence of PD, as assessed by the investigator using RECIST v1.1, or death from any cause, whichever occurs first. PFS rate at 6 months and 12 months defined as the percentage of participants who have not experienced PD as determined by the investigator according to RECIST v1.1 or death from any cause at 6 and 12 months. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters at prior timepoints (including baseline), in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. K-M method was used to estimate PFS rate. Percentages have been rounded off. The event free rate used the K-M approach to estimate, which accounts for the censoring, the specific nature of time-to-event data. Naive calculation based on patient proportion will introduce bias.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants whether or not the participants received the assigned study treatment. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available at the specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Overall Survival Rate at 12 Months and 24 Months in the PAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Atezolizumab + Carboplatin + Etoposide', 'description': 'Participants received atezolizumab, 1200 mg, followed by tiragolumab matching placebo, and carboplatin, at a dose targeting initial target AUC of 5 mg/mL/min as an IV infusion, Q3W, on Day 1 of each 21-day cycle along with etoposide, 100 mg/m\\^2, as an IV infusion on Days 1, 2 and 3 of each 21-day cycle for 4 cycles as induction treatment. (1 Cycle = 21 days). Participants then received maintenance treatment with atezolizumab, 1200 mg, followed by tiragolumab matching placebo given as an IV infusion, Q3W, from Day 1 of Cycle 5 until disease progression, loss of clinical benefit, unacceptable toxicity, or symptomatic deterioration attributed to disease progression.'}, {'id': 'OG001', 'title': 'Tiragolumab + Atezolizumab + Carboplatin + Etoposide', 'description': 'Participants received atezolizumab, 1200 mg, tiragolumab, 600 mg, and carboplatin, at a dose targeting initial target AUC of 5 mg/mL/min as an IV infusion, Q3W, on Day 1 along with etoposide, 100 mg/m\\^2, as an IV infusion on Days 1, 2 and 3 of each 21-day cycle for 4 cycles as induction treatment. (1 Cycle = 21 days). Participants then received maintenance treatment with atezolizumab, 1200 mg, followed by tiragolumab, 600 mg, given as an IV infusion, Q3W, from Day 1 of Cycle 5 until disease progression, loss of clinical benefit, unacceptable toxicity, or symptomatic deterioration attributed to disease progression.'}], 'classes': [{'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '51.50', 'groupId': 'OG000', 'lowerLimit': '38.09', 'upperLimit': '64.92'}, {'value': '71.97', 'groupId': 'OG001', 'lowerLimit': '59.92', 'upperLimit': '84.02'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '32.94', 'groupId': 'OG000', 'lowerLimit': '19.97', 'upperLimit': '45.92'}, {'value': '32.44', 'groupId': 'OG001', 'lowerLimit': '19.55', 'upperLimit': '45.33'}]}]}], 'analyses': [{'pValue': '0.0261', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in EFR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '20.47', 'ciLowerLimit': '2.43', 'ciUpperLimit': '38.50', 'groupDescription': '12 Months', 'statisticalMethod': 'Z-test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9572', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in EFR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.50', 'ciLowerLimit': '-18.79', 'ciUpperLimit': '17.79', 'groupDescription': '24 Months', 'statisticalMethod': 'Z-test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Month 12, Month 24', 'description': 'OS was defined as the time from the date of randomization to the date of death from any cause. OS rate at 12 months and 24 months was defined as the percentage of participants who did not experience death from any cause at 12 months and 24 months. Percentages have been rounded off.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'PAS included all randomized participants without presence or history of brain metastases at baseline. Overall number of participants analyzed is the number of participants with data available for analyses. Number analyzed is the number of participants with data available at the specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Overall Survival Rates at 12 Months and 24 Months in the FAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Atezolizumab + Carboplatin + Etoposide', 'description': 'Participants received atezolizumab, 1200 mg, followed by tiragolumab matching placebo, and carboplatin, at a dose targeting initial target AUC of 5 mg/mL/min as an IV infusion, Q3W, on Day 1 of each 21-day cycle along with etoposide, 100 mg/m\\^2, as an IV infusion on Days 1, 2 and 3 of each 21-day cycle for 4 cycles as induction treatment. (1 Cycle = 21 days). Participants then received maintenance treatment with atezolizumab, 1200 mg, followed by tiragolumab matching placebo given as an IV infusion, Q3W, from Day 1 of Cycle 5 until disease progression, loss of clinical benefit, unacceptable toxicity, or symptomatic deterioration attributed to disease progression.'}, {'id': 'OG001', 'title': 'Tiragolumab + Atezolizumab + Carboplatin + Etoposide', 'description': 'Participants received atezolizumab, 1200 mg, tiragolumab, 600 mg, and carboplatin, at a dose targeting initial target AUC of 5 mg/mL/min as an IV infusion, Q3W, on Day 1 along with etoposide, 100 mg/m\\^2, as an IV infusion on Days 1, 2 and 3 of each 21-day cycle for 4 cycles as induction treatment. (1 Cycle = 21 days). Participants then received maintenance treatment with atezolizumab, 1200 mg, followed by tiragolumab, 600 mg, given as an IV infusion, Q3W, from Day 1 of Cycle 5 until disease progression, loss of clinical benefit, unacceptable toxicity, or symptomatic deterioration attributed to disease progression.'}], 'classes': [{'title': '12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '54.73', 'groupId': 'OG000', 'lowerLimit': '42.07', 'upperLimit': '67.39'}, {'value': '68.61', 'groupId': 'OG001', 'lowerLimit': '56.91', 'upperLimit': '80.32'}]}]}, {'title': '24 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '34.65', 'groupId': 'OG000', 'lowerLimit': '22.24', 'upperLimit': '47.05'}, {'value': '32.11', 'groupId': 'OG001', 'lowerLimit': '20.06', 'upperLimit': '44.16'}]}]}], 'analyses': [{'pValue': '0.1145', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in EFR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.88', 'ciLowerLimit': '-3.36', 'ciUpperLimit': '31.12', 'groupDescription': '12 Months', 'statisticalMethod': 'Z-test', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7734', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in EFR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.54', 'ciLowerLimit': '-19.83', 'ciUpperLimit': '14.75', 'groupDescription': '24 Months', 'statisticalMethod': 'Z-test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Month 12, Month 24', 'description': 'OS was defined as the time from the date of randomization to the date of death from any cause. OS rate at 12 months and 24 months was defined as the percentage of participants who did not experience death from any cause at 12 months and 24 months. Percentages have been rounded off.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants whether or not the participants received the assigned study treatment. Overall number of participants analyzed is the number of participants with data available for analyses. Number analyzed is the number of participants with data available at the specified timepoint.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Adverse Events', 'timeFrame': 'Up to 66 months', 'description': 'An AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An adverse event can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product, any new disease or exacerbation of an existing disease (a worsening in the character, frequency, or severity of a known condition), recurrence of an intermittent medical condition not present at baseline, any deterioration in a laboratory value or other clinical test that is associated with symptoms or leads to a change in study treatment or concomitant treatment or discontinuation from study drug or adverse events that are related to a protocol-mandated intervention, including those that occur prior to assignment of study treatment.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2026-04'}, {'type': 'SECONDARY', 'title': 'Time to Confirmed Deterioration (TTCD) Assessed Using European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core (QLQ-C30) Score in the PAS', 'timeFrame': 'Up to approximately 66 months', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2026-04'}, {'type': 'SECONDARY', 'title': 'TTCD Assessed Using EORTC QLQ-C30 Score in the FAS', 'timeFrame': 'Up to approximately 66 months', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2026-04'}, {'type': 'SECONDARY', 'title': 'Maximum Plasma Concentration (Cmax) of Tiragolumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tiragolumab + Atezolizumab + Carboplatin + Etoposide', 'description': 'Participants received atezolizumab, 1200 mg, tiragolumab, 600 mg, and carboplatin, at a dose targeting initial target AUC of 5 mg/mL/min as an IV infusion, Q3W, on Day 1 along with etoposide, 100 mg/m\\^2, as an IV infusion on Days 1, 2 and 3 of each 21-day cycle for 4 cycles as induction treatment. (1 Cycle = 21 days). Participants then received maintenance treatment with atezolizumab, 1200 mg, followed by tiragolumab, 600 mg, given as an IV infusion, Q3W, from Day 1 of Cycle 5 until disease progression, loss of clinical benefit, unacceptable toxicity, or symptomatic deterioration attributed to disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': '175', 'spread': '19.3', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 1, 30 mins post end of infusion (EOI) (cycle length= 21 days)', 'description': 'Only sparse pharmacokinetic samples were collected in this study. With the focus on only Cmax and Cmin, there are no additional PK timepoints not reported', 'unitOfMeasure': 'microgram per milliliter (μg/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK-evaluable population included all participants who received at least one dose of tiragolumab treatment and who have at least one post-baseline PK sample available.'}, {'type': 'SECONDARY', 'title': 'Minimum Plasma Concentration (Cmin) of Tiragolumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tiragolumab + Atezolizumab + Carboplatin + Etoposide', 'description': 'Participants received atezolizumab, 1200 mg, tiragolumab, 600 mg, and carboplatin, at a dose targeting initial target AUC of 5 mg/mL/min as an IV infusion, Q3W, on Day 1 along with etoposide, 100 mg/m\\^2, as an IV infusion on Days 1, 2 and 3 of each 21-day cycle for 4 cycles as induction treatment. (1 Cycle = 21 days). Participants then received maintenance treatment with atezolizumab, 1200 mg, followed by tiragolumab, 600 mg, given as an IV infusion, Q3W, from Day 1 of Cycle 5 until disease progression, loss of clinical benefit, unacceptable toxicity, or symptomatic deterioration attributed to disease progression.'}], 'classes': [{'title': 'Pre-dose: Cycle 2 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '27.0', 'spread': '51.6', 'groupId': 'OG000'}]}]}, {'title': 'Pre-dose: Cycle 3 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '39.4', 'spread': '79.9', 'groupId': 'OG000'}]}]}, {'title': 'Pre-dose: Cycle 4 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '48.0', 'spread': '40.0', 'groupId': 'OG000'}]}]}, {'title': 'Pre-dose: Cycle 8 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '64.5', 'spread': '44.7', 'groupId': 'OG000'}]}]}, {'title': 'Pre-dose: Cycle 12 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '53.6', 'spread': '193', 'groupId': 'OG000'}]}]}, {'title': 'Pre-dose: Cycle 16 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '71.9', 'spread': '58.8', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, Day 1 of Cycles 2, 3, 4, 8, 12, 16 (cycle length= 21 days)', 'unitOfMeasure': 'μg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK-evaluable population included all participants who received at least one dose of tiragolumab treatment and who have at least one post-baseline PK sample available. Overall number of participants analyzed is the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analyses at the specified timepoints.'}, {'type': 'SECONDARY', 'title': 'Cmax of Atezolizumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo + Atezolizumab + Carboplatin + Etoposide', 'description': 'Participants received atezolizumab, 1200 mg, followed by tiragolumab matching placebo, and carboplatin, at a dose targeting initial target AUC of 5 mg/mL/min as an IV infusion, Q3W, on Day 1 of each 21-day cycle along with etoposide, 100 mg/m\\^2, as an IV infusion on Days 1, 2 and 3 of each 21-day cycle for 4 cycles as induction treatment. (1 Cycle = 21 days). Participants then received maintenance treatment with atezolizumab, 1200 mg, followed by tiragolumab matching placebo given as an IV infusion, Q3W, from Day 1 of Cycle 5 until disease progression, loss of clinical benefit, unacceptable toxicity, or symptomatic deterioration attributed to disease progression.'}, {'id': 'OG001', 'title': 'Tiragolumab + Atezolizumab + Carboplatin + Etoposide', 'description': 'Participants received atezolizumab, 1200 mg, tiragolumab, 600 mg, and carboplatin, at a dose targeting initial target AUC of 5 mg/mL/min as an IV infusion, Q3W, on Day 1 along with etoposide, 100 mg/m\\^2, as an IV infusion on Days 1, 2 and 3 of each 21-day cycle for 4 cycles as induction treatment. (1 Cycle = 21 days). Participants then received maintenance treatment with atezolizumab, 1200 mg, followed by tiragolumab, 600 mg, given as an IV infusion, Q3W, from Day 1 of Cycle 5 until disease progression, loss of clinical benefit, unacceptable toxicity, or symptomatic deterioration attributed to disease progression.'}], 'classes': [{'categories': [{'measurements': [{'value': '355', 'spread': '28.9', 'groupId': 'OG000'}, {'value': '370', 'spread': '36.5', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1 Day 1, 30 mins post EOI (cycle length= 21 days)', 'unitOfMeasure': 'microgram per milliliter (μg/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Atezolizumab PK evaluable set included all participants who received at least one dose of atezolizumab treatment and who have at least one post-baseline PK sample available.'}, {'type': 'SECONDARY', 'title': 'Cmin of Atezolizumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tiragolumab + Atezolizumab + Carboplatin + Etoposide', 'description': 'Participants received atezolizumab, 1200 mg, tiragolumab, 600 mg, and carboplatin, at a dose targeting initial target AUC of 5 mg/mL/min as an IV infusion, Q3W, on Day 1 along with etoposide, 100 mg/m\\^2, as an IV infusion on Days 1, 2 and 3 of each 21-day cycle for 4 cycles as induction treatment. (1 Cycle = 21 days). Participants then received maintenance treatment with atezolizumab, 1200 mg, followed by tiragolumab, 600 mg, given as an IV infusion, Q3W, from Day 1 of Cycle 5 until disease progression, loss of clinical benefit, unacceptable toxicity, or symptomatic deterioration attributed to disease progression.'}, {'id': 'OG001', 'title': 'Placebo + Atezolizumab + Carboplatin + Etoposide', 'description': 'Participants received atezolizumab, 1200 mg, followed by tiragolumab matching placebo, and carboplatin, at a dose targeting initial target AUC of 5 mg/mL/min as an IV infusion, Q3W, on Day 1 of each 21-day cycle along with etoposide, 100 mg/m\\^2, as an IV infusion on Days 1, 2 and 3 of each 21-day cycle for 4 cycles as induction treatment. (1 Cycle = 21 days). Participants then received maintenance treatment with atezolizumab, 1200 mg, followed by tiragolumab matching placebo given as an IV infusion, Q3W, from Day 1 of Cycle 5 until disease progression, loss of clinical benefit, unacceptable toxicity, or symptomatic deterioration attributed to disease progression.'}], 'classes': [{'title': 'Pre-dose: Cycle 2 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '63.8', 'spread': '76.5', 'groupId': 'OG000'}, {'value': '68.1', 'spread': '33.7', 'groupId': 'OG001'}]}]}, {'title': 'Pre-dose: Cycle 3 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '88.5', 'spread': '166', 'groupId': 'OG000'}, {'value': '96.6', 'spread': '46.6', 'groupId': 'OG001'}]}]}, {'title': 'Pre-dose: Cycle 4 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '111', 'spread': '88.6', 'groupId': 'OG000'}, {'value': '99.2', 'spread': '62.7', 'groupId': 'OG001'}]}]}, {'title': 'Pre-dose: Cycle 8 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '151', 'spread': '41.6', 'groupId': 'OG000'}, {'value': '151', 'spread': '31.8', 'groupId': 'OG001'}]}]}, {'title': 'Pre-dose: Cycle 12 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '139', 'spread': '155', 'groupId': 'OG000'}, {'value': '172', 'spread': '35.0', 'groupId': 'OG001'}]}]}, {'title': 'Pre-dose: Cycle 16 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '177', 'spread': '55.0', 'groupId': 'OG000'}, {'value': '169', 'spread': '30.1', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, Day 1 of Cycles 2, 3, 4, 8, 12, 16 (cycle length= 21 days)', 'unitOfMeasure': 'μg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Atezolizumab PK evaluable set included all participants who received at least one dose of atezolizumab treatment and who have at least one post-baseline PK sample available. Overall number of participants analyzed is the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analyses at the specified timepoints.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Anti-Drug Antibodies (ADAs) to Tiragolumab', 'timeFrame': 'Predose on Day 1 of Cycles (each cycle=21 days) 1, 2, 3, 4, 8, 12, 16 and at TD visit (up to approximately 49 months)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2026-04'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo + Atezolizumab + Carboplatin + Etoposide', 'description': 'Participants received atezolizumab, 1200 milligrams (mg), followed by tiragolumab matching placebo, and carboplatin, at a dose targeting initial target area under the concentration-time curve (AUC) of 5 milligrams per mililiter per minute (mg/mL/min) as an intravenous (IV) infusion, once every 3 weeks (Q3W), on Day 1 of each 21-day cycle along with etoposide, 100 milligrams per square meter (mg/m\\^2), as an IV infusion on Days 1, 2 and 3 of each 21-day cycle for 4 cycles as induction treatment. (1 Cycle = 21 days). Participants then received maintenance treatment with atezolizumab, 1200 mg, followed by tiragolumab matching placebo given as an IV infusion, Q3W, from Day 1 of Cycle 5 until disease progression, loss of clinical benefit, unacceptable toxicity, or symptomatic deterioration attributed to disease progression.'}, {'id': 'FG001', 'title': 'Tiragolumab + Atezolizumab + Carboplatin + Etoposide', 'description': 'Participants received atezolizumab, 1200 mg, tiragolumab, 600 mg, and carboplatin, at a dose targeting initial target AUC of 5 mg/mL/min as an IV infusion, Q3W, on Day 1 along with etoposide, 100 mg/m\\^2, as an IV infusion on Days 1, 2 and 3 of each 21-day cycle for 4 cycles as induction treatment. (1 Cycle = 21 days). Participants then received maintenance treatment with atezolizumab, 1200 mg, followed by tiragolumab, 600 mg, given as an IV infusion, Q3W, from Day 1 of Cycle 5 until disease progression, loss of clinical benefit, unacceptable toxicity, or symptomatic deterioration attributed to disease progression.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}, {'groupId': 'FG001', 'numSubjects': '61'}]}, {'type': 'Safety Evaluable Set', 'comment': 'Safety Evaluable Set included all randomized participants who received at least one dose of study treatment.', 'achievements': [{'comment': '1 participant enrolled in the tiragolumab arm did not receive any dose of tiragolumab and was moved to the placebo arm for safety analysis.', 'groupId': 'FG000', 'numSubjects': '63'}, {'comment': '1 participant enrolled in the tiragolumab arm did not receive any dose of tiragolumab and was moved to the placebo arm for safety analysis.', 'groupId': 'FG001', 'numSubjects': '60'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}, {'groupId': 'FG001', 'numSubjects': '61'}]}], 'dropWithdraws': [{'type': 'Site Terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '44'}]}, {'type': 'Ongoing in study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '15'}]}]}], 'recruitmentDetails': 'Participants were enrolled at 17 investigative sites in China. This study is still ongoing.', 'preAssignmentDetails': 'A total of 123 participants were randomized in the study in a 1:1 ratio to receive tiragolumab plus atezolizumab and carboplatin + etoposide (CE) or placebo plus atezolizumab and CE. One participant from the tiragolumab arm did not receive tiragolumab and hence was included in the placebo arm group for safety analysis.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '123', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo + Atezolizumab + Carboplatin + Etoposide', 'description': 'Participants received atezolizumab, 1200 mg, followed by tiragolumab matching placebo, and carboplatin, at a dose targeting initial target AUC of 5 mg/mL/min as an IV infusion, Q3W, on Day 1 of each 21-day cycle along with etoposide, 100 mg/m\\^2, as an IV infusion on Days 1, 2 and 3 of each 21-day cycle for 4 cycles as induction treatment. (1 Cycle = 21 days). Participants then received maintenance treatment with atezolizumab, 1200 mg, followed by tiragolumab matching placebo given as an IV infusion, Q3W, from Day 1 of Cycle 5 until disease progression, loss of clinical benefit, unacceptable toxicity, or symptomatic deterioration attributed to disease progression.'}, {'id': 'BG001', 'title': 'Tiragolumab + Atezolizumab + Carboplatin + Etoposide', 'description': 'Participants received atezolizumab, 1200 mg, tiragolumab, 600 mg, and carboplatin, at a dose targeting initial target AUC of 5 mg/mL/min as an IV infusion, Q3W, on Day 1 along with etoposide, 100 mg/m\\^2, as an IV infusion on Days 1, 2 and 3 of each 21-day cycle for 4 cycles as induction treatment. (1 Cycle = 21 days). Participants then received maintenance treatment with atezolizumab, 1200 mg, followed by tiragolumab, 600 mg, given as an IV infusion, Q3W, from Day 1 of Cycle 5 until disease progression, loss of clinical benefit, unacceptable toxicity, or symptomatic deterioration attributed to disease progression.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.9', 'spread': '8.0', 'groupId': 'BG000'}, {'value': '62.0', 'spread': '7.8', 'groupId': 'BG001'}, {'value': '61.4', 'spread': '7.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '123', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '123', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full Analysis Set (FAS) included all randomized participants whether or not the participants received the assigned study treatment.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-12-14', 'size': 3046960, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-08-26T02:27', 'hasProtocol': True}, {'date': '2022-05-27', 'size': 690461, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-08-26T02:27', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 123}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-12-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'dispFirstSubmitDate': '2024-08-27', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-15', 'studyFirstSubmitDate': '2020-12-07', 'resultsFirstSubmitDate': '2025-08-26', 'studyFirstSubmitQcDate': '2020-12-07', 'dispFirstPostDateStruct': {'date': '2025-10-29', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2025-10-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-10-15', 'studyFirstPostDateStruct': {'date': '2020-12-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-10-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Investigator-Assessed Progression-Free Survival (PFS) in the Primary Analysis Set (PAS)', 'timeFrame': 'Up to 32.3 months', 'description': 'PFS was defined as time from randomization to the first occurrence of disease progression (PD), as assessed by the investigator using Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1), or death from any cause, whichever occurs first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters at prior timepoints (including baseline), in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm).'}, {'measure': 'Overall Survival (OS) in the PAS', 'timeFrame': 'Up to 32.3 months', 'description': 'OS was defined as the time from the date of randomization to the date of death from any cause.'}], 'secondaryOutcomes': [{'measure': 'PFS in the FAS', 'timeFrame': 'Up to 32.3 months', 'description': 'PFS was defined as time from randomization to the first occurrence of PD, as assessed by the investigator using RECIST v1.1, or death from any cause, whichever occurs first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters at prior timepoints (including baseline), in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.'}, {'measure': 'OS in the FAS', 'timeFrame': 'Up to 32.3 months', 'description': 'OS was defined as the time from the date of randomization to the date of death from any cause.'}, {'measure': 'Investigator-Assessed Confirmed Objective Response Rate (ORR) in the PAS', 'timeFrame': 'Up to 32.3 months', 'description': 'ORR was defined as the percentage of participants with either a confirmed complete response (CR) or partial response (PR) on two consecutive occasions ≥4 weeks apart as assessed by investigator according to RECIST v.1.1. CR was defined as disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\<10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters in the absence of CR. Percentages have been rounded off.'}, {'measure': 'Investigator-Assessed Confirmed ORR in the FAS', 'timeFrame': 'Up to 32.3 months', 'description': 'ORR was defined as the percentage of participants with either a confirmed CR or PR on two consecutive occasions ≥4 weeks apart as assessed by investigator according to RECIST v.1.1. CR was defined as disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters in the absence of CR. Percentages have been rounded off.'}, {'measure': 'Investigator-Assessed Duration of Response (DOR) in the PAS', 'timeFrame': 'Up to 32.3 months', 'description': 'DOR was defined as the time interval from the date of the first occurrence of a confirmed objective response until the first date of PD as determined by the investigator using RECIST v1.1 or death from any cause, whichever occurs first. DOR was evaluated for participants who had an objective response of CR or PR. CR was defined as the disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters at prior timepoints (including baseline), in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.'}, {'measure': 'Investigator-Assessed DOR in the FAS', 'timeFrame': 'Up to 32.3 months', 'description': 'DOR was defined as the time interval from the date of the first occurrence of a confirmed objective response until the first date of PD as determined by the investigator using RECIST v1.1 or death from any cause, whichever occurs first. DOR was evaluated for participants who had an objective response of CR or PR. CR was defined as the disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters at prior timepoints (including baseline), in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.'}, {'measure': 'Investigator-Assessed PFS Rates at 6 Months and 12 Months in the PAS', 'timeFrame': 'Month 6, Month 12', 'description': 'PFS = time from randomization to the first occurrence of PD, per investigator per RECIST v1.1/ death from any cause, whichever occurs first. PFS rate at 6 and 12 = the percentage of participants who have not experienced PD per investigator per RECIST v1.1/ death from any cause at 6 and 12 months. PD =at least a 20% increase in the sum of diameters of target lesions, taking as reference the SOD at prior timepoints (including baseline), in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Kaplan-Meier (K-M) method was used to estimate PFS rate. Percentages have been rounded off. Abbreviation used in Statistical Analysis section - Event Free Rate - EFR. The event free rate (for example the inv-PFS free rate of 10.24% at 12-months) used the K-M approach to estimate, which accounts for the censoring, the specific nature of time-to-event data. Naive calculation based on patient proportion will introduce bias.'}, {'measure': 'Investigator-Assessed PFS Rates at 6 Months and 12 Months in the FAS', 'timeFrame': 'Month 6, Month 12', 'description': 'PFS was defined as time from randomization to the first occurrence of PD, as assessed by the investigator using RECIST v1.1, or death from any cause, whichever occurs first. PFS rate at 6 months and 12 months defined as the percentage of participants who have not experienced PD as determined by the investigator according to RECIST v1.1 or death from any cause at 6 and 12 months. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters at prior timepoints (including baseline), in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. K-M method was used to estimate PFS rate. Percentages have been rounded off. The event free rate used the K-M approach to estimate, which accounts for the censoring, the specific nature of time-to-event data. Naive calculation based on patient proportion will introduce bias.'}, {'measure': 'Overall Survival Rate at 12 Months and 24 Months in the PAS', 'timeFrame': 'Month 12, Month 24', 'description': 'OS was defined as the time from the date of randomization to the date of death from any cause. OS rate at 12 months and 24 months was defined as the percentage of participants who did not experience death from any cause at 12 months and 24 months. Percentages have been rounded off.'}, {'measure': 'Overall Survival Rates at 12 Months and 24 Months in the FAS', 'timeFrame': 'Month 12, Month 24', 'description': 'OS was defined as the time from the date of randomization to the date of death from any cause. OS rate at 12 months and 24 months was defined as the percentage of participants who did not experience death from any cause at 12 months and 24 months. Percentages have been rounded off.'}, {'measure': 'Percentage of Participants With Adverse Events', 'timeFrame': 'Up to 66 months', 'description': 'An AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An adverse event can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product, any new disease or exacerbation of an existing disease (a worsening in the character, frequency, or severity of a known condition), recurrence of an intermittent medical condition not present at baseline, any deterioration in a laboratory value or other clinical test that is associated with symptoms or leads to a change in study treatment or concomitant treatment or discontinuation from study drug or adverse events that are related to a protocol-mandated intervention, including those that occur prior to assignment of study treatment.'}, {'measure': 'Time to Confirmed Deterioration (TTCD) Assessed Using European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core (QLQ-C30) Score in the PAS', 'timeFrame': 'Up to approximately 66 months'}, {'measure': 'TTCD Assessed Using EORTC QLQ-C30 Score in the FAS', 'timeFrame': 'Up to approximately 66 months'}, {'measure': 'Maximum Plasma Concentration (Cmax) of Tiragolumab', 'timeFrame': 'Cycle 1 Day 1, 30 mins post end of infusion (EOI) (cycle length= 21 days)', 'description': 'Only sparse pharmacokinetic samples were collected in this study. With the focus on only Cmax and Cmin, there are no additional PK timepoints not reported'}, {'measure': 'Minimum Plasma Concentration (Cmin) of Tiragolumab', 'timeFrame': 'Pre-dose, Day 1 of Cycles 2, 3, 4, 8, 12, 16 (cycle length= 21 days)'}, {'measure': 'Cmax of Atezolizumab', 'timeFrame': 'Cycle 1 Day 1, 30 mins post EOI (cycle length= 21 days)'}, {'measure': 'Cmin of Atezolizumab', 'timeFrame': 'Pre-dose, Day 1 of Cycles 2, 3, 4, 8, 12, 16 (cycle length= 21 days)'}, {'measure': 'Percentage of Participants With Anti-Drug Antibodies (ADAs) to Tiragolumab', 'timeFrame': 'Predose on Day 1 of Cycles (each cycle=21 days) 1, 2, 3, 4, 8, 12, 16 and at TD visit (up to approximately 49 months)'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Small Cell Lung Carcinoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this multicenter study in China is to evaluate the safety and efficacy of tiragolumab plus atezolizumab and carboplatin and etoposide (CE) compared with placebo plus atezolizumab and CE in participants with untreated extensive-stage small cell lung cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1\n* Histologically or cytologically confirmed Extensive-Stage Small Cell Lung Cancer (ES-SCLC) per the modified Veterans Administration Lung Study Group (VALG) staging system\n* No prior systemic treatment for ES-SCLC\n* For participants who have received prior chemoradiotherapy for limited-stage SCLC must have had treatment with curative intent and a treatment-free interval of at least 6 months between the last dose/cycle of chemotherapy, thoracic radiotherapy, or chemoradiotherapy and the diagnosis of ES-SCLC\n* Measurable diseases as defined by RECIST v1.1\n* Submission of a pre-treatment tumor tissue sample\n* Adequate hematologic and end-organ function\n* Participants not receiving therapeutic anticoagulation with International Normalized Ratio (INR) and Activated Clotting Time (aPTT) \\</= 1.5 x ULN\n* Participants receiving therapeutic anticoagulation: stable anticoagulant regimen\n* Negative Human Immunodeficiency Virus (HIV) test at screening\n* Negative hepatitis B surface antigen (HBsAg) test at screening\n* Positive hepatitis B surface antibody (HBsAb) test at screening, or negative HBsAb at screening accompanied by either of the following: negative total hepatitis B core antibody (HBcAb) and/or positive total HBcAb test followed by a negative hepatitis B virus (HBV) DNA test\n* Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test\n* Negative Epstein-Barr virus (EBV) viral capsid antigen (VCA) IgM test or negative EBV polymerase chain reaction (PCR) test at screening\n* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agreement to refrain from donating eggs\n* For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating sperm.\n\nExclusion Criteria:\n\n* Symptomatic or actively progressing central nervous system (CNS) metastases\n* Spinal cord compression\n* Leptomeningeal disease\n* Uncontrolled pleural effusion, pericardial effusion, or ascites\n* Uncontrolled or symptomatic hypercalcemia\n* Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, cirrhosis, and inherited liver disease, or current alcohol abuse\n* Malignancies other than SCLC within 5 years prior to randomization\n* Active or history of autoimmune disease or immune deficiencies\n* History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest Computer Tomography (CT) scan\n* Known active tuberculosis, Current treatment with anti-viral therapy for HBV or HCV\n* Severe chronic or active infection\n* Treatment with therapeutic oral or IV antibiotics\n* Significant cardiovascular disease\n* Major surgical procedure other than for diagnosis\n* Prior allogeneic bone marrow transplantation or solid organ transplant\n* Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition\n* Administration of a live, attenuated vaccine\n* Prior treatment with CD137 agonists, T-cell co-stimulating, or immune checkpoint blockade therapies\n* Treatment with systemic immunostimulatory agents\n* Treatment with systemic immunosuppressive medications\n* History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins\n* Known hypersensitivity to Chinese Hamster Ovary (CHO) cell products or to any component of the tiragolumab or atezolizumab formulations\n* History of allergic reactions to carboplatin or etoposide\n* Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after the final dose of atezolizumab or within 90 days after the final dose of tiragolumab or for 6 months after the final dose of carboplatin or etoposide.'}, 'identificationModule': {'nctId': 'NCT04665856', 'acronym': 'SKYSCRAPER-02C', 'briefTitle': 'Study of Atezolizumab Plus Carboplatin and Etoposide With or Without Tiragolumab in Participants With Untreated Extensive-Stage Small Cell Lung Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Atezolizumab Plus Carboplatin and Etoposide With or Without Tiragolumab in Patients With Untreated Extensive-Stage Small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'YO42373'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tiragolumab + Atezolizumab + Carboplatin and Etoposide', 'description': 'Induction treatment with tiragolumab plus atezolizumab and CE will be administered on a 21-day cycle for 4 cycles. Following the induction phase, participants will continue maintenance therapy with tiragolumab plus atezolizumab for 21-day cycles.', 'interventionNames': ['Drug: Tiragolumab', 'Drug: Atezolizumab', 'Drug: Carboplatin', 'Drug: Etoposide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo + Atezolizumab + Carboplatin and Etoposide', 'description': 'Induction treatment with placebo plus atezolizumab and CE will be administered on a 21-day cycle for 4 cycles. Following the induction phase, participants will continue maintenance therapy with placebo plus atezolizumab for 21-day cycles', 'interventionNames': ['Drug: Atezolizumab', 'Drug: Carboplatin', 'Drug: Etoposide', 'Drug: Tiragolumab Matching Placebo']}], 'interventions': [{'name': 'Tiragolumab', 'type': 'DRUG', 'otherNames': ['MTIG7192A'], 'description': 'Tiragolumab at a fixed dose of 600 milligrams (mg), administered by intravenous (IV) infusion, every 3 weeks (Q3W) on Day 1 of each 21-day cycle.', 'armGroupLabels': ['Tiragolumab + Atezolizumab + Carboplatin and Etoposide']}, {'name': 'Atezolizumab', 'type': 'DRUG', 'otherNames': ['Tecentriq'], 'description': 'Atezolizumab at a fixed dose of 1200 mg, administered by IV infusion, Q3W on Day 1 of each 21-day cycle.', 'armGroupLabels': ['Placebo + Atezolizumab + Carboplatin and Etoposide', 'Tiragolumab + Atezolizumab + Carboplatin and Etoposide']}, {'name': 'Carboplatin', 'type': 'DRUG', 'description': 'Carboplatin administered IV to achieve an initial target area under the concentration time curve (AUC) of 5 mg/mL/min, Q3W on Day 1 of each 21-day cycle for 4 cycles.', 'armGroupLabels': ['Placebo + Atezolizumab + Carboplatin and Etoposide', 'Tiragolumab + Atezolizumab + Carboplatin and Etoposide']}, {'name': 'Etoposide', 'type': 'DRUG', 'description': 'Etoposide 100 mg/m\\^2, administered by IV infusion, Q3W on Day 1, 2 and 3 of each 21-day cycle for 4 cycles.', 'armGroupLabels': ['Placebo + Atezolizumab + Carboplatin and Etoposide', 'Tiragolumab + Atezolizumab + Carboplatin and Etoposide']}, {'name': 'Tiragolumab Matching Placebo', 'type': 'DRUG', 'description': 'Matching placebo, administered by IV infusion, Q3W on Day 1 of each 21-day cycle.', 'armGroupLabels': ['Placebo + Atezolizumab + Carboplatin and Etoposide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100142', 'city': 'Beijing', 'country': 'China', 'facility': 'Beijing Cancer Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '101149', 'city': 'Beijing', 'country': 'China', 'facility': 'Beijing Chest Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '233000', 'city': 'Bengbu', 'country': 'China', 'facility': 'the First Affiliated Hospital of Bengbu Medical College', 'geoPoint': {'lat': 32.94083, 'lon': 117.36083}}, {'zip': '130021', 'city': 'Changchun', 'country': 'China', 'facility': 'the First Hospital of Jilin University', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'zip': '350014', 'city': 'Fuzhou', 'country': 'China', 'facility': 'Fujian Provincial Cancer Hospital', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}, {'zip': '510000', 'city': 'Guangzhou', 'country': 'China', 'facility': 'Cancer Center of Guangzhou Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '310016', 'city': 'Hangzhou', 'country': 'China', 'facility': 'Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '310022', 'city': 'Hangzhou', 'country': 'China', 'facility': 'Zhejiang Cancer Hospital', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '150081', 'city': 'Harbin', 'country': 'China', 'facility': 'Harbin Medical University Cancer Hospital', 'geoPoint': {'lat': 45.75, 'lon': 126.65}}, {'zip': '330006', 'city': 'Nanchang', 'country': 'China', 'facility': 'The 1st Affiliated Hospital of Nanchang Unversity', 'geoPoint': {'lat': 28.68396, 'lon': 115.85306}}, {'zip': '200000', 'city': 'Shanghai', 'country': 'China', 'facility': 'Shanghai Chest Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200032', 'city': 'Shanghai', 'country': 'China', 'facility': 'Zhongshan Hospital Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200120', 'city': 'Shanghai', 'country': 'China', 'facility': 'Fudan University Shanghai Cancer Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '515041', 'city': 'Shantou', 'country': 'China', 'facility': 'Cancer Hospital of Shantou University Medical College', 'geoPoint': {'lat': 23.35489, 'lon': 116.67876}}, {'zip': '430022', 'city': 'Wuhan', 'country': 'China', 'facility': 'Wuhan Union Hospital Tongji Medical College, Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '450008', 'city': 'Zhengzhou', 'country': 'China', 'facility': 'Henan Cancer Hospital', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\\_sharing"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}