Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2026-02-26 @ 4:17 PM
Study NCT ID:
NCT03125902
Status:
COMPLETED
Last Update Posted:
2024-03-26
First Post:
2017-04-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Atezolizumab and Paclitaxel Versus Placebo and Paclitaxel in Participants With Previously Untreated Locally Advanced or Metastatic Triple Negative Breast Cancer (TNBC)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Algeria', 'Egypt', 'Lebanon', 'South Korea'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2020-12-07', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D064726', 'term': 'Triple Negative Breast Neoplasms'}], 'ancestors': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000594389', 'term': 'atezolizumab'}, {'id': 'D017239', 'term': 'Paclitaxel'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, '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': 'From baseline up to 64 months', 'eventGroups': [{'id': 'EG000', 'title': 'Atezolizumab + Paclitaxel', 'description': 'Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.', 'otherNumAtRisk': 431, 'deathsNumAtRisk': 431, 'otherNumAffected': 421, 'seriousNumAtRisk': 431, 'deathsNumAffected': 229, 'seriousNumAffected': 112}, {'id': 'EG001', 'title': 'Placebo + Paclitaxel', 'description': 'Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.', 'otherNumAtRisk': 220, 'deathsNumAtRisk': 220, 'otherNumAffected': 209, 'seriousNumAtRisk': 220, 'deathsNumAffected': 119, 'seriousNumAffected': 40}], 'otherEvents': [{'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 277, 'numAffected': 128}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 134, 'numAffected': 66}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'LEUKOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 181, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 44, 'numAffected': 20}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'NEUTROPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 253, 'numAffected': 98}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 103, 'numAffected': 48}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'HYPERTHYROIDISM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 28, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'HYPOTHYROIDISM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 65, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 45, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 21, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'ABDOMINAL PAIN UPPER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 47, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 22, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'CONSTIPATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 103, 'numAffected': 82}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 56, 'numAffected': 33}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 209, 'numAffected': 130}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 88, 'numAffected': 50}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'DRY MOUTH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 32, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'DYSPEPSIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 18, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 167, 'numAffected': 117}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 108, 'numAffected': 54}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'STOMATITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 29, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 18, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 110, 'numAffected': 70}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 36, 'numAffected': 20}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'ASTHENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 149, 'numAffected': 101}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 61, 'numAffected': 47}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 154, 'numAffected': 119}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 73, 'numAffected': 57}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'OEDEMA PERIPHERAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 66, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 29, 'numAffected': 22}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'PYREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 92, 'numAffected': 68}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 39, 'numAffected': 25}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 41, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 19, 'numAffected': 16}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'UPPER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 45, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 22, 'numAffected': 18}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 48, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 15, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'ALANINE AMINOTRANSFERASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 168, 'numAffected': 86}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 62, 'numAffected': 38}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'ASPARTATE AMINOTRANSFERASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 165, 'numAffected': 87}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 68, 'numAffected': 39}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'NEUTROPHIL COUNT DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 361, 'numAffected': 68}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 220, 'numAffected': 35}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'WEIGHT DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 35, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'WHITE BLOOD CELL COUNT DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 285, 'numAffected': 65}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 203, 'numAffected': 30}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'DECREASED APPETITE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 106, 'numAffected': 66}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 33, 'numAffected': 22}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'ARTHRALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 96, 'numAffected': 69}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 25, 'numAffected': 21}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 51, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 23, 'numAffected': 20}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'MYALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 59, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 34, 'numAffected': 25}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'PAIN IN EXTREMITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 61, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 34, 'numAffected': 23}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'DIZZINESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 43, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 23, 'numAffected': 20}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'DYSGEUSIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 39, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 19, 'numAffected': 16}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 76, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 44, 'numAffected': 38}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'HYPOAESTHESIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 37, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 20, 'numAffected': 16}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'NEUROPATHY PERIPHERAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 173, 'numAffected': 126}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 83, 'numAffected': 60}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'PARAESTHESIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 52, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 30, 'numAffected': 22}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'PERIPHERAL SENSORY NEUROPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 52, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 26, 'numAffected': 23}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'INSOMNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 40, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 22, 'numAffected': 22}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'BREAST PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 34, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 109, 'numAffected': 86}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 44, 'numAffected': 37}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'DYSPNOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 57, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 29, 'numAffected': 24}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'EPISTAXIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 30, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 18, 'numAffected': 15}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'ALOPECIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 257, 'numAffected': 253}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 124, 'numAffected': 118}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'ERYTHEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 29, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'PRURITUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 74, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 22, 'numAffected': 19}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'RASH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 108, 'numAffected': 78}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 51, 'numAffected': 36}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'HOT FLUSH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 21, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'HYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 35, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'HYPERGLYCAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 41, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 21, 'numAffected': 9}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'HYPOKALAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 32, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 16, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}], 'seriousEvents': [{'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'BICYTOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'FEBRILE NEUTROPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'LYMPHADENITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'NEUTROPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'THROMBOCYTOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'CARDIAC FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'PERICARDITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'VERTIGO', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'HYPOPHYSITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'HYPOTHYROIDISM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 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'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'HYPERAMYLASAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'HYPERLIPASAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'HYPOCALCAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 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[{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'PAIN IN EXTREMITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'PATHOLOGICAL FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'POLYMYOSITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'TUMOUR PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'CEREBRAL VENOUS SINUS THROMBOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'COGNITIVE DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'DIZZINESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'EPILEPSY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'MYASTHENIA GRAVIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'SCIATICA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'SEIZURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'DEVICE BREAKAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'DEVICE KINK', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'DEPRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'ACUTE KIDNEY INJURY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'GLOMERULONEPHRITIS CHRONIC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'NEPHRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'RENAL IMPAIRMENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'CHRONIC OBSTRUCTIVE PULMONARY DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'DYSPNOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'EPISTAXIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'HAEMOPTYSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'INTERSTITIAL LUNG DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'LUNG DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'PLEURAL EFFUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'PNEUMONITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'PULMONARY EMBOLISM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'RESPIRATORY DISTRESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'DEEP VEIN THROMBOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'HAEMATOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'HYPERTENSIVE CRISIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'HYPOTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'THROMBOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'MYELOSUPPRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'VENTRICULAR ARRHYTHMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'AUTOIMMUNE PANCREATITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'GENERAL PHYSICAL HEALTH DETERIORATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'SEPTIC SHOCK', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'FALL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'FIBULA FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'SKIN LACERATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'NEUTROPHIL COUNT DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'WHITE BLOOD CELL COUNT DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'BONE PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'CEREBRAL INFARCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'SYNCOPE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'COMPLETED SUICIDE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'HYPOMANIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'EMBOLISM VENOUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 431, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression-Free Survival (PFS) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in the Subpopulation With Programmed Death-Ligand 1 (PD-L1)-Positive Tumour Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo and Paclitaxel', 'description': 'Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Atezolizumab and Paclitaxel', 'description': 'Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.72', 'groupId': 'OG000', 'lowerLimit': '5.39', 'upperLimit': '7.20'}, {'value': '5.95', 'groupId': 'OG001', 'lowerLimit': '5.62', 'upperLimit': '7.43'}]}]}], 'analyses': [{'pValue': '0.2032', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.82', 'ciLowerLimit': '0.60', 'ciUpperLimit': '1.12', 'groupDescription': 'Stratified Analysis', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2601', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.84', 'ciLowerLimit': '0.62', 'ciUpperLimit': '1.14', 'groupDescription': 'Unstratified Analysis', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From Day 1 to disease progression (PD) or death from any cause, assessed up to primary completion date (approximately 26 months)', 'description': 'PFS is defined as the time from randomization to the first occurrence of PD, as determined by the investigator using RECIST v1.1, or death from any cause during the study, whichever occurs first. PD is defined as greater than or equal to (\\>/=) 20 percent (%) relative increase and \\>/=5 millimeter (mm) of absolute increase in the sum of diameters (SD) of target lesions (TLs), taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'PD-L1-positive subpopulation: participants in the ITT population whose PD-L1 status was IC1/2/3 at the time of randomization'}, {'type': 'PRIMARY', 'title': 'Progression-Free Survival (PFS) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in the Intent-to-Treat (ITT) Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}, {'value': '431', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo and Paclitaxel', 'description': 'Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Atezolizumab and Paclitaxel', 'description': 'Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.55', 'groupId': 'OG000', 'lowerLimit': '5.36', 'upperLimit': '6.51'}, {'value': '5.68', 'groupId': 'OG001', 'lowerLimit': '5.42', 'upperLimit': '7.16'}]}]}], 'analyses': [{'pValue': '0.1343', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.86', 'ciLowerLimit': '0.70', 'ciUpperLimit': '1.05', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Stratified Analysis'}, {'pValue': '0.1285', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.86', 'ciLowerLimit': '0.70', 'ciUpperLimit': '1.05', 'groupDescription': 'Unstratified Analysis', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From Day 1 to disease progression (PD) or death from any cause, assessed up to primary completion date (approximately 26 months)', 'description': 'PFS is defined as the time from randomization to the first occurrence of PD, as determined by the investigator using RECIST v1.1, or death from any cause during the study, whichever occurs first. PD is defined as greater than or equal to (\\>/=) 20 percent (%) relative increase and \\>/=5 millimeter (mm) of absolute increase in the sum of diameters (SD) of target lesions (TLs), taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population: all randomized participants, whether or not the assigned study treatment was received'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS) in the PD-L1-Positive Subpopulation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo and Paclitaxel', 'description': 'Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Atezolizumab and Paclitaxel', 'description': 'Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '28.29', 'comment': 'Upper limit not determined due to insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': '19.06', 'upperLimit': 'NA'}, {'value': '22.05', 'groupId': 'OG001', 'lowerLimit': '19.19', 'upperLimit': '30.52'}]}]}], 'analyses': [{'pValue': '0.5798', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.11', 'ciLowerLimit': '0.76', 'ciUpperLimit': '1.64', 'groupDescription': 'Stratified Analysis', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4035', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.18', 'ciLowerLimit': '0.80', 'ciUpperLimit': '1.72', 'groupDescription': 'Unstratified Analysis', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From Day 1 to death from any cause, assessed up 36 months', 'description': 'OS is defined as the time from randomization to death from any cause. Results from a pre-specified interim analysis.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'PD-L1-positive subpopulation: participants in the ITT population whose PD-L1 status was IC1/2/3 at the time of randomization'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS) in the ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}, {'value': '431', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo and Paclitaxel', 'description': 'Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Atezolizumab and Paclitaxel', 'description': 'Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.80', 'groupId': 'OG000', 'lowerLimit': '17.08', 'upperLimit': '28.29'}, {'value': '19.19', 'groupId': 'OG001', 'lowerLimit': '16.59', 'upperLimit': '22.05'}]}]}], 'analyses': [{'pValue': '0.3425', 'groupIds': ['OG000'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.12', 'ciLowerLimit': '0.88', 'ciUpperLimit': '1.43', 'groupDescription': 'Stratified analysis', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2166', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.16', 'ciLowerLimit': '0.92', 'ciUpperLimit': '1.48', 'groupDescription': 'Unstratified Analysis', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From Day 1 to death from any cause, assessed up to end of study (up to approximately 36 months)', 'description': 'OS is defined as the time from randomization to death from any cause. Results from a pre-specified interim analysis.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population: all randomized participants, whether or not the assigned study treatment was received'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Are Alive at 12 and 18 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}, {'value': '431', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo and Paclitaxel', 'description': 'Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Atezolizumab and Paclitaxel', 'description': 'Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.'}], 'classes': [{'title': '12 months', 'categories': [{'measurements': [{'value': '73.47', 'groupId': 'OG000', 'lowerLimit': '67.44', 'upperLimit': '79.49'}, {'value': '68.86', 'groupId': 'OG001', 'lowerLimit': '64.37', 'upperLimit': '73.34'}]}]}, {'title': '18 months', 'categories': [{'measurements': [{'value': '56.18', 'groupId': 'OG000', 'lowerLimit': '48.94', 'upperLimit': '63.42'}, {'value': '52.32', 'groupId': 'OG001', 'lowerLimit': '47.15', 'upperLimit': '57.48'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 1 to death from any cause, assessed up to 12 and 18 months', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population: all randomized participants, whether or not the assigned study treatment was received'}, {'type': 'SECONDARY', 'title': 'Time to Deterioration (TTD) in Global Health Status/ Health Related Quality of Life (HRQoL) in the PRO Evaluable Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '205', 'groupId': 'OG000'}, {'value': '384', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo and Paclitaxel', 'description': 'Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Atezolizumab and Paclitaxel', 'description': 'Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.35', 'comment': 'Upper limit was not reached due to not sufficient number of participants with event.', 'groupId': 'OG000', 'lowerLimit': '9.23', 'upperLimit': 'NA'}, {'value': '28.68', 'comment': 'Upper limit was not reached due to not sufficient number of participants with event.', 'groupId': 'OG001', 'lowerLimit': '11.99', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.6465', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.94', 'ciLowerLimit': '0.71', 'ciUpperLimit': '1.24', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Stratified analysis'}], 'paramType': 'MEDIAN', 'timeFrame': 'From Day 1 to deterioration, assessed up 64 months', 'description': 'Deterioration in Global Health Status/HRQoL is defined as a decrease of at least 10 points on the Global Health Status /HRQoL scale (comprised of 2 items: 29 and 30) of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). The 2 items use 7-point scale (1 = very poor to 7 = Excellent). Scores are averaged, transformed to 0-100 scale; where higher score=better level of functioning or greater degree of symptoms.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'PRO-evaluable populations: participants in the ITT population with baseline PRO assessment and at least one post-baseline PRO assessment in the questionnaire of interest (European Organization for the Research and Treatment of Cancer \\[EORTC\\] Quality-of-life Questionnaire \\[QLQ\\] C30, EORTC QLQ BR-23 or FACT-G)'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Are Alive Without Progression Event at Month 12 Assessed Using RECIST v1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}, {'value': '431', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo and Paclitaxel', 'description': 'Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Atezolizumab and Paclitaxel', 'description': 'Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.22', 'groupId': 'OG000', 'lowerLimit': '10.18', 'upperLimit': '22.26'}, {'value': '21.63', 'groupId': 'OG001', 'lowerLimit': '16.74', 'upperLimit': '26.51'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 1 to PD or death from any cause, assessed up to 12 months', 'description': 'PD is defined as \\>/=20% relative increase and \\>/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population: all randomized participants, whether or not the assigned study treatment was received'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Objective Response Assessed Using RECIST v1.1 in the PD-L1-Positive Population (Confirmed, Investigator-Assessed )', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo and Paclitaxel', 'description': 'Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Atezolizumab and Paclitaxel', 'description': 'Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '40.6', 'groupId': 'OG000', 'lowerLimit': '30.93', 'upperLimit': '50.82'}, {'value': '49.2', 'groupId': 'OG001', 'lowerLimit': '41.92', 'upperLimit': '56.53'}]}]}], 'analyses': [{'pValue': '0.1526', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.44', 'ciLowerLimit': '0.87', 'ciUpperLimit': '2.37', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 1 to PD, assessed up to primary completion date (approximately 26 months)', 'description': 'Objective response is defined as complete response (CR) or partial response (PR), as determined by the investigator using RECIST v1.1 criteria. CR is defined as the disappearance of all TLs and SA reduction to less than (\\<) 10mm for nodal TLs/ non-TLs. PR is defined as \\>/=30% decrease in SD of TLs, taking as reference the baseline SD. Responses were confirmed after 8 weeks if within first 12 months or after 12 weeks if later.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'PD-L1-positive subpopulation: participants in the ITT population whose PD-L1 status was IC1/2/3 at the time of randomization'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Objective Response Assessed Using RECIST v1.1 in the PD-L1-Positive Population (Unconfirmed, Investigator-Assessed)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo and Paclitaxel', 'description': 'Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Atezolizumab and Paclitaxel', 'description': 'Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '55.4', 'groupId': 'OG000', 'lowerLimit': '45.22', 'upperLimit': '65.34'}, {'value': '63.4', 'groupId': 'OG001', 'lowerLimit': '56.09', 'upperLimit': '70.19'}]}]}], 'analyses': [{'pValue': '0.1834', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.40', 'ciLowerLimit': '0.85', 'ciUpperLimit': '2.31', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 1 to PD, assessed up to primary completion date (approximately 26 months)', 'description': 'Objective response is defined as complete response (CR) or partial response (PR), as determined by the investigator using RECIST v1.1 criteria. CR is defined as the disappearance of all TLs and SA reduction to less than (\\<) 10mm for nodal TLs/ non-TLs. PR is defined as \\>/=30% decrease in SD of TLs, taking as reference the baseline SD.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'PD-L1-positive subpopulation: participants in the ITT population whose PD-L1 status was IC1/2/3 at the time of randomization'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Objective Response Assessed Using RECIST v1.1 in the Response-Evaluable Population (Confirmed, Investigator-Assessed )', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '431', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo and Paclitaxel', 'description': 'Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Atezolizumab and Paclitaxel', 'description': 'Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '32.4', 'groupId': 'OG000', 'lowerLimit': '26.27', 'upperLimit': '39.05'}, {'value': '39.9', 'groupId': 'OG001', 'lowerLimit': '35.25', 'upperLimit': '44.70'}]}]}], 'analyses': [{'pValue': '0.0513', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.42', 'ciLowerLimit': '1.00', 'ciUpperLimit': '2.02', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 1 to PD, assessed up to primary completion date (approximately 26 months)', 'description': 'Objective response is defined as complete response (CR) or partial response (PR), as determined by the investigator using RECIST v1.1 criteria. CR is defined as the disappearance of all TLs and SA reduction to less than (\\<) 10mm for nodal TLs/ non-TLs. PR is defined as \\>/=30% decrease in SD of TLs, taking as reference the baseline SD. Responses were confirmed after 8 weeks if within first 12 months or after 12 weeks if later.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Response-evaluable population: participants in the ITT population with measurable disease at baseline'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Objective Response Assessed Using RECIST v1.1 in the Response-Evaluable Population (Unconfirmed, Investigator-Assessed )', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '431', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo and Paclitaxel', 'description': 'Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Atezolizumab and Paclitaxel', 'description': 'Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '47.5', 'groupId': 'OG000', 'lowerLimit': '40.72', 'upperLimit': '54.33'}, {'value': '53.6', 'groupId': 'OG001', 'lowerLimit': '48.76', 'upperLimit': '58.38'}]}]}], 'analyses': [{'pValue': '0.1226', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.30', 'ciLowerLimit': '0.93', 'ciUpperLimit': '1.81', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 1 to PD, assessed up to primary completion date (approximately 26 months)', 'description': 'Objective response is defined as complete response (CR) or partial response (PR), as determined by the investigator using RECIST v1.1 criteria. CR is defined as the disappearance of all TLs and SA reduction to less than (\\<) 10mm for nodal TLs/ non-TLs. PR is defined as \\>/=30% decrease in SD of TLs, taking as reference the baseline SD.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Response-evaluable population: participants in the ITT population with measurable disease at baseline'}, {'type': 'SECONDARY', 'title': 'Duration of Objective Response (DOR) Assessed Using RECIST v1.1 in DOR-evaluable Population (Unconfirmed)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo and Paclitaxel', 'description': 'Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Atezolizumab and Paclitaxel', 'description': 'Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.45', 'groupId': 'OG000', 'lowerLimit': '4.67', 'upperLimit': '6.31'}, {'value': '6.41', 'groupId': 'OG001', 'lowerLimit': '5.55', 'upperLimit': '7.39'}]}]}], 'analyses': [{'pValue': '0.0641', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.74', 'ciLowerLimit': '0.54', 'ciUpperLimit': '1.02', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Unstratified Analysis'}], 'paramType': 'MEDIAN', 'timeFrame': 'From objective response to PD, assessed up to primary completion date (approximately 26 months)', 'description': 'DOR is defined as the time period from the date of initial CR or PR until the date of PD or death from any cause, whichever occurs first. CR is defined as the disappearance of all TLs and SA reduction to \\<10mm for nodal TLs/ non-TLs. PR is defined as \\>/=30% decrease in SD of TLs, taking as reference the baseline SD. PD is defined as \\>/=20% relative increase and \\>/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Duration of response (DoR)-evaluable population: participants in the ITT population with measurable disease at baseline'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Clinical Benefit Assessed Using RECIST v1.1 in Response-evaluable Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '431', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo and Paclitaxel', 'description': 'Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Atezolizumab and Paclitaxel', 'description': 'Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '49.8', 'groupId': 'OG000', 'lowerLimit': '42.96', 'upperLimit': '56.59'}, {'value': '57.1', 'groupId': 'OG001', 'lowerLimit': '52.25', 'upperLimit': '61.80'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 1 to PD, assessed up to primary completion date (approximately 26 months)', 'description': 'Clinical benefit is defined as the achievement of CR, PR, or stable disease according to RECIST v1.1 that lasts for at least 6 months. CR is defined as the disappearance of all TLs and SA reduction to \\<10mm for nodal TLs/ non-TLs. PR is defined as \\>/=30% decrease in SD of TLs, taking as reference the baseline SD. PD is defined as \\>/=20% relative increase and \\>/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions. Stable disease is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference smallest SD since treatment started.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Clinical Benefit Rate analysis included all participants with unconfirmed PR/CR or SD of at least 6 months duration'}, {'type': 'SECONDARY', 'title': 'Minimum Observed Serum Concentration (Cmin) of Atezolizumab in PK Evaluable Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '342', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Atezolizumab and Paclitaxel', 'description': 'Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.'}], 'classes': [{'title': 'C2D1 predose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '316', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '139', 'spread': '53.3', 'groupId': 'OG000'}]}]}, {'title': 'C3D1 predose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '208', 'spread': '78.3', 'groupId': 'OG000'}]}]}, {'title': 'C4D1 predose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '242', 'spread': '84.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose (0 hours) on Day 1 of Cycles 2-4 and at treatment discontinuation (TD), (approximately 9 months).', 'unitOfMeasure': 'μg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK-evaluable population: all participants who received any dose of Atezolizumab and who have at least one evaluable post-baseline PK sample. For all safety, PK and immunogenicity analyses, participants were grouped according to the treatment actually received, including cases in which atezolizumab was received in error.'}, {'type': 'SECONDARY', 'title': 'Maximum Observed Serum Concentration (Cmax) of Atezolizumab in PK-evaluable Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '308', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Atezolizumab and Paclitaxel', 'description': 'Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '321', 'spread': '90.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'C1D1 30 min postdose', 'unitOfMeasure': 'μg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK-evaluable population: all participants who received any dose of Atezolizumab and who have at least one evaluable post-baseline PK sample. For all safety, PK and immunogenicity analyses, participants were grouped according to the treatment actually received, including cases in which atezolizumab was received in error.'}, {'type': 'SECONDARY', 'title': 'Minimum Observed Plasma Concentration (Cmin) of Paclitaxel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo and Paclitaxel', 'description': 'Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Atezolizumab and Paclitaxel', 'description': 'Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.51', 'spread': 'NA', 'comment': 'Insufficient number of samples analyzed.', 'groupId': 'OG000'}, {'value': '1.67', 'spread': 'NA', 'comment': 'Insufficient number of samples analyzed.', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose (0 hours) on Day 1 of Cycle 3 (1 Cycle = 28 days)', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK-evaluable population: first 60 participants who received any dose of Paclitaxel and who have at least one evaluable post-baseline PK sample. For all safety, PK and immunogenicity analyses, participants were grouped according to the treatment actually received, including cases in which atezolizumab was received in error.'}, {'type': 'SECONDARY', 'title': 'Maximum Observed Plasma Concentration (Cmax) of Paclitaxel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo and Paclitaxel', 'description': 'Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Atezolizumab and Paclitaxel', 'description': 'Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.'}], 'classes': [{'title': 'C1D1 Post-Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '518', 'spread': '290.7', 'groupId': 'OG000'}, {'value': '301', 'spread': '1501', 'groupId': 'OG001'}]}]}, {'title': 'C3D1 Post-Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '666', 'spread': '339', 'groupId': 'OG000'}, {'value': '276', 'spread': '1360', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose (0 hours), 5-10 min before and after paclitaxel infusion, 60 min after paclitaxel infusion on Day 1 of Cycles 1 and 3 (paclitaxel infusion duration= 60 min) (1 Cycle = 28 days)', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK-evaluable population: first 60 participants who received any dose of Paclitaxel and who have at least one evaluable post-baseline PK sample. For all safety, PK and immunogenicity analyses, participants were grouped according to the treatment actually received, including cases in which atezolizumab was received in error.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}, {'value': '432', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo and Paclitaxel', 'description': 'Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Atezolizumab and Paclitaxel', 'description': 'Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.'}], 'classes': [{'title': 'Percentage of participants with at least one AE', 'categories': [{'measurements': [{'value': '97.7', 'groupId': 'OG000'}, {'value': '99.1', 'groupId': 'OG001'}]}]}, {'title': 'Percentage of participants with at least one SAE', 'categories': [{'measurements': [{'value': '18.4', 'groupId': 'OG000'}, {'value': '25.9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Day 1 From baseline up to 64 months', 'description': 'Investigator text for AEs is coded using MedDRA version 25.1', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety-evaluable population: participants who received any amount of any study drug. For all safety, PK and immunogenicity analyses, participants were grouped according to the treatment actually received, including cases in which atezolizumab was received in error.'}, {'type': 'SECONDARY', 'title': "Percentage of Participants With Anti-Drug Antibodies' (ADAs) Against Atezolizumab in ADA Evaluable Population", 'denoms': [{'units': 'Participants', 'counts': [{'value': '334', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Atezolizumab and Paclitaxel', 'description': 'Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.'}], 'classes': [{'title': 'Percentage of participants positive for ADA at Baseline', 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000'}]}]}, {'title': 'Percentage of participants positive for ADA Post-baseline', 'categories': [{'measurements': [{'value': '14.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Pre-dose (0 hours) on Day 1 of Cycles 1, 2, 3, 4, 8, 12, 16, and at every 8 cycles thereafter until TD, at TD, and at 90-150 days after TD (maximum up to 45 months) (1 Cycle = 28 days)', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Anti-Drug Antibody (ADA) population:\n\n* Baseline ADA-evaluable population: all participants with at least one evaluable ADA assay result from a baseline sample\n* Post baseline ADA-Evaluable population: all participants with at least one evaluable ADA assay result from at least one post-baseline sample.\n\nFor all safety, PK and immunogenicity analyses, participants were grouped according to the treatment actually received, including cases in which atezolizumab was received in error.'}, {'type': 'SECONDARY', 'title': 'Overall Survival by PD-L1 Status, Intent to Treat Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}, {'value': '431', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo and Paclitaxel', 'description': 'Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Atezolizumab and Paclitaxel', 'description': 'Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.'}], 'classes': [{'title': 'PD-L1 IC0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '240', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.30', 'groupId': 'OG000', 'lowerLimit': '14.72', 'upperLimit': '25.10'}, {'value': '16.30', 'groupId': 'OG001', 'lowerLimit': '14.52', 'upperLimit': '19.65'}]}]}, {'title': 'PD-L1 IC1/2/3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28.29', 'comment': 'Upper limit not determined due to insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': '19.06', 'upperLimit': 'NA'}, {'value': '22.05', 'groupId': 'OG001', 'lowerLimit': '19.19', 'upperLimit': '30.52'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From Day 1 up to 66 months', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population: all randomized participants, whether or not the assigned study treatment was received'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival by PD-L1 Status, Intent to Treat Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}, {'value': '431', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo and Paclitaxel', 'description': 'Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Atezolizumab and Paclitaxel', 'description': 'Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.'}], 'classes': [{'title': 'PD-L1 IC0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '240', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.49', 'groupId': 'OG000', 'lowerLimit': '3.84', 'upperLimit': '6.51'}, {'value': '5.45', 'groupId': 'OG001', 'lowerLimit': '4.60', 'upperLimit': '6.51'}]}]}, {'title': 'PD-L1 IC1/2/3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.72', 'groupId': 'OG000', 'lowerLimit': '5.39', 'upperLimit': '7.20'}, {'value': '5.95', 'groupId': 'OG001', 'lowerLimit': '5.62', 'upperLimit': '7.43'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From Day 1 up to primary completion date (approximately 26 months)', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population: all randomized participants, whether or not the assigned study treatment was received'}, {'type': 'SECONDARY', 'title': 'Duration of Confirmed Response (C-DoR) in (C-DoR)-Evaluable Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo and Paclitaxel', 'description': 'Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.'}, {'id': 'OG001', 'title': 'Atezolizumab and Paclitaxel', 'description': 'Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.75', 'groupId': 'OG000', 'lowerLimit': '5.36', 'upperLimit': '7.56'}, {'value': '7.66', 'groupId': 'OG001', 'lowerLimit': '7.16', 'upperLimit': '11.33'}]}]}], 'analyses': [{'pValue': '0.01227', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.62', 'ciLowerLimit': '0.42', 'ciUpperLimit': '0.90', 'groupDescription': 'Unstratified Analysis', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From objective response to PD, assessed up to primary completion date (approximately 26 months)', 'description': 'C-DoR is defined as the time from the first occurrence of a documented confirmed response (CR or PR) in C-DOR evaluable population until the date of disease progression per RECIST v1.1 or death from any cause, whichever occurs first. Responses were confirmed after 8 weeks if within first 12 months or after 12 weeks if later.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Duration of confirmed response (C-DoR)-evaluable population: participants in the ITT population with measurable disease at baseline and with a confirmed objective response'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo + Paclitaxel', 'description': 'Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.'}, {'id': 'FG001', 'title': 'Atezolizumab + Paclitaxel', 'description': 'Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '220'}, {'groupId': 'FG001', 'numSubjects': '431'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '220'}, {'groupId': 'FG001', 'numSubjects': '431'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '119'}, {'groupId': 'FG001', 'numSubjects': '229'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Progressive Disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Study Terminated By Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '74'}, {'groupId': 'FG001', 'numSubjects': '143'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '37'}]}]}], 'preAssignmentDetails': 'The target population included subjects with previously untreated inoperable locally advanced or metastatic TNBC.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'BG000'}, {'value': '431', 'groupId': 'BG001'}, {'value': '651', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo and Paclitaxel', 'description': 'Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.'}, {'id': 'BG001', 'title': 'Atezolizumab and Paclitaxel', 'description': 'Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '176', 'groupId': 'BG000'}, {'value': '322', 'groupId': 'BG001'}, {'value': '498', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '109', 'groupId': 'BG001'}, {'value': '153', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.7', 'spread': '12.2', 'groupId': 'BG000'}, {'value': '54.8', 'spread': '12.6', 'groupId': 'BG001'}, {'value': '54.0', 'spread': '12.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '220', 'groupId': 'BG000'}, {'value': '430', 'groupId': 'BG001'}, {'value': '650', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '174', 'groupId': 'BG000'}, {'value': '332', 'groupId': 'BG001'}, {'value': '506', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '78', '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': '66', 'groupId': 'BG000'}, {'value': '123', 'groupId': 'BG001'}, {'value': '189', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '128', 'groupId': 'BG000'}, {'value': '246', 'groupId': 'BG001'}, {'value': '374', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-02-11', 'size': 5113443, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-11-10T12:03', 'hasProtocol': True}, {'date': '2020-03-25', 'size': 1555871, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-11-10T12:03', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'The Sponsor and its agents; the study site personnel, including the investigator; and the participant will be blinded to treatment assignment.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 653}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2023-01-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-01', 'studyFirstSubmitDate': '2017-04-20', 'resultsFirstSubmitDate': '2020-11-10', 'studyFirstSubmitQcDate': '2017-04-20', 'lastUpdatePostDateStruct': {'date': '2024-03-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-12-09', 'studyFirstPostDateStruct': {'date': '2017-04-24', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-01-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-Free Survival (PFS) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in the Subpopulation With Programmed Death-Ligand 1 (PD-L1)-Positive Tumour Status', 'timeFrame': 'From Day 1 to disease progression (PD) or death from any cause, assessed up to primary completion date (approximately 26 months)', 'description': 'PFS is defined as the time from randomization to the first occurrence of PD, as determined by the investigator using RECIST v1.1, or death from any cause during the study, whichever occurs first. PD is defined as greater than or equal to (\\>/=) 20 percent (%) relative increase and \\>/=5 millimeter (mm) of absolute increase in the sum of diameters (SD) of target lesions (TLs), taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions.'}, {'measure': 'Progression-Free Survival (PFS) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in the Intent-to-Treat (ITT) Population', 'timeFrame': 'From Day 1 to disease progression (PD) or death from any cause, assessed up to primary completion date (approximately 26 months)', 'description': 'PFS is defined as the time from randomization to the first occurrence of PD, as determined by the investigator using RECIST v1.1, or death from any cause during the study, whichever occurs first. PD is defined as greater than or equal to (\\>/=) 20 percent (%) relative increase and \\>/=5 millimeter (mm) of absolute increase in the sum of diameters (SD) of target lesions (TLs), taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS) in the PD-L1-Positive Subpopulation', 'timeFrame': 'From Day 1 to death from any cause, assessed up 36 months', 'description': 'OS is defined as the time from randomization to death from any cause. Results from a pre-specified interim analysis.'}, {'measure': 'Overall Survival (OS) in the ITT Population', 'timeFrame': 'From Day 1 to death from any cause, assessed up to end of study (up to approximately 36 months)', 'description': 'OS is defined as the time from randomization to death from any cause. Results from a pre-specified interim analysis.'}, {'measure': 'Percentage of Participants Who Are Alive at 12 and 18 Months', 'timeFrame': 'From Day 1 to death from any cause, assessed up to 12 and 18 months'}, {'measure': 'Time to Deterioration (TTD) in Global Health Status/ Health Related Quality of Life (HRQoL) in the PRO Evaluable Population', 'timeFrame': 'From Day 1 to deterioration, assessed up 64 months', 'description': 'Deterioration in Global Health Status/HRQoL is defined as a decrease of at least 10 points on the Global Health Status /HRQoL scale (comprised of 2 items: 29 and 30) of the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). The 2 items use 7-point scale (1 = very poor to 7 = Excellent). Scores are averaged, transformed to 0-100 scale; where higher score=better level of functioning or greater degree of symptoms.'}, {'measure': 'Percentage of Participants Who Are Alive Without Progression Event at Month 12 Assessed Using RECIST v1.1', 'timeFrame': 'From Day 1 to PD or death from any cause, assessed up to 12 months', 'description': 'PD is defined as \\>/=20% relative increase and \\>/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions.'}, {'measure': 'Percentage of Participants With Objective Response Assessed Using RECIST v1.1 in the PD-L1-Positive Population (Confirmed, Investigator-Assessed )', 'timeFrame': 'From Day 1 to PD, assessed up to primary completion date (approximately 26 months)', 'description': 'Objective response is defined as complete response (CR) or partial response (PR), as determined by the investigator using RECIST v1.1 criteria. CR is defined as the disappearance of all TLs and SA reduction to less than (\\<) 10mm for nodal TLs/ non-TLs. PR is defined as \\>/=30% decrease in SD of TLs, taking as reference the baseline SD. Responses were confirmed after 8 weeks if within first 12 months or after 12 weeks if later.'}, {'measure': 'Percentage of Participants With Objective Response Assessed Using RECIST v1.1 in the PD-L1-Positive Population (Unconfirmed, Investigator-Assessed)', 'timeFrame': 'From Day 1 to PD, assessed up to primary completion date (approximately 26 months)', 'description': 'Objective response is defined as complete response (CR) or partial response (PR), as determined by the investigator using RECIST v1.1 criteria. CR is defined as the disappearance of all TLs and SA reduction to less than (\\<) 10mm for nodal TLs/ non-TLs. PR is defined as \\>/=30% decrease in SD of TLs, taking as reference the baseline SD.'}, {'measure': 'Percentage of Participants With Objective Response Assessed Using RECIST v1.1 in the Response-Evaluable Population (Confirmed, Investigator-Assessed )', 'timeFrame': 'From Day 1 to PD, assessed up to primary completion date (approximately 26 months)', 'description': 'Objective response is defined as complete response (CR) or partial response (PR), as determined by the investigator using RECIST v1.1 criteria. CR is defined as the disappearance of all TLs and SA reduction to less than (\\<) 10mm for nodal TLs/ non-TLs. PR is defined as \\>/=30% decrease in SD of TLs, taking as reference the baseline SD. Responses were confirmed after 8 weeks if within first 12 months or after 12 weeks if later.'}, {'measure': 'Percentage of Participants With Objective Response Assessed Using RECIST v1.1 in the Response-Evaluable Population (Unconfirmed, Investigator-Assessed )', 'timeFrame': 'From Day 1 to PD, assessed up to primary completion date (approximately 26 months)', 'description': 'Objective response is defined as complete response (CR) or partial response (PR), as determined by the investigator using RECIST v1.1 criteria. CR is defined as the disappearance of all TLs and SA reduction to less than (\\<) 10mm for nodal TLs/ non-TLs. PR is defined as \\>/=30% decrease in SD of TLs, taking as reference the baseline SD.'}, {'measure': 'Duration of Objective Response (DOR) Assessed Using RECIST v1.1 in DOR-evaluable Population (Unconfirmed)', 'timeFrame': 'From objective response to PD, assessed up to primary completion date (approximately 26 months)', 'description': 'DOR is defined as the time period from the date of initial CR or PR until the date of PD or death from any cause, whichever occurs first. CR is defined as the disappearance of all TLs and SA reduction to \\<10mm for nodal TLs/ non-TLs. PR is defined as \\>/=30% decrease in SD of TLs, taking as reference the baseline SD. PD is defined as \\>/=20% relative increase and \\>/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions.'}, {'measure': 'Percentage of Participants With Clinical Benefit Assessed Using RECIST v1.1 in Response-evaluable Population', 'timeFrame': 'From Day 1 to PD, assessed up to primary completion date (approximately 26 months)', 'description': 'Clinical benefit is defined as the achievement of CR, PR, or stable disease according to RECIST v1.1 that lasts for at least 6 months. CR is defined as the disappearance of all TLs and SA reduction to \\<10mm for nodal TLs/ non-TLs. PR is defined as \\>/=30% decrease in SD of TLs, taking as reference the baseline SD. PD is defined as \\>/=20% relative increase and \\>/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions. Stable disease is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference smallest SD since treatment started.'}, {'measure': 'Minimum Observed Serum Concentration (Cmin) of Atezolizumab in PK Evaluable Population', 'timeFrame': 'Pre-dose (0 hours) on Day 1 of Cycles 2-4 and at treatment discontinuation (TD), (approximately 9 months).'}, {'measure': 'Maximum Observed Serum Concentration (Cmax) of Atezolizumab in PK-evaluable Population', 'timeFrame': 'C1D1 30 min postdose'}, {'measure': 'Minimum Observed Plasma Concentration (Cmin) of Paclitaxel', 'timeFrame': 'Pre-dose (0 hours) on Day 1 of Cycle 3 (1 Cycle = 28 days)'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax) of Paclitaxel', 'timeFrame': 'Pre-dose (0 hours), 5-10 min before and after paclitaxel infusion, 60 min after paclitaxel infusion on Day 1 of Cycles 1 and 3 (paclitaxel infusion duration= 60 min) (1 Cycle = 28 days)'}, {'measure': 'Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs)', 'timeFrame': 'From Day 1 From baseline up to 64 months', 'description': 'Investigator text for AEs is coded using MedDRA version 25.1'}, {'measure': "Percentage of Participants With Anti-Drug Antibodies' (ADAs) Against Atezolizumab in ADA Evaluable Population", 'timeFrame': 'Pre-dose (0 hours) on Day 1 of Cycles 1, 2, 3, 4, 8, 12, 16, and at every 8 cycles thereafter until TD, at TD, and at 90-150 days after TD (maximum up to 45 months) (1 Cycle = 28 days)'}, {'measure': 'Overall Survival by PD-L1 Status, Intent to Treat Population', 'timeFrame': 'From Day 1 up to 66 months'}, {'measure': 'Progression Free Survival by PD-L1 Status, Intent to Treat Population', 'timeFrame': 'From Day 1 up to primary completion date (approximately 26 months)'}, {'measure': 'Duration of Confirmed Response (C-DoR) in (C-DoR)-Evaluable Population', 'timeFrame': 'From objective response to PD, assessed up to primary completion date (approximately 26 months)', 'description': 'C-DoR is defined as the time from the first occurrence of a documented confirmed response (CR or PR) in C-DOR evaluable population until the date of disease progression per RECIST v1.1 or death from any cause, whichever occurs first. Responses were confirmed after 8 weeks if within first 12 months or after 12 weeks if later.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Triple-Negative Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '34219000', 'type': 'DERIVED', 'citation': "Miles D, Gligorov J, Andre F, Cameron D, Schneeweiss A, Barrios C, Xu B, Wardley A, Kaen D, Andrade L, Semiglazov V, Reinisch M, Patel S, Patre M, Morales L, Patel SL, Kaul M, Barata T, O'Shaughnessy J; IMpassion131 investigators. Primary results from IMpassion131, a double-blind, placebo-controlled, randomised phase III trial of first-line paclitaxel with or without atezolizumab for unresectable locally advanced/metastatic triple-negative breast cancer. Ann Oncol. 2021 Aug;32(8):994-1004. doi: 10.1016/j.annonc.2021.05.801. Epub 2021 Jul 1."}], 'seeAlsoLinks': [{'url': 'https://www.pioneeringhealthcare.com/de/trials/breast-cancer-de/178/impassion131-de/', 'label': 'Additional information for the IMpassion131'}, {'url': 'https://www.wissen-immuntherapie.de/klinische-studien/studien-finden/', 'label': 'general information on clinical trials'}]}, 'descriptionModule': {'briefSummary': 'This Phase 3, multicenter, randomized, double-blind, placebo controlled study is designed to evaluate the efficacy and safety of atezolizumab (MPDL3280A, an anti-programmed death-ligand 1 \\[PD-L1\\] antibody) administered in combination with paclitaxel compared with placebo in combination with paclitaxel in participants with previously untreated, inoperable locally advanced or metastatic, centrally confirmed TNBC. Participants will be randomized in a 2:1 ratio to receive atezolizumab or placebo plus paclitaxel until disease progression or unacceptable toxicity or end of study, whichever occurs first (maximum up to approximately 40 months). In addition, the Sponsor may decide to terminate the study at any time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants with locally advanced or metastatic, histologically documented TNBC (absence of human epidermal growth factor receptor 2 \\[HER2\\], estrogen receptor \\[ER\\], and progesterone receptor \\[PR\\] expression), not amenable to surgical therapy\n* Participants eligible for taxane monotherapy\n* No prior chemotherapy or targeted systemic therapy (including endocrine therapy) for inoperable locally advanced or metastatic TNBC\n* Availability of formalin-fixed paraffin-embedded (FFPE) tumor block (preferred) or at least 17 unstained slides, collected ≤3 months prior to randomization, with an associated pathology report, if available. If a tumour sample taken within 3 months before randomisation is not available and a tumour biopsy is not clinically feasible, the primary surgical resection sample or the most recent FFPE tumour biopsy sample may be used. Of these additional options, the most recent sample should be used.\n* Eastern Cooperative Oncology Group performance status of 0 or 1\n* Life expectancy at least 12 weeks\n* Measurable disease, as defined by RECIST v1.1\n* Adequate hematologic and end-organ function\n* Negative human immunodeficiency virus (HIV) test at screening.\n* Negative hepatitis B surface antigen (HBsAg) test at screening\n* Negative total hepatitis B core antibody (HBcAb) test at screening, or positive HBcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening. The HBV DNA test will be performed only for patients who have a positive HBcAb test.\n* Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening. The HCV RNA test will be performed only for patients who have a positive HCV antibody test.\n* Women of child bearing potential must have a negative serum pregnancy test result within 7 days prior to initiation of study drug\n* For men and women of child bearing potential: agreement to remain abstinent or use protocol defined contraceptive measures during the treatment period and for at least 5 months after the last dose of atezolizumab/placebo, or for at least 6 months after the last dose of paclitaxel\n\nExclusion Criteria:\n\n* Spinal cord compression not definitively treated with surgery and/or radiation, or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for at least 2 weeks prior to randomization\n* Known central nervous system (CNS) disease, except for treated asymptomatic CNS metastases\n* Leptomeningeal disease\n* Uncontrolled pleural effusion, pericardial effusion, or ascites\n* Uncontrolled tumor-related pain, or uncontrolled hypercalcemia or clinically significant (symptomatic) hypercalcemia\n* Malignancies other than TNBC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or Stage I uterine cancer)\n* Pregnant or breast-feeding women, or intending to become pregnant during the study\n* Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol or interpretation of results, including significant liver disease, cardiovascular disease, and presence of an abnormal electrocardiogram (ECG)\n* Serious infection requiring antibiotics within 2 weeks prior to randomization, including but not limited to infections requiring hospitalization or IV antibiotics, such as bacteremia, or severe pneumonia\n* Major surgical procedure within 4 weeks prior to randomization or anticipation of the need for a major surgical procedure during the study other than for diagnosis\n* Treatment with investigational therapy within 30 days prior to initiation of study treatment\n* History of hypersensitivity reactions to study drug or any component of the study drug formulation'}, 'identificationModule': {'nctId': 'NCT03125902', 'acronym': 'IMpassion131', 'briefTitle': 'A Study of Atezolizumab and Paclitaxel Versus Placebo and Paclitaxel in Participants With Previously Untreated Locally Advanced or Metastatic Triple Negative Breast Cancer (TNBC)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Phase III, Multicenter, Randomised, Double-Blind, Placebo-Controlled Study of Atezolizumab (Anti-Pd-L1 Antibody) in Combination With Paclitaxel Compared With Placebo With Paclitaxel for Patients With Previously Untreated Inoperable Locally Advanced or Metastatic Triple Negative Breast Cancer', 'orgStudyIdInfo': {'id': 'MO39196'}, 'secondaryIdInfos': [{'id': '2016-004024-29', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo and Paclitaxel', 'description': 'Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.', 'interventionNames': ['Drug: Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody', 'Drug: Paclitaxel']}, {'type': 'EXPERIMENTAL', 'label': 'Atezolizumab and Paclitaxel', 'description': 'Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.', 'interventionNames': ['Drug: Atezolizumab Placebo', 'Drug: Paclitaxel']}], 'interventions': [{'name': 'Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody', 'type': 'DRUG', 'otherNames': ['MPDL3280A, TECENTRIQ'], 'description': 'Atezolizumab will be administered at a dose of 840 mg via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle.', 'armGroupLabels': ['Placebo and Paclitaxel']}, {'name': 'Atezolizumab Placebo', 'type': 'DRUG', 'description': 'Placebo matching to atezolizumab will be administered via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle.', 'armGroupLabels': ['Atezolizumab and Paclitaxel']}, {'name': 'Paclitaxel', 'type': 'DRUG', 'description': 'Paclitaxel will be administered at a dose of 90 mg/m\\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle.', 'armGroupLabels': ['Atezolizumab and Paclitaxel', 'Placebo and Paclitaxel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305-5820', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford Cancer Center', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '33901-8101', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Cancer Specialists; Department of Oncology', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '33705', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Cancer Specialist, North Region', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '30060', 'city': 'Marietta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Northwest Georgia Oncology Centers PC - Marietta', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'zip': '64132', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'HCA Midwest Health', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '07652', 'city': 'Paramus', 'state': 'New Jersey', 'country': 'United States', 'facility': 'The Valley Hospital', 'geoPoint': {'lat': 40.94454, 'lon': -74.07542}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Magee-Woman's Hospital", 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Tennessee Oncology; Sarah Cannon Research Institute', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': 'F5300COE', 'city': 'La Rioja', 'country': 'Argentina', 'facility': 'Centro Oncologico Riojano Integral (CORI)', 'geoPoint': {'lat': -29.41328, 'lon': -66.85637}}, {'zip': '29308-014', 'city': 'Cachoeiro de Itapemirim', 'state': 'Espírito Santo', 'country': 'Brazil', 'facility': 'Centro de Pesquisas Clinicas em Oncologia - CPCO', 'geoPoint': {'lat': -20.84889, 'lon': -41.11278}}, {'zip': '40050-410', 'city': 'Salvador', 'state': 'Estado de Bahia', 'country': 'Brazil', 'facility': 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