Ignite Creation Date:
2025-12-25 @ 1:15 AM
Ignite Modification Date:
2026-04-15 @ 7:08 PM
Study NCT ID:
NCT02542293
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-16
First Post:
2015-08-26
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Durvalumab With Tremelimumab Versus SoC as 1st Line Therapy in Metastatic Non Small-Cell Lung Cancer (NSCLC) (NEPTUNE)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United Arab Emirates']}, 'interventionBrowseModule': {'meshes': [{'id': 'C053518', 'term': 'CP protocol'}, {'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D000068437', 'term': 'Pemetrexed'}], 'ancestors': [{'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006147', 'term': 'Guanine'}, {'id': 'D007042', 'term': 'Hypoxanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D005971', 'term': 'Glutamates'}, {'id': 'D024342', 'term': 'Amino Acids, Acidic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000600', 'term': 'Amino Acids, Dicarboxylic'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'information.center@astrazeneca.com', 'phone': '1-877-240-9479', 'title': 'Global Clinical Lead', 'organization': 'AstraZeneca'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Analysis of the China cohort was performed to evaluate the consistency of efficacy and safety in Chinese participants with the global cohort in order to meet China health regulatory requirements and was not powered for a formal assessment of statistical significance.'}}, 'adverseEventsModule': {'timeFrame': 'Assessed until final analysis DCO for each cohort (24 June 2019 for Global Cohort and 21 September 2020 for China Cohort); maximum timeframe of approximately 44 months for each cohort.', 'description': 'Global Cohort: The safety analysis set included all participants recruited prior to end of the global recruitment who received at least 1 dose of study treatment.\n\nChina Cohort: The China safety analysis set included all participants recruited in the China cohort who received at least 1 dose of study treatment.\n\nAll-Cause Mortality: Data from participants included in Global and China FAS was summarized separately. 30 participants in China cohort were also included in Global cohort.', 'eventGroups': [{'id': 'EG000', 'title': 'Global: Durvalumab + Tremelimumab', 'description': 'Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.', 'otherNumAtRisk': 410, 'deathsNumAtRisk': 410, 'otherNumAffected': 310, 'seriousNumAtRisk': 410, 'deathsNumAffected': 328, 'seriousNumAffected': 193}, {'id': 'EG001', 'title': 'Global: SoC Chemotherapy', 'description': 'Participants received 1 of the following IV infusion treatment combinations on Day 1 of each 21-day cycle for 4 to 6 cycles or until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.\n\n1. Paclitaxel 200 mg/m\\^2 and carboplatin AUC 5 or 6 mg\\*min/mL.\n2. Gemcitabine 1000 or 1250 mg/m\\^2 and cisplatin 75 or 80 mg/m\\^2. Additional dose of gemcitabine 1000 or 1250 mg/m\\^2 on Day 8 of each cycle (For squamous participants only).\n3. Gemcitabine 1000 or 1250 mg/m\\^2 and carboplatin AUC 5 or 6 mg\\*min/mL. Additional dose of gemcitabine 1000 or 1250 mg/m\\^2 on Day 8 of each cycle (For squamous participants only).\n4. Pemetrexed 500 mg/m\\^2 and cisplatin 75 mg/m\\^2 (For non-squamous participants only; pemetrexed maintenance dose was permitted).\n5. Pemetrexed 500 mg/m\\^2 and carboplatin AUC 5 or 6 mg\\*min/mL (For non-squamous participants only; pemetrexed maintenance dose was permitted).', 'otherNumAtRisk': 399, 'deathsNumAtRisk': 413, 'otherNumAffected': 349, 'seriousNumAtRisk': 399, 'deathsNumAffected': 329, 'seriousNumAffected': 112}, {'id': 'EG002', 'title': 'China: Durvalumab + Tremelimumab', 'description': 'Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.', 'otherNumAtRisk': 77, 'deathsNumAtRisk': 78, 'otherNumAffected': 73, 'seriousNumAtRisk': 77, 'deathsNumAffected': 50, 'seriousNumAffected': 32}, {'id': 'EG003', 'title': 'China: SoC Chemotherapy', 'description': 'Participants received 1 of the following IV infusion treatment combinations on Day 1 of each 21-day cycle for 4 to 6 cycles or until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.\n\n1. Paclitaxel 200 mg/m\\^2 and carboplatin AUC 5 or 6 mg\\*min/mL.\n2. Gemcitabine 1000 or 1250 mg/m\\^2 and cisplatin 75 or 80 mg/m\\^2. Additional dose of gemcitabine 1000 or 1250 mg/m\\^2 on Day 8 of each cycle (For squamous participants only).\n3. Gemcitabine 1000 or 1250 mg/m\\^2 and carboplatin AUC 5 or 6 mg\\*min/mL. Additional dose of gemcitabine 1000 or 1250 mg/m\\^2 on Day 8 of each cycle (For squamous participants only).\n4. Pemetrexed 500 mg/m\\^2 and cisplatin 75 mg/m\\^2 (For non-squamous participants only; pemetrexed maintenance dose was permitted).\n5. Pemetrexed 500 mg/m\\^2 and carboplatin AUC 5 or 6 mg\\*min/mL (For non-squamous participants only; pemetrexed maintenance dose was permitted).', 'otherNumAtRisk': 78, 'deathsNumAtRisk': 82, 'otherNumAffected': 77, 'seriousNumAtRisk': 78, 'deathsNumAffected': 62, 'seriousNumAffected': 22}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numEvents': 66, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 399, 'numEvents': 201, 'numAffected': 146}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 35, 'numAffected': 25}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 74, 'numAffected': 53}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 399, 'numEvents': 55, 'numAffected': 38}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 21, 'numAffected': 13}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 399, 'numEvents': 113, 'numAffected': 71}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 15, 'numAffected': 10}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 399, 'numEvents': 73, 'numAffected': 50}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 11, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numEvents': 35, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numEvents': 58, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 399, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 12, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numEvents': 64, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 399, 'numEvents': 90, 'numAffected': 84}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 13, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 12, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numEvents': 96, 'numAffected': 72}, {'groupId': 'EG001', 'numAtRisk': 399, 'numEvents': 53, 'numAffected': 40}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numEvents': 74, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 399, 'numEvents': 244, 'numAffected': 128}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 13, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 108, 'numAffected': 33}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 399, 'numEvents': 40, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numEvents': 41, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 399, 'numEvents': 80, 'numAffected': 57}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 34, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numEvents': 72, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 399, 'numEvents': 59, 'numAffected': 52}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 16, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numEvents': 76, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 399, 'numEvents': 95, 'numAffected': 73}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 9, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 13, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numEvents': 30, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 399, 'numEvents': 23, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numEvents': 51, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 399, 'numEvents': 35, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 21, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 399, 'numEvents': 22, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numEvents': 39, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 399, 'numEvents': 48, 'numAffected': 34}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 27, 'numAffected': 22}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 49, 'numAffected': 22}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Amylase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 34, 'numAffected': 21}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numEvents': 35, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 399, 'numEvents': 41, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 39, 'numAffected': 25}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 38, 'numAffected': 20}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Bilirubin conjugated increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 10, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 12, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numEvents': 18, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 399, 'numEvents': 36, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 12, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Blood lactate dehydrogenase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 12, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 8, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Blood thyroid stimulating hormone decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 8, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 33, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 15, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 9, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Lipase increased', 'stats': 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'MedDRA 22.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 399, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Organising pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 399, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Pleurisy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 399, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numEvents': 17, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 399, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Pneumothorax spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 399, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 399, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Pulmonary haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 399, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 399, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Skin toxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 399, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Embolism arterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 399, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 399, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 399, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Superior vena cava stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Superior vena cava syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Venous thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 399, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Intestinal ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Anaphylactic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 399, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Spinal compression fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Type 1 diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 399, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 399, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 399, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Hypovolaemic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 410, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 399, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Survival (OS); Global Cohort: Blood Tumor Mutational Burden (bTMB) ≥20 Mutations Per Megabase (Mut/Mb) Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Global: Durvalumab + Tremelimumab', 'description': 'Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.'}, {'id': 'OG001', 'title': 'Global: SoC Chemotherapy', 'description': 'Participants received 1 of the following IV infusion treatment combinations on Day 1 of each 21-day cycle for 4 to 6 cycles or until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.\n\n1. Paclitaxel 200 mg/m\\^2 and carboplatin AUC 5 or 6 mg\\*min/mL.\n2. Gemcitabine 1000 or 1250 mg/m\\^2 and cisplatin 75 or 80 mg/m\\^2. Additional dose of gemcitabine 1000 or 1250 mg/m\\^2 on Day 8 of each cycle (For squamous participants only).\n3. Gemcitabine 1000 or 1250 mg/m\\^2 and carboplatin AUC 5 or 6 mg\\*min/mL. Additional dose of gemcitabine 1000 or 1250 mg/m\\^2 on Day 8 of each cycle (For squamous participants only).\n4. Pemetrexed 500 mg/m\\^2 and cisplatin 75 mg/m\\^2 (For non-squamous participants only; pemetrexed maintenance dose was permitted).\n5. Pemetrexed 500 mg/m\\^2 and carboplatin AUC 5 or 6 mg\\*min/mL (For non-squamous participants only; pemetrexed maintenance dose was permitted).'}], 'classes': [{'categories': [{'measurements': [{'value': '11.7', 'groupId': 'OG000', 'lowerLimit': '8.6', 'upperLimit': '15.2'}, {'value': '9.1', 'groupId': 'OG001', 'lowerLimit': '7.8', 'upperLimit': '12.6'}]}]}], 'analyses': [{'pValue': '0.0808', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.71', 'ciLowerLimit': '0.485', 'ciUpperLimit': '1.045', 'pValueComment': 'The 2-sided p-value was calculated using an unstratified log-rank test.', 'estimateComment': 'The HR and confidence interval (CI) were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.', 'groupDescription': 'Global: Durvalumab + Tremelimumab versus (Vs) Global: SoC Chemotherapy\n\nA HR \\<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From baseline (Day 1, Week 0) until death due to any cause, assessed up to the Global cohort DCO date (a maximum of approximately 44 months).', 'description': 'The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The bTMB ≥20 mut/Mb analysis set included the subset of participants in the FAS whose blood TMB status was ≥20 mut/Mb at baseline as defined by the GuardantOMNI CDx assay. Only participants randomized in Global cohort were analyzed as bTMB and tissue tumor mutational burden (tTMB) testing was not performed in China cohort.'}, {'type': 'PRIMARY', 'title': 'OS; China Cohort: China Programmed Cell Death Ligand 1 (PD-L1) Negative NSCLC Analysis Set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'China: Durvalumab + Tremelimumab', 'description': 'Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.'}, {'id': 'OG001', 'title': 'China: SoC Chemotherapy', 'description': 'Participants received 1 of the following IV infusion treatment combinations on Day 1 of each 21-day cycle for 4 to 6 cycles or until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.\n\n1. Paclitaxel 200 mg/m\\^2 and carboplatin AUC 5 or 6 mg\\*min/mL.\n2. Gemcitabine 1000 or 1250 mg/m\\^2 and cisplatin 75 or 80 mg/m\\^2. Additional dose of gemcitabine 1000 or 1250 mg/m\\^2 on Day 8 of each cycle (For squamous participants only).\n3. Gemcitabine 1000 or 1250 mg/m\\^2 and carboplatin AUC 5 or 6 mg\\*min/mL. Additional dose of gemcitabine 1000 or 1250 mg/m\\^2 on Day 8 of each cycle (For squamous participants only).\n4. Pemetrexed 500 mg/m\\^2 and cisplatin 75 mg/m\\^2 (For non-squamous participants only; pemetrexed maintenance dose was permitted).\n5. Pemetrexed 500 mg/m\\^2 and carboplatin AUC 5 or 6 mg\\*min/mL (For non-squamous participants only; pemetrexed maintenance dose was permitted).'}], 'classes': [{'categories': [{'measurements': [{'value': '15.0', 'groupId': 'OG000', 'lowerLimit': '10.5', 'upperLimit': '27.4'}, {'value': '11.7', 'groupId': 'OG001', 'lowerLimit': '8.6', 'upperLimit': '20.5'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.60', 'ciLowerLimit': '0.322', 'ciUpperLimit': '1.109', 'estimateComment': 'The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Efron approach.', 'groupDescription': 'China: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy\n\nA HR \\<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.'}], 'paramType': 'MEDIAN', 'timeFrame': 'From baseline (Day 1, Week 0) until death due to any cause, assessed up to the China cohort DCO date (a maximum of approximately 44 months).', 'description': 'The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The China PD-L1-negative population analysis set included the subset of participants in the China FAS whose PD-L1 status was PD-L1-negative at baseline as defined by the Ventana SP263 PD-L1 assay (ie, \\<1% PD-L1-membrane expression in tumoral tissue). Only participants randomized in China cohort were analyzed.'}, {'type': 'SECONDARY', 'title': 'OS; Global Cohort: bTMB ≥16 Mut/Mb, bTMB ≥12 Mut/Mb, PD-L1-Negative NSCLC, bTMB <20 Mut/Mb, bTMB Non-Evaluable Population, tTMB ≥14 Mut/Mb, tTMB ≥12 Mut/Mb, tTMB ≥10 Mut/Mb, and tTMB ≥8 Mut/Mb Analysis Sets', 'denoms': [{'units': 'Participants', 'counts': [{'value': '410', 'groupId': 'OG000'}, {'value': '413', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Global: Durvalumab + Tremelimumab', 'description': 'Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.'}, {'id': 'OG001', 'title': 'Global: SoC Chemotherapy', 'description': 'Participants received 1 of the following IV infusion treatment combinations on Day 1 of each 21-day cycle for 4 to 6 cycles or until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.\n\n1. Paclitaxel 200 mg/m\\^2 and carboplatin AUC 5 or 6 mg\\*min/mL.\n2. Gemcitabine 1000 or 1250 mg/m\\^2 and cisplatin 75 or 80 mg/m\\^2. Additional dose of gemcitabine 1000 or 1250 mg/m\\^2 on Day 8 of each cycle (For squamous participants only).\n3. Gemcitabine 1000 or 1250 mg/m\\^2 and carboplatin AUC 5 or 6 mg\\*min/mL. Additional dose of gemcitabine 1000 or 1250 mg/m\\^2 on Day 8 of each cycle (For squamous participants only).\n4. Pemetrexed 500 mg/m\\^2 and cisplatin 75 mg/m\\^2 (For non-squamous participants only; pemetrexed maintenance dose was permitted).\n5. Pemetrexed 500 mg/m\\^2 and carboplatin AUC 5 or 6 mg\\*min/mL (For non-squamous participants only; pemetrexed maintenance dose was permitted).'}], 'classes': [{'title': 'bTMB ≥16 mut/Mb analysis set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.1', 'groupId': 'OG000', 'lowerLimit': '8.6', 'upperLimit': '15.0'}, {'value': '11.9', 'groupId': 'OG001', 'lowerLimit': '8.5', 'upperLimit': '15.9'}]}]}, {'title': 'bTMB ≥12 mut/Mb analysis set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.9', 'groupId': 'OG000', 'lowerLimit': '8.6', 'upperLimit': '12.6'}, {'value': '10.3', 'groupId': 'OG001', 'lowerLimit': '8.3', 'upperLimit': '12.9'}]}]}, {'title': 'PD-L1 negative analysis set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.1', 'groupId': 'OG000', 'lowerLimit': '8.1', 'upperLimit': '14.7'}, {'value': '12.5', 'groupId': 'OG001', 'lowerLimit': '9.9', 'upperLimit': '16.2'}]}]}, {'title': 'bTMB <20 mut/Mb analysis set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '186', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.9', 'groupId': 'OG000', 'lowerLimit': '7.7', 'upperLimit': '12.8'}, {'value': '11.5', 'groupId': 'OG001', 'lowerLimit': '8.8', 'upperLimit': '13.7'}]}]}, {'title': 'bTMB non-evaluable analysis set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.3', 'groupId': 'OG000', 'lowerLimit': '7.2', 'upperLimit': '15.5'}, {'value': '10.4', 'groupId': 'OG001', 'lowerLimit': '9.4', 'upperLimit': '13.8'}]}]}, {'title': 'tTMB ≥14 mut/Mb analysis set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.5', 'comment': 'Upper limit was not reached.', 'groupId': 'OG000', 'lowerLimit': '9.8', 'upperLimit': 'NA'}, {'value': '10.6', 'groupId': 'OG001', 'lowerLimit': '7.0', 'upperLimit': '20.9'}]}]}, {'title': 'tTMB ≥12 mut/Mb analysis set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.1', 'groupId': 'OG000', 'lowerLimit': '7.0', 'upperLimit': '17.5'}, {'value': '13.9', 'groupId': 'OG001', 'lowerLimit': '9.0', 'upperLimit': '17.9'}]}]}, {'title': 'tTMB ≥10 mut/Mb analysis set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.1', 'groupId': 'OG000', 'lowerLimit': '7.2', 'upperLimit': '15.7'}, {'value': '10.6', 'groupId': 'OG001', 'lowerLimit': '9.0', 'upperLimit': '15.7'}]}]}, {'title': 'tTMB ≥8 mut/Mb analysis set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.0', 'groupId': 'OG000', 'lowerLimit': '7.8', 'upperLimit': '15.7'}, {'value': '10.2', 'groupId': 'OG001', 'lowerLimit': '8.0', 'upperLimit': '13.5'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.87', 'ciLowerLimit': '0.629', 'ciUpperLimit': '1.201', 'estimateComment': 'The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.', 'groupDescription': 'bTMB ≥16 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy\n\nA HR \\<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.94', 'ciLowerLimit': '0.726', 'ciUpperLimit': '1.213', 'estimateComment': 'The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.', 'groupDescription': 'bTMB ≥12 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy\n\nA HR \\<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.07', 'ciLowerLimit': '0.786', 'ciUpperLimit': '1.464', 'estimateComment': 'The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with ties handled by the Efron approach.', 'groupDescription': 'PD-L1 negative analysis set:\n\nGlobal: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy\n\nA HR \\<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.04', 'ciLowerLimit': '0.835', 'ciUpperLimit': '1.302', 'estimateComment': 'The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.', 'groupDescription': 'bTMB \\<20 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy\n\nA HR \\<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '0.758', 'ciUpperLimit': '1.353', 'estimateComment': 'The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.', 'groupDescription': 'bTMB non-evaluable analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy\n\nA HR \\<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.57', 'ciLowerLimit': '0.309', 'ciUpperLimit': '1.008', 'estimateComment': 'The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.', 'groupDescription': 'tTMB ≥14 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy\n\nA HR \\<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.87', 'ciLowerLimit': '0.560', 'ciUpperLimit': '1.350', 'estimateComment': 'The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.', 'groupDescription': 'tTMB ≥12 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy\n\nA HR \\<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.88', 'ciLowerLimit': '0.614', 'ciUpperLimit': '1.251', 'estimateComment': 'The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.', 'groupDescription': 'tTMB ≥10 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy\n\nA HR \\<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.78', 'ciLowerLimit': '0.564', 'ciUpperLimit': '1.080', 'estimateComment': 'The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.', 'groupDescription': 'tTMB ≥8 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy\n\nA HR \\<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From baseline (Day 1, Week 0) until death due to any cause, assessed up to the Global cohort DCO date (a maximum of approximately 44 months).', 'description': 'OS was defined as time from date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at time of analysis was censored based on last recorded date on which participant was known to be alive.\n\nbTMB ≥16 mut/Mb, bTMB ≥12 mut/Mb and bTMB \\<20 mut/Mb analysis sets included the subset of participants in FAS whose bTMB status was ≥16 mut/Mb, ≥12 mut/Mb and \\<20 mut/Mb, respectively at baseline as defined by the GuardantOMNI CDx assay.\n\nPD-L1-negative analysis set included the subset of participants in FAS whose PD-L1 status was PD-L1-negative at baseline as defined by the Ventana SP263 PD-L1 Assay (ie, \\<1% PD-L1-membrane expression in tumoral tissue).\n\nbTMB non-evaluable analysis set included the subset of participants in FAS whose bTMB status at baseline could not be determined by the GuardantOMNI CDx assay or whose sample was not available.\n\ntTMB analysis sets are defined same as the bTMB analysis sets.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants included in bTMB ≥16 mut/Mb, bTMB ≥12 mut/Mb, PD-L1-Negative NSCLC, bTMB \\<20 mut/Mb, bTMB non-evaluable population, tTMB ≥14 mut/Mb, tTMB ≥12 mut/Mb, tTMB ≥10 mut/Mb, and tTMB ≥8 mut/Mb analysis sets are reported in this outcome measure. Only participants randomized in Global cohort were analyzed as bTMB and tTMB testing was not performed in China cohort.'}, {'type': 'SECONDARY', 'title': 'OS; Global and China Cohorts: FAS, PD-L1 Tumor Cell (TC) ≥25%, and PD-L1 TC ≥50% Analysis Sets', 'denoms': [{'units': 'Participants', 'counts': [{'value': '410', 'groupId': 'OG000'}, {'value': '413', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '82', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Global: Durvalumab + Tremelimumab', 'description': 'Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.'}, {'id': 'OG001', 'title': 'Global: SoC Chemotherapy', 'description': 'Participants received 1 of the following IV infusion treatment combinations on Day 1 of each 21-day cycle for 4 to 6 cycles or until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.\n\n1. Paclitaxel 200 mg/m\\^2 and carboplatin AUC 5 or 6 mg\\*min/mL.\n2. Gemcitabine 1000 or 1250 mg/m\\^2 and cisplatin 75 or 80 mg/m\\^2. Additional dose of gemcitabine 1000 or 1250 mg/m\\^2 on Day 8 of each cycle (For squamous participants only).\n3. Gemcitabine 1000 or 1250 mg/m\\^2 and carboplatin AUC 5 or 6 mg\\*min/mL. Additional dose of gemcitabine 1000 or 1250 mg/m\\^2 on Day 8 of each cycle (For squamous participants only).\n4. Pemetrexed 500 mg/m\\^2 and cisplatin 75 mg/m\\^2 (For non-squamous participants only; pemetrexed maintenance dose was permitted).\n5. Pemetrexed 500 mg/m\\^2 and carboplatin AUC 5 or 6 mg\\*min/mL (For non-squamous participants only; pemetrexed maintenance dose was permitted).'}, {'id': 'OG002', 'title': 'China: Durvalumab + Tremelimumab', 'description': 'Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.'}, {'id': 'OG003', 'title': 'China: SoC Chemotherapy', 'description': 'Participants received 1 of the following IV infusion treatment combinations on Day 1 of each 21-day cycle for 4 to 6 cycles or until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.\n\n1. Paclitaxel 200 mg/m\\^2 and carboplatin AUC 5 or 6 mg\\*min/mL.\n2. Gemcitabine 1000 or 1250 mg/m\\^2 and cisplatin 75 or 80 mg/m\\^2. Additional dose of gemcitabine 1000 or 1250 mg/m\\^2 on Day 8 of each cycle (For squamous participants only).\n3. Gemcitabine 1000 or 1250 mg/m\\^2 and carboplatin AUC 5 or 6 mg\\*min/mL. Additional dose of gemcitabine 1000 or 1250 mg/m\\^2 on Day 8 of each cycle (For squamous participants only).\n4. Pemetrexed 500 mg/m\\^2 and cisplatin 75 mg/m\\^2 (For non-squamous participants only; pemetrexed maintenance dose was permitted).\n5. Pemetrexed 500 mg/m\\^2 and carboplatin AUC 5 or 6 mg\\*min/mL (For non-squamous participants only; pemetrexed maintenance dose was permitted).'}], 'classes': [{'title': 'FAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '410', 'groupId': 'OG000'}, {'value': '413', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '82', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10.9', 'groupId': 'OG000', 'lowerLimit': '9.3', 'upperLimit': '12.6'}, {'value': '12.1', 'groupId': 'OG001', 'lowerLimit': '10.3', 'upperLimit': '13.5'}, {'value': '20.0', 'groupId': 'OG002', 'lowerLimit': '15.0', 'upperLimit': '28.7'}, {'value': '14.1', 'groupId': 'OG003', 'lowerLimit': '9.5', 'upperLimit': '19.4'}]}]}, {'title': 'PD-L1 TC ≥25% analysis set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '12.2', 'groupId': 'OG000', 'lowerLimit': '9.7', 'upperLimit': '15.2'}, {'value': '10.4', 'groupId': 'OG001', 'lowerLimit': '8.6', 'upperLimit': '12.2'}, {'value': '36.6', 'comment': 'Upper limit was not reached.', 'groupId': 'OG002', 'lowerLimit': '15.5', 'upperLimit': 'NA'}, {'value': '15.8', 'groupId': 'OG003', 'lowerLimit': '9.0', 'upperLimit': '26.9'}]}]}, {'title': 'PD-L1 TC ≥50% analysis set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '14.1', 'groupId': 'OG000', 'lowerLimit': '10.0', 'upperLimit': '19.3'}, {'value': '10.5', 'groupId': 'OG001', 'lowerLimit': '8.7', 'upperLimit': '12.6'}, {'value': '36.6', 'comment': 'Upper limit was not reached.', 'groupId': 'OG002', 'lowerLimit': '16.9', 'upperLimit': 'NA'}, {'value': '15.8', 'groupId': 'OG003', 'lowerLimit': '9.0', 'upperLimit': '26.9'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.02', 'ciLowerLimit': '0.871', 'ciUpperLimit': '1.186', 'estimateComment': 'The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (≥25% Vs \\<25%), smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with ties handled by Efron approach.', 'groupDescription': 'FAS:\n\nGlobal: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy\n\nA HR \\<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.70', 'ciLowerLimit': '0.480', 'ciUpperLimit': '1.018', 'estimateComment': 'The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\\>= 25% Vs \\< 25 and histology (squamous Vs non-squamous), with ties handled by the Efron approach.', 'groupDescription': 'FAS:\n\nChina: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy\n\nA HR \\<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.84', 'ciLowerLimit': '0.654', 'ciUpperLimit': '1.078', 'estimateComment': 'The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with ties handled by the Efron approach.', 'groupDescription': 'PD-L1 TC ≥25% analysis set:\n\nGlobal: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy\n\nA HR \\<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.56', 'ciLowerLimit': '0.289', 'ciUpperLimit': '1.065', 'estimateComment': 'The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Efron approach.', 'groupDescription': 'PD-L1 TC ≥ 25% analysis set:\n\nChina: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy\n\nA HR \\<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.80', 'ciLowerLimit': '0.587', 'ciUpperLimit': '1.081', 'estimateComment': 'The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with ties handled by the Efron approach.', 'groupDescription': 'PD-L1 TC ≥50% analysis set:\n\nGlobal: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy\n\nA HR \\<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.47', 'ciLowerLimit': '0.222', 'ciUpperLimit': '0.955', 'estimateComment': 'The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Efron approach.', 'groupDescription': 'PD-L1 TC ≥50% analysis set:\n\nChina: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy\n\nA HR \\<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer OS than SoC.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.'}], 'paramType': 'MEDIAN', 'timeFrame': 'From baseline (Day 1, Week 0) until death due to any cause, assessed up to the Global or China cohort DCO dates, as applicable (a maximum of approximately 44 months) for each cohort.', 'description': 'The OS was defined as time from date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis was censored based on last recorded date on which participant was known to be alive.\n\nGlobal Cohort: The FAS included all randomized participants prior to the end of global recruitment. Any participants recruited in China, after global recruitment had ended, were not included in the FAS.\n\nChina Cohort: The China FAS included all randomized participants in the China cohort and were used for all China only efficacy analyses.\n\nPD-L1 TC ≥25% and PD-L1 TC ≥50% analysis sets included the subset of participants in the FAS whose PD-L1 status was TC ≥25% and TC ≥50% membrane expression in tumoral tissue, respectively at baseline as defined by the Ventana SP263 PD-L1 Assay.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants included in FAS, PD-L1 TC ≥25%, and PD-L1 TC ≥50% analysis sets are reported in this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Progression-Free Survival (PFS); Global Cohort: bTMB ≥20 Mut/Mb, bTMB ≥16 Mut/Mb, bTMB ≥12 Mut/Mb, tTMB ≥14 Mut/Mb, tTMB ≥12 Mut/Mb, tTMB ≥10 Mut/Mb, and tTMB ≥8 Mut/Mb Analysis Sets', 'denoms': [{'units': 'Participants', 'counts': [{'value': '410', 'groupId': 'OG000'}, {'value': '413', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Global: Durvalumab + Tremelimumab', 'description': 'Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.'}, {'id': 'OG001', 'title': 'Global: SoC Chemotherapy', 'description': 'Participants received 1 of the following IV infusion treatment combinations on Day 1 of each 21-day cycle for 4 to 6 cycles or until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.\n\n1. Paclitaxel 200 mg/m\\^2 and carboplatin AUC 5 or 6 mg\\*min/mL.\n2. Gemcitabine 1000 or 1250 mg/m\\^2 and cisplatin 75 or 80 mg/m\\^2. Additional dose of gemcitabine 1000 or 1250 mg/m\\^2 on Day 8 of each cycle (For squamous participants only).\n3. Gemcitabine 1000 or 1250 mg/m\\^2 and carboplatin AUC 5 or 6 mg\\*min/mL. Additional dose of gemcitabine 1000 or 1250 mg/m\\^2 on Day 8 of each cycle (For squamous participants only).\n4. Pemetrexed 500 mg/m\\^2 and cisplatin 75 mg/m\\^2 (For non-squamous participants only; pemetrexed maintenance dose was permitted).\n5. Pemetrexed 500 mg/m\\^2 and carboplatin AUC 5 or 6 mg\\*min/mL (For non-squamous participants only; pemetrexed maintenance dose was permitted).'}], 'classes': [{'title': 'bTMB ≥20 mut/Mb analysis set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '5.6'}, {'value': '5.1', 'groupId': 'OG001', 'lowerLimit': '4.2', 'upperLimit': '5.6'}]}]}, {'title': 'bTMB ≥16 mut/Mb analysis set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000', 'lowerLimit': '2.8', 'upperLimit': '5.5'}, {'value': '5.5', 'groupId': 'OG001', 'lowerLimit': '4.4', 'upperLimit': '5.8'}]}]}, {'title': 'bTMB ≥12 mut/Mb analysis set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.9', 'groupId': 'OG000', 'lowerLimit': '2.8', 'upperLimit': '4.8'}, {'value': '5.1', 'groupId': 'OG001', 'lowerLimit': '4.4', 'upperLimit': '5.6'}]}]}, {'title': 'tTMB ≥14 mut/Mb analysis set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.7', 'groupId': 'OG000', 'lowerLimit': '5.2', 'upperLimit': '22.3'}, {'value': '5.8', 'groupId': 'OG001', 'lowerLimit': '4.4', 'upperLimit': '7.9'}]}]}, {'title': 'tTMB ≥12 mut/Mb analysis set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.2', 'groupId': 'OG000', 'lowerLimit': '3.8', 'upperLimit': '6.9'}, {'value': '5.8', 'groupId': 'OG001', 'lowerLimit': '4.2', 'upperLimit': '6.6'}]}]}, {'title': 'tTMB ≥10 mut/Mb analysis set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG000', 'lowerLimit': '2.8', 'upperLimit': '5.5'}, {'value': '5.1', 'groupId': 'OG001', 'lowerLimit': '4.2', 'upperLimit': '5.8'}]}]}, {'title': 'tTMB ≥8 mut/Mb analysis set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.4', 'groupId': 'OG000', 'lowerLimit': '2.9', 'upperLimit': '5.5'}, {'value': '5.0', 'groupId': 'OG001', 'lowerLimit': '4.2', 'upperLimit': '5.6'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.77', 'ciLowerLimit': '0.514', 'ciUpperLimit': '1.146', 'estimateComment': 'The HR and CI interval were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.', 'groupDescription': 'bTMB ≥20 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy\n\nA HR \\<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.86', 'ciLowerLimit': '0.623', 'ciUpperLimit': '1.189', 'estimateComment': 'The HR and CI interval were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.', 'groupDescription': 'bTMB ≥16 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy\n\nA HR \\<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.92', 'ciLowerLimit': '0.714', 'ciUpperLimit': '1.193', 'estimateComment': 'The HR and CI interval were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.', 'groupDescription': 'bTMB ≥12 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy\n\nA HR \\<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.46', 'ciLowerLimit': '0.258', 'ciUpperLimit': '0.818', 'estimateComment': 'The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.', 'groupDescription': 'tTMB ≥14 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy\n\nA HR \\<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.80', 'ciLowerLimit': '0.524', 'ciUpperLimit': '1.228', 'estimateComment': 'The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.', 'groupDescription': 'tTMB ≥12 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy\n\nA HR \\<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.83', 'ciLowerLimit': '0.585', 'ciUpperLimit': '1.177', 'estimateComment': 'The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.', 'groupDescription': 'tTMB ≥10 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy\n\nA HR \\<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.74', 'ciLowerLimit': '0.534', 'ciUpperLimit': '1.017', 'estimateComment': 'The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.', 'groupDescription': 'tTMB ≥8 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy\n\nA HR \\<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Tumour scans performed at baseline and every 6 weeks up to 48 weeks relative to date of randomization, then every 8 weeks thereafter until confirmed PD/death. Up to Global cohort DCO date (approximately 44 months).', 'description': 'The PFS (per Response Evaluation Criteria in Solid Tumors, version 1.1 \\[RECIST 1.1\\] using Investigator assessments) was defined as the time from the date of randomization until the date of objective PD or death (by any cause in the absence of progression) regardless of whether the participant withdrew from randomized therapy or received another anticancer therapy prior to progression (ie, date of PFS event or censoring - date of randomization + 1).\n\nbTMB ≥20 mut/Mb, bTMB ≥16 mut/Mb and bTMB ≥12 mut/Mb analysis sets included the subset of participants in FAS whose bTMB status was ≥20 mut/Mb, ≥16 mut/Mb and ≥12 mut/Mb, respectively at baseline as defined by the GuardantOMNI CDx assay.\n\ntTMB ≥14 mut/Mb, tTMB ≥12 mut/Mb, tTMB ≥10 mut/Mb and tTMB ≥8 mut/Mb analysis sets included the subset of participants in FAS whose tTMB status was ≥14 mut/Mb, ≥12 mut/Mb, ≥10 mut/Mb and ≥8 mut/Mb, respectively at baseline as defined by the GuardantOMNI CDx assay.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants included in bTMB ≥20 mut/Mb, bTMB ≥16 mut/Mb, bTMB ≥12 mut/Mb, tTMB ≥14 mut/Mb, tTMB ≥12 mut/Mb, tTMB ≥10 mut/Mb, and tTMB ≥8 mut/Mb analysis sets are reported in this outcome measure. Only participants randomized in Global cohort were analyzed as bTMB and tTMB testing was not performed in China cohort.'}, {'type': 'SECONDARY', 'title': 'PFS; Global and China Cohorts: PD-L1-Negative NSCLC, FAS, PD-L1 TC ≥25%, and PD-L1 TC ≥50% Analysis Sets', 'denoms': [{'units': 'Participants', 'counts': [{'value': '410', 'groupId': 'OG000'}, {'value': '413', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '82', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Global: Durvalumab + Tremelimumab', 'description': 'Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.'}, {'id': 'OG001', 'title': 'Global: SoC Chemotherapy', 'description': 'Participants received 1 of the following IV infusion treatment combinations on Day 1 of each 21-day cycle for 4 to 6 cycles or until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.\n\n1. Paclitaxel 200 mg/m\\^2 and carboplatin AUC 5 or 6 mg\\*min/mL.\n2. Gemcitabine 1000 or 1250 mg/m\\^2 and cisplatin 75 or 80 mg/m\\^2. Additional dose of gemcitabine 1000 or 1250 mg/m\\^2 on Day 8 of each cycle (For squamous participants only).\n3. Gemcitabine 1000 or 1250 mg/m\\^2 and carboplatin AUC 5 or 6 mg\\*min/mL. Additional dose of gemcitabine 1000 or 1250 mg/m\\^2 on Day 8 of each cycle (For squamous participants only).\n4. Pemetrexed 500 mg/m\\^2 and cisplatin 75 mg/m\\^2 (For non-squamous participants only; pemetrexed maintenance dose was permitted).\n5. Pemetrexed 500 mg/m\\^2 and carboplatin AUC 5 or 6 mg\\*min/mL (For non-squamous participants only; pemetrexed maintenance dose was permitted).'}, {'id': 'OG002', 'title': 'China: Durvalumab + Tremelimumab', 'description': 'Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.'}, {'id': 'OG003', 'title': 'China: SoC Chemotherapy', 'description': 'Participants received 1 of the following IV infusion treatment combinations on Day 1 of each 21-day cycle for 4 to 6 cycles or until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.\n\n1. Paclitaxel 200 mg/m\\^2 and carboplatin AUC 5 or 6 mg\\*min/mL.\n2. Gemcitabine 1000 or 1250 mg/m\\^2 and cisplatin 75 or 80 mg/m\\^2. Additional dose of gemcitabine 1000 or 1250 mg/m\\^2 on Day 8 of each cycle (For squamous participants only).\n3. Gemcitabine 1000 or 1250 mg/m\\^2 and carboplatin AUC 5 or 6 mg\\*min/mL. Additional dose of gemcitabine 1000 or 1250 mg/m\\^2 on Day 8 of each cycle (For squamous participants only).\n4. Pemetrexed 500 mg/m\\^2 and cisplatin 75 mg/m\\^2 (For non-squamous participants only; pemetrexed maintenance dose was permitted).\n5. Pemetrexed 500 mg/m\\^2 and carboplatin AUC 5 or 6 mg\\*min/mL (For non-squamous participants only; pemetrexed maintenance dose was permitted).'}], 'classes': [{'title': 'PD-L1-negative NSCLC analysis set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000', 'lowerLimit': '2.8', 'upperLimit': '5.2'}, {'value': '5.6', 'groupId': 'OG001', 'lowerLimit': '4.6', 'upperLimit': '6.0'}, {'value': '5.1', 'groupId': 'OG002', 'lowerLimit': '2.8', 'upperLimit': '7.2'}, {'value': '6.0', 'groupId': 'OG003', 'lowerLimit': '4.0', 'upperLimit': '7.5'}]}]}, {'title': 'FAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '410', 'groupId': 'OG000'}, {'value': '413', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '82', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000', 'lowerLimit': '2.9', 'upperLimit': '4.2'}, {'value': '5.6', 'groupId': 'OG001', 'lowerLimit': '5.3', 'upperLimit': '5.7'}, {'value': '4.2', 'groupId': 'OG002', 'lowerLimit': '2.8', 'upperLimit': '7.2'}, {'value': '6.0', 'groupId': 'OG003', 'lowerLimit': '5.5', 'upperLimit': '7.5'}]}]}, {'title': 'PD-L1 TC ≥25% analysis set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000', 'lowerLimit': '3.2', 'upperLimit': '5.7'}, {'value': '5.4', 'groupId': 'OG001', 'lowerLimit': '4.4', 'upperLimit': '5.6'}, {'value': '6.8', 'groupId': 'OG002', 'lowerLimit': '4.1', 'upperLimit': '8.4'}, {'value': '5.7', 'groupId': 'OG003', 'lowerLimit': '4.2', 'upperLimit': '8.5'}]}]}, {'title': 'PD-L1 TC ≥50% analysis set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.6', 'groupId': 'OG000', 'lowerLimit': '3.1', 'upperLimit': '6.0'}, {'value': '5.4', 'groupId': 'OG001', 'lowerLimit': '4.3', 'upperLimit': '5.6'}, {'value': '6.8', 'groupId': 'OG002', 'lowerLimit': '4.2', 'upperLimit': '20.2'}, {'value': '5.7', 'groupId': 'OG003', 'lowerLimit': '4.2', 'upperLimit': '8.5'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.11', 'ciLowerLimit': '0.810', 'ciUpperLimit': '1.517', 'estimateComment': 'The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with ties handled by the Efron approach.', 'groupDescription': 'PD-L1-negative analysis set:\n\nGlobal: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy\n\nA HR \\<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.13', 'ciLowerLimit': '0.592', 'ciUpperLimit': '2.141', 'estimateComment': 'The HR and CI interval were calculated using an stratified Cox proportional hazards model, adjusting histology (squamous Vs non-squamous), with ties handled by the Efron approach.', 'groupDescription': 'PD-L1-negative analysis set:\n\nChina: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy\n\nA HR \\<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.08', 'ciLowerLimit': '0.924', 'ciUpperLimit': '1.253', 'estimateComment': 'The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (≥25% Vs \\<25%), smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with ties handled by Efron approach.', 'groupDescription': 'FAS:\n\nGlobal: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy\n\nA HR \\<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.95', 'ciLowerLimit': '0.655', 'ciUpperLimit': '1.362', 'estimateComment': 'The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (≥ 25% Vs \\< 25%) and histology (squamous Vs non-squamous), with ties handled by the Efron approach.', 'groupDescription': 'FAS:\n\nChina: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy\n\nA HR \\<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.80', 'ciLowerLimit': '0.621', 'ciUpperLimit': '1.024', 'estimateComment': 'The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with ties handled by the Efron approach.', 'groupDescription': 'PD-L1 TC ≥25% analysis set:\n\nGlobal: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy\n\nA HR \\<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.72', 'ciLowerLimit': '0.389', 'ciUpperLimit': '1.317', 'estimateComment': 'The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Efron approach.', 'groupDescription': 'PD-L1 TC ≥ 25% analysis set:\n\nChina: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy\n\nA HR \\<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.74', 'ciLowerLimit': '0.542', 'ciUpperLimit': '1.010', 'estimateComment': 'The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with ties handled by the Efron approach.', 'groupDescription': 'PD-L1 TC ≥50% analysis set:\n\nGlobal: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy\n\nA HR \\<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.65', 'ciLowerLimit': '0.335', 'ciUpperLimit': '1.251', 'estimateComment': 'The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Efron approach.', 'groupDescription': 'PD-L1 TC ≥50% analysis set:\n\nChina: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy\n\nA HR \\<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer PFS than SoC.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Tumour scans performed at baseline and every 6 weeks up to 48 weeks relative to date of randomization, then every 8 weeks thereafter until confirmed PD/death. Up to Global or China cohort DCO dates, as applicable (approximately 44 months) for each cohort.', 'description': 'PFS (per RECIST 1.1 using Investigator assessments) was defined as time from date of randomization until date of objective PD or death regardless of whether participant withdrew from randomized therapy or received another anticancer therapy prior to progression (ie, date of PFS event or censoring - date of randomization + 1).\n\nPD-L1-negative analysis set included subset of participants in FAS whose PD-L1 status was PD-L1-negative at baseline as defined by Ventana SP263 PD-L1 Assay (ie, \\<1% PD-L1-membrane expression in tumoral tissue).\n\nGlobal Cohort: FAS included all randomized participants prior to end of global recruitment.\n\nChina Cohort: China FAS included all randomized participants in China cohort and were used for all China only efficacy analyses.\n\nPD-L1 TC ≥25% and PD-L1 TC ≥50% analysis sets included subset of participants in FAS whose PD-L1 status was TC ≥25% and TC ≥50% membrane expression in tumoral tissue, respectively at baseline as defined by the Ventana SP263 PD-L1 Assay.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants included in PD-L1-negative NSCLC, FAS, PD-L1 TC ≥25%, and PD-L1 TC ≥50% analysis sets are reported in this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate (ORR); Global Cohort: bTMB ≥20 Mut/Mb, bTMB ≥16 Mut/Mb, bTMB ≥12 Mut/Mb, tTMB ≥14 Mut/Mb, tTMB ≥12 Mut/Mb, tTMB ≥10 Mut/Mb, and tTMB ≥8 Mut/Mb Analysis Sets', 'denoms': [{'units': 'Participants', 'counts': [{'value': '410', 'groupId': 'OG000'}, {'value': '413', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Global: Durvalumab + Tremelimumab', 'description': 'Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.'}, {'id': 'OG001', 'title': 'Global: SoC Chemotherapy', 'description': 'Participants received 1 of the following IV infusion treatment combinations on Day 1 of each 21-day cycle for 4 to 6 cycles or until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.\n\n1. Paclitaxel 200 mg/m\\^2 and carboplatin AUC 5 or 6 mg\\*min/mL.\n2. Gemcitabine 1000 or 1250 mg/m\\^2 and cisplatin 75 or 80 mg/m\\^2. Additional dose of gemcitabine 1000 or 1250 mg/m\\^2 on Day 8 of each cycle (For squamous participants only).\n3. Gemcitabine 1000 or 1250 mg/m\\^2 and carboplatin AUC 5 or 6 mg\\*min/mL. Additional dose of gemcitabine 1000 or 1250 mg/m\\^2 on Day 8 of each cycle (For squamous participants only).\n4. Pemetrexed 500 mg/m\\^2 and cisplatin 75 mg/m\\^2 (For non-squamous participants only; pemetrexed maintenance dose was permitted).\n5. Pemetrexed 500 mg/m\\^2 and carboplatin AUC 5 or 6 mg\\*min/mL (For non-squamous participants only; pemetrexed maintenance dose was permitted).'}], 'classes': [{'title': 'bTMB ≥20 mut/Mb analysis set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27.5', 'groupId': 'OG000'}, {'value': '43.3', 'groupId': 'OG001'}]}]}, {'title': 'bTMB ≥16 mut/Mb analysis set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '31.2', 'groupId': 'OG000'}, {'value': '46.1', 'groupId': 'OG001'}]}]}, {'title': 'bTMB ≥12 mut/Mb analysis set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28.7', 'groupId': 'OG000'}, {'value': '42.0', 'groupId': 'OG001'}]}]}, {'title': 'tTMB ≥14 mut/Mb analysis set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '61.3', 'groupId': 'OG000'}, {'value': '44.7', 'groupId': 'OG001'}]}]}, {'title': 'tTMB ≥12 mut/Mb analysis set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42.6', 'groupId': 'OG000'}, {'value': '41.8', 'groupId': 'OG001'}]}]}, {'title': 'tTMB ≥10 mut/Mb analysis set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '37.7', 'groupId': 'OG000'}, {'value': '42.5', 'groupId': 'OG001'}]}]}, {'title': 'tTMB ≥8 mut/Mb analysis set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36.7', 'groupId': 'OG000'}, {'value': '41.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.50', 'ciLowerLimit': '0.236', 'ciUpperLimit': '1.030', 'groupDescription': 'bTMB ≥20 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy\n\nAn odds ratio \\>1 favors Durvalumab + Tremelimumab combination therapy over SoC.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.53', 'ciLowerLimit': '0.288', 'ciUpperLimit': '0.968', 'groupDescription': 'bTMB ≥16 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy\n\nAn odds ratio \\>1 favors Durvalumab + Tremelimumab combination therapy over SoC.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.55', 'ciLowerLimit': '0.336', 'ciUpperLimit': '0.908', 'groupDescription': 'bTMB ≥12 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy\n\nAn odds ratio \\>1 favors Durvalumab + Tremelimumab combination therapy over SoC.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.96', 'ciLowerLimit': '0.752', 'ciUpperLimit': '5.234', 'groupDescription': 'tTMB ≥14 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy\n\nAn odds ratio \\>1 favors Durvalumab + Tremelimumab combination therapy over SoC.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.03', 'ciLowerLimit': '0.482', 'ciUpperLimit': '2.214', 'groupDescription': 'tTMB ≥12 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy\n\nAn odds ratio \\>1 favors Durvalumab + Tremelimumab combination therapy over SoC.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.82', 'ciLowerLimit': '0.430', 'ciUpperLimit': '1.548', 'groupDescription': 'tTMB ≥10 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy\n\nAn odds ratio \\>1 favors Durvalumab + Tremelimumab combination therapy over SoC.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.83', 'ciLowerLimit': '0.456', 'ciUpperLimit': '1.486', 'groupDescription': 'tTMB ≥8 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy\n\nAn odds ratio \\>1 favors Durvalumab + Tremelimumab combination therapy over SoC.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Tumour scans performed at baseline and every 6 weeks up to 48 weeks relative to date of randomization, then every 8 weeks thereafter until confirmed PD/death. Up to Global cohort DCO date (approximately 44 months).', 'description': 'The ORR (per RECIST 1.1 using Investigator assessments) was defined as the percentage of participants with at least 1 visit response of complete response (CR) or partial response (PR) prior to PD.\n\nbTMB ≥20 mut/Mb, bTMB ≥16 mut/Mb and bTMB ≥12 mut/Mb analysis sets included the subset of participants in FAS whose bTMB status was ≥20 mut/Mb, ≥16 mut/Mb and ≥12 mut/Mb, respectively at baseline as defined by the GuardantOMNI CDx assay.\n\ntTMB ≥14 mut/Mb, tTMB ≥12 mut/Mb, tTMB ≥10 mut/Mb and tTMB ≥8 mut/Mb analysis sets included the subset of participants in FAS whose tTMB status was ≥14 mut/Mb, ≥12 mut/Mb, ≥10 mut/Mb and ≥8 mut/Mb, respectively at baseline as defined by the GuardantOMNI CDx assay.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants included in bTMB ≥20 mut/Mb, bTMB ≥16 mut/Mb, bTMB ≥12 mut/Mb, tTMB ≥14 mut/Mb, tTMB ≥12 mut/Mb, tTMB ≥10 mut/Mb, and tTMB ≥8 mut/Mb analysis sets with measurable disease are reported in this outcome measure. Only participants randomized in Global cohort were analyzed as bTMB and tTMB testing was not performed in China cohort.'}, {'type': 'SECONDARY', 'title': 'ORR; Global and China Cohorts: PD-L1-Negative NSCLC, FAS, PD-L1 TC ≥25%, and PD-L1 TC ≥50% Analysis Sets', 'denoms': [{'units': 'Participants', 'counts': [{'value': '410', 'groupId': 'OG000'}, {'value': '413', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '82', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Global: Durvalumab + Tremelimumab', 'description': 'Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.'}, {'id': 'OG001', 'title': 'Global: SoC Chemotherapy', 'description': 'Participants received 1 of the following IV infusion treatment combinations on Day 1 of each 21-day cycle for 4 to 6 cycles or until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.\n\n1. Paclitaxel 200 mg/m\\^2 and carboplatin AUC 5 or 6 mg\\*min/mL.\n2. Gemcitabine 1000 or 1250 mg/m\\^2 and cisplatin 75 or 80 mg/m\\^2. Additional dose of gemcitabine 1000 or 1250 mg/m\\^2 on Day 8 of each cycle (For squamous participants only).\n3. Gemcitabine 1000 or 1250 mg/m\\^2 and carboplatin AUC 5 or 6 mg\\*min/mL. Additional dose of gemcitabine 1000 or 1250 mg/m\\^2 on Day 8 of each cycle (For squamous participants only).\n4. Pemetrexed 500 mg/m\\^2 and cisplatin 75 mg/m\\^2 (For non-squamous participants only; pemetrexed maintenance dose was permitted).\n5. Pemetrexed 500 mg/m\\^2 and carboplatin AUC 5 or 6 mg\\*min/mL (For non-squamous participants only; pemetrexed maintenance dose was permitted).'}, {'id': 'OG002', 'title': 'China: Durvalumab + Tremelimumab', 'description': 'Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.'}, {'id': 'OG003', 'title': 'China: SoC Chemotherapy', 'description': 'Participants received 1 of the following IV infusion treatment combinations on Day 1 of each 21-day cycle for 4 to 6 cycles or until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.\n\n1. Paclitaxel 200 mg/m\\^2 and carboplatin AUC 5 or 6 mg\\*min/mL.\n2. Gemcitabine 1000 or 1250 mg/m\\^2 and cisplatin 75 or 80 mg/m\\^2. Additional dose of gemcitabine 1000 or 1250 mg/m\\^2 on Day 8 of each cycle (For squamous participants only).\n3. Gemcitabine 1000 or 1250 mg/m\\^2 and carboplatin AUC 5 or 6 mg\\*min/mL. Additional dose of gemcitabine 1000 or 1250 mg/m\\^2 on Day 8 of each cycle (For squamous participants only).\n4. Pemetrexed 500 mg/m\\^2 and cisplatin 75 mg/m\\^2 (For non-squamous participants only; pemetrexed maintenance dose was permitted).\n5. Pemetrexed 500 mg/m\\^2 and carboplatin AUC 5 or 6 mg\\*min/mL (For non-squamous participants only; pemetrexed maintenance dose was permitted).'}], 'classes': [{'title': 'PD-L1-negative NSCLC analysis set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '23.1', 'groupId': 'OG000'}, {'value': '38.8', 'groupId': 'OG001'}, {'value': '23.1', 'groupId': 'OG002'}, {'value': '41.4', 'groupId': 'OG003'}]}]}, {'title': 'FAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '410', 'groupId': 'OG000'}, {'value': '412', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '82', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '25.9', 'groupId': 'OG000'}, {'value': '41.7', 'groupId': 'OG001'}, {'value': '35.9', 'groupId': 'OG002'}, {'value': '39.0', 'groupId': 'OG003'}]}]}, {'title': 'PD-L1 TC ≥25% analysis set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '35.2', 'groupId': 'OG000'}, {'value': '43.9', 'groupId': 'OG001'}, {'value': '54.8', 'groupId': 'OG002'}, {'value': '40.6', 'groupId': 'OG003'}]}]}, {'title': 'PD-L1 TC ≥50% analysis set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '37.4', 'groupId': 'OG000'}, {'value': '44.0', 'groupId': 'OG001'}, {'value': '60.0', 'groupId': 'OG002'}, {'value': '46.4', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.47', 'ciLowerLimit': '0.245', 'ciUpperLimit': '0.869', 'estimateComment': 'The analysis was performed using logistic regression, adjusting for smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with 95% CI calculated by profile likelihood.', 'groupDescription': 'PD-L1-negative analysis set:\n\nGlobal: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy\n\nAn odds ratio \\>1 favors Durvalumab + Tremelimumab combination therapy over SoC.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.42', 'ciLowerLimit': '0.124', 'ciUpperLimit': '1.337', 'groupDescription': 'PD-L1-negative analysis set:\n\nChina: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy\n\nAn odds ratio \\>1 favors Durvalumab + Tremelimumab combination therapy over SoC.', 'statisticalMethod': 'Binomial exact test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.48', 'ciLowerLimit': '0.356', 'ciUpperLimit': '0.647', 'estimateComment': 'The analysis was performed using logistic regression adjusting for PD-L1 status (≥25% Vs \\<25%), smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with 95% CI calculated by profile likelihood.', 'groupDescription': 'FAS:\n\nGlobal: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy\n\nAn odds ratio \\>1 favors Durvalumab + Tremelimumab combination therapy over SoC.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.87', 'ciLowerLimit': '0.450', 'ciUpperLimit': '1.660', 'estimateComment': 'The analysis was performed using logistic regression, adjusting for PD-L1 status (\\>= 25% Vs \\< 25%), smoking status (never smoker Va ever smoker) and histology (squamous Vs non-squamous), with 95% CI calculated by profile likelihood.', 'groupDescription': 'FAS:\n\nChina: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy\n\nAn odds ratio \\>1 favors Durvalumab + Tremelimumab combination therapy over SoC.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.69', 'ciLowerLimit': '0.443', 'ciUpperLimit': '1.079', 'estimateComment': 'The analysis was performed using logistic regression, adjusting for smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with 95% CI calculated by profile likelihood.', 'groupDescription': 'PD-L1 TC ≥25% analysis set:\n\nGlobal: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy\n\nAn odds ratio \\>1 favors Durvalumab + Tremelimumab combination therapy over SoC.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.78', 'ciLowerLimit': '0.658', 'ciUpperLimit': '4.919', 'estimateComment': 'The analysis was performed using logistic regression, adjusting for PD-L1 status (\\>= 25% Vs \\< 25%), smoking status (never smoker Va ever smoker) and histology (squamous Vs non-squamous), with 95% CI calculated by profile likelihood.', 'groupDescription': 'PD-L1 TC ≥ 25% analysis set:\n\nChina: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy\n\nAn odds ratio \\>1 favors Durvalumab + Tremelimumab combination therapy over SoC.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.76', 'ciLowerLimit': '0.449', 'ciUpperLimit': '1.291', 'estimateComment': 'The analysis was performed using logistic regression, adjusting for smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with 95% CI calculated by profile likelihood.', 'groupDescription': 'PD-L1 TC ≥50% analysis set:\n\nGlobal: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy\n\nAn odds ratio \\>1 favors Durvalumab + Tremelimumab combination therapy over SoC.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.73', 'ciLowerLimit': '0.585', 'ciUpperLimit': '5.270', 'estimateComment': 'The analysis was performed using logistic regression, adjusting for PD-L1 status (\\>= 25% Vs \\< 25%), smoking status (never smoker Va ever smoker) and histology (squamous Vs non-squamous), with 95% CI calculated by profile likelihood.', 'groupDescription': 'PD-L1 TC ≥50% analysis set:\n\nChina: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy\n\nAn odds ratio \\>1 favors Durvalumab + Tremelimumab combination therapy over SoC.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.'}], 'paramType': 'NUMBER', 'timeFrame': 'Tumour scans performed at baseline and every 6 weeks up to 48 weeks relative to date of randomization, then every 8 weeks thereafter until confirmed PD/death. Up to Global or China cohort DCO dates, as applicable (approximately 44 months) for each cohort.', 'description': 'The ORR (per RECIST 1.1 using Investigator assessments) was defined as the percentage of participants with at least 1 visit response of CR or PR prior to PD.\n\nPD-L1-negative analysis set included the subset of participants in FAS whose PD-L1 status was PD-L1-negative at baseline as defined by the Ventana SP263 PD-L1 Assay (ie, \\<1% PD-L1-membrane expression in tumoral tissue).\n\nGlobal Cohort: The FAS included all randomized participants prior to the end of global recruitment.\n\nChina Cohort: The China FAS included all randomized participants in the China cohort and were used for all China only efficacy analyses.\n\nPD-L1 TC ≥25% and PD-L1 TC ≥50% analysis sets included the subset of participants in the FAS whose PD-L1 status was TC ≥25% and TC ≥50% membrane expression in tumoral tissue, respectively at baseline as defined by the Ventana SP263 PD-L1 Assay.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants included in PD-L1-negative NSCLC, FAS, PD-L1 TC ≥25%, and PD-L1 TC ≥50% analysis sets with measurable disease are reported in this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DoR); Global Cohort: bTMB ≥20 Mut/Mb, bTMB ≥16 Mut/Mb, and bTMB ≥12 Mut/Mb Analysis Sets', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Global: Durvalumab + Tremelimumab', 'description': 'Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.'}, {'id': 'OG001', 'title': 'Global: SoC Chemotherapy', 'description': 'Participants received 1 of the following IV infusion treatment combinations on Day 1 of each 21-day cycle for 4 to 6 cycles or until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.\n\n1. Paclitaxel 200 mg/m\\^2 and carboplatin AUC 5 or 6 mg\\*min/mL.\n2. Gemcitabine 1000 or 1250 mg/m\\^2 and cisplatin 75 or 80 mg/m\\^2. Additional dose of gemcitabine 1000 or 1250 mg/m\\^2 on Day 8 of each cycle (For squamous participants only).\n3. Gemcitabine 1000 or 1250 mg/m\\^2 and carboplatin AUC 5 or 6 mg\\*min/mL. Additional dose of gemcitabine 1000 or 1250 mg/m\\^2 on Day 8 of each cycle (For squamous participants only).\n4. Pemetrexed 500 mg/m\\^2 and cisplatin 75 mg/m\\^2 (For non-squamous participants only; pemetrexed maintenance dose was permitted).\n5. Pemetrexed 500 mg/m\\^2 and carboplatin AUC 5 or 6 mg\\*min/mL (For non-squamous participants only; pemetrexed maintenance dose was permitted).'}], 'classes': [{'title': 'bTMB ≥20 mut/Mb analysis set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.6', 'groupId': 'OG000', 'lowerLimit': '6.7', 'upperLimit': '21.5'}, {'value': '4.2', 'groupId': 'OG001', 'lowerLimit': '3.0', 'upperLimit': '6.9'}]}]}, {'title': 'bTMB ≥16 mut/Mb analysis set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.6', 'groupId': 'OG000', 'lowerLimit': '4.2', 'upperLimit': '21.5'}, {'value': '4.3', 'groupId': 'OG001', 'lowerLimit': '3.0', 'upperLimit': '5.9'}]}]}, {'title': 'bTMB ≥12 mut/Mb analysis set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.5', 'groupId': 'OG000', 'lowerLimit': '6.7', 'upperLimit': '18.8'}, {'value': '4.3', 'groupId': 'OG001', 'lowerLimit': '3.0', 'upperLimit': '5.6'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.25', 'ciLowerLimit': '0.113', 'ciUpperLimit': '0.532', 'estimateComment': 'The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.', 'groupDescription': 'bTMB ≥20 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy\n\nA HR \\<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer DoR than SoC.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.36', 'ciLowerLimit': '0.196', 'ciUpperLimit': '0.639', 'estimateComment': 'The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.', 'groupDescription': 'bTMB ≥16 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy\n\nA HR \\<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer DoR than SoC.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.38', 'ciLowerLimit': '0.233', 'ciUpperLimit': '0.611', 'estimateComment': 'The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.', 'groupDescription': 'bTMB ≥12 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy\n\nA HR \\<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer DoR than SoC.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Tumour scans performed at baseline and every 6 weeks up to 48 weeks relative to date of randomization, then every 8 weeks thereafter until confirmed PD/death. Up to Global cohort DCO date (approximately 44 months).', 'description': 'DoR (per RECIST 1.1 using Investigator assessments) was defined as the time from the date of first documented response (CR or PR) until the first date of documented progression or death in the absence of PD (ie, date of PFS event or censoring - date of first response + 1).\n\nbTMB ≥20 mut/Mb, bTMB ≥16 mut/Mb and bTMB ≥12 mut/Mb analysis sets included the subset of participants in FAS whose bTMB status was ≥20 mut/Mb, ≥16 mut/Mb and ≥12 mut/Mb, respectively at baseline as defined by the GuardantOMNI CDx assay.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants included in bTMB ≥20 mut/Mb, bTMB ≥16 mut/Mb, and bTMB ≥12 mut/Mb analysis sets are reported in this outcome measure. Only participants with objective response and randomized in Global cohort were analyzed as bTMB and tTMB testing was not performed in China cohort.'}, {'type': 'SECONDARY', 'title': 'DoR; Global and China Cohorts: PD-L1-Negative NSCLC and FAS Analysis Sets', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Global: Durvalumab + Tremelimumab', 'description': 'Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.'}, {'id': 'OG001', 'title': 'Global: SoC Chemotherapy', 'description': 'Participants received 1 of the following IV infusion treatment combinations on Day 1 of each 21-day cycle for 4 to 6 cycles or until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.\n\n1. Paclitaxel 200 mg/m\\^2 and carboplatin AUC 5 or 6 mg\\*min/mL.\n2. Gemcitabine 1000 or 1250 mg/m\\^2 and cisplatin 75 or 80 mg/m\\^2. Additional dose of gemcitabine 1000 or 1250 mg/m\\^2 on Day 8 of each cycle (For squamous participants only).\n3. Gemcitabine 1000 or 1250 mg/m\\^2 and carboplatin AUC 5 or 6 mg\\*min/mL. Additional dose of gemcitabine 1000 or 1250 mg/m\\^2 on Day 8 of each cycle (For squamous participants only).\n4. Pemetrexed 500 mg/m\\^2 and cisplatin 75 mg/m\\^2 (For non-squamous participants only; pemetrexed maintenance dose was permitted).\n5. Pemetrexed 500 mg/m\\^2 and carboplatin AUC 5 or 6 mg\\*min/mL (For non-squamous participants only; pemetrexed maintenance dose was permitted).'}, {'id': 'OG002', 'title': 'China: Durvalumab + Tremelimumab', 'description': 'Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.'}, {'id': 'OG003', 'title': 'China: SoC Chemotherapy', 'description': 'Participants received 1 of the following IV infusion treatment combinations on Day 1 of each 21-day cycle for 4 to 6 cycles or until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.\n\n1. Paclitaxel 200 mg/m\\^2 and carboplatin AUC 5 or 6 mg\\*min/mL.\n2. Gemcitabine 1000 or 1250 mg/m\\^2 and cisplatin 75 or 80 mg/m\\^2. Additional dose of gemcitabine 1000 or 1250 mg/m\\^2 on Day 8 of each cycle (For squamous participants only).\n3. Gemcitabine 1000 or 1250 mg/m\\^2 and carboplatin AUC 5 or 6 mg\\*min/mL. Additional dose of gemcitabine 1000 or 1250 mg/m\\^2 on Day 8 of each cycle (For squamous participants only).\n4. Pemetrexed 500 mg/m\\^2 and cisplatin 75 mg/m\\^2 (For non-squamous participants only; pemetrexed maintenance dose was permitted).\n5. Pemetrexed 500 mg/m\\^2 and carboplatin AUC 5 or 6 mg\\*min/mL (For non-squamous participants only; pemetrexed maintenance dose was permitted).'}], 'classes': [{'title': 'PD-L1-negative NSCLC analysis set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10.2', 'groupId': 'OG000', 'lowerLimit': '2.8', 'upperLimit': '18.8'}, {'value': '4.9', 'groupId': 'OG001', 'lowerLimit': '4.2', 'upperLimit': '6.1'}, {'value': '10.5', 'comment': 'Upper limit was not reached.', 'groupId': 'OG002', 'lowerLimit': '1.4', 'upperLimit': 'NA'}, {'value': '6.1', 'groupId': 'OG003', 'lowerLimit': '3.0', 'upperLimit': '11.7'}]}]}, {'title': 'FAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '11.1', 'groupId': 'OG000', 'lowerLimit': '6.9', 'upperLimit': '15.2'}, {'value': '4.9', 'groupId': 'OG001', 'lowerLimit': '4.2', 'upperLimit': '5.6'}, {'value': '12.9', 'groupId': 'OG002', 'lowerLimit': '5.4', 'upperLimit': '33.6'}, {'value': '6.1', 'groupId': 'OG003', 'lowerLimit': '4.4', 'upperLimit': '7.2'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.41', 'ciLowerLimit': '0.199', 'ciUpperLimit': '0.787', 'estimateComment': 'The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with ties handled by the Efron approach.', 'groupDescription': 'PD-L1-negative analysis set:\n\nGlobal: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy\n\nA HR \\<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer DoR than SoC.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.79', 'ciLowerLimit': '0.183', 'ciUpperLimit': '2.860', 'estimateComment': 'The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Efron approach.', 'groupDescription': 'PD-L1-negative analysis set:\n\nChina: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy\n\nA HR \\<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer DoR than SoC.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.44', 'ciLowerLimit': '0.324', 'ciUpperLimit': '0.588', 'estimateComment': 'The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.', 'groupDescription': 'FAS:\n\nGlobal: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy\n\nA HR \\<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer DoR than SoC.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.39', 'ciLowerLimit': '0.193', 'ciUpperLimit': '0.761', 'estimateComment': 'The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\\>= 25% Vs \\< 25%) and histology (squamous Vs non-squamous), with ties handled by the Efron approach.', 'groupDescription': 'FAS:\n\nChina: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy\n\nA HR \\<1 favors Durvalumab + Tremelimumab combination therapy to be associated with a longer DoR than SoC.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Tumour scans performed at baseline and every 6 weeks up to 48 weeks relative to date of randomization, then every 8 weeks thereafter until confirmed PD/death. Up to Global or China cohort DCO dates, as applicable (approximately 44 months) for each cohort.', 'description': 'DoR (per RECIST 1.1 using Investigator assessments) was defined as the time from the date of first documented response (CR or PR) until the first date of documented progression or death in the absence of PD (ie, date of PFS event or censoring - date of first response + 1).\n\nPD-L1-negative analysis set included the subset of participants in FAS whose PD-L1 status was PD-L1-negative at baseline as defined by the Ventana SP263 PD-L1 Assay (ie, \\<1% PD-L1-membrane expression in tumoral tissue).\n\nGlobal Cohort: The FAS included all randomized participants prior to the end of global recruitment.\n\nChina Cohort: The China FAS included all randomized participants in the China cohort and were used for all China only efficacy analyses.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants included in PD-L1-negative NSCLC and FAS analysis sets are reported in this outcome measure. Only participants with objective response were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Alive and Progression-Free at 12 Months (APF12); Global Cohort: bTMB ≥20 Mut/Mb, bTMB ≥16 Mut/Mb, and bTMB ≥12 Mut/Mb Analysis Sets', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Global: Durvalumab + Tremelimumab', 'description': 'Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.'}, {'id': 'OG001', 'title': 'Global: SoC Chemotherapy', 'description': 'Participants received 1 of the following IV infusion treatment combinations on Day 1 of each 21-day cycle for 4 to 6 cycles or until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.\n\n1. Paclitaxel 200 mg/m\\^2 and carboplatin AUC 5 or 6 mg\\*min/mL.\n2. Gemcitabine 1000 or 1250 mg/m\\^2 and cisplatin 75 or 80 mg/m\\^2. Additional dose of gemcitabine 1000 or 1250 mg/m\\^2 on Day 8 of each cycle (For squamous participants only).\n3. Gemcitabine 1000 or 1250 mg/m\\^2 and carboplatin AUC 5 or 6 mg\\*min/mL. Additional dose of gemcitabine 1000 or 1250 mg/m\\^2 on Day 8 of each cycle (For squamous participants only).\n4. Pemetrexed 500 mg/m\\^2 and cisplatin 75 mg/m\\^2 (For non-squamous participants only; pemetrexed maintenance dose was permitted).\n5. Pemetrexed 500 mg/m\\^2 and carboplatin AUC 5 or 6 mg\\*min/mL (For non-squamous participants only; pemetrexed maintenance dose was permitted).'}], 'classes': [{'title': 'bTMB ≥20 mut/Mb analysis set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.6', 'groupId': 'OG000', 'lowerLimit': '15.7', 'upperLimit': '36.6'}, {'value': '7.0', 'groupId': 'OG001', 'lowerLimit': '1.9', 'upperLimit': '16.8'}]}]}, {'title': 'bTMB ≥16 mut/Mb analysis set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.0', 'groupId': 'OG000', 'lowerLimit': '14.1', 'upperLimit': '31.1'}, {'value': '12.3', 'groupId': 'OG001', 'lowerLimit': '6.1', 'upperLimit': '20.8'}]}]}, {'title': 'bTMB ≥12 mut/Mb analysis set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.6', 'groupId': 'OG000', 'lowerLimit': '15.2', 'upperLimit': '28.9'}, {'value': '13.8', 'groupId': 'OG001', 'lowerLimit': '8.3', 'upperLimit': '20.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Tumour scans performed at baseline then every 6 weeks up to 12 months.', 'description': 'The APF12 was defined as the percentage of participants who were alive and progression free at 12 months from randomization (ie, PFS rate at 12 months).\n\nbTMB ≥20 mut/Mb, bTMB ≥16 mut/Mb and bTMB ≥12 mut/Mb analysis sets included the subset of participants in FAS whose bTMB status was ≥20 mut/Mb, ≥16 mut/Mb and ≥12 mut/Mb, respectively at baseline as defined by the GuardantOMNI CDx assay.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants included in bTMB ≥20 mut/Mb, bTMB ≥16 mut/Mb, and bTMB ≥12 mut/Mb analysis sets are reported in this outcome measure. Only participants randomized in Global cohort were analyzed as bTMB and tTMB testing was not performed in China cohort.'}, {'type': 'SECONDARY', 'title': 'APF12; Global and China Cohorts: PD-L1-Negative NSCLC and FAS Analysis Sets', 'denoms': [{'units': 'Participants', 'counts': [{'value': '410', 'groupId': 'OG000'}, {'value': '413', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '82', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Global: Durvalumab + Tremelimumab', 'description': 'Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.'}, {'id': 'OG001', 'title': 'Global: SoC Chemotherapy', 'description': 'Participants received 1 of the following IV infusion treatment combinations on Day 1 of each 21-day cycle for 4 to 6 cycles or until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.\n\n1. Paclitaxel 200 mg/m\\^2 and carboplatin AUC 5 or 6 mg\\*min/mL.\n2. Gemcitabine 1000 or 1250 mg/m\\^2 and cisplatin 75 or 80 mg/m\\^2. Additional dose of gemcitabine 1000 or 1250 mg/m\\^2 on Day 8 of each cycle (For squamous participants only).\n3. Gemcitabine 1000 or 1250 mg/m\\^2 and carboplatin AUC 5 or 6 mg\\*min/mL. Additional dose of gemcitabine 1000 or 1250 mg/m\\^2 on Day 8 of each cycle (For squamous participants only).\n4. Pemetrexed 500 mg/m\\^2 and cisplatin 75 mg/m\\^2 (For non-squamous participants only; pemetrexed maintenance dose was permitted).\n5. Pemetrexed 500 mg/m\\^2 and carboplatin AUC 5 or 6 mg\\*min/mL (For non-squamous participants only; pemetrexed maintenance dose was permitted).'}, {'id': 'OG002', 'title': 'China: Durvalumab + Tremelimumab', 'description': 'Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.'}, {'id': 'OG003', 'title': 'China: SoC Chemotherapy', 'description': 'Participants received 1 of the following IV infusion treatment combinations on Day 1 of each 21-day cycle for 4 to 6 cycles or until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.\n\n1. Paclitaxel 200 mg/m\\^2 and carboplatin AUC 5 or 6 mg\\*min/mL.\n2. Gemcitabine 1000 or 1250 mg/m\\^2 and cisplatin 75 or 80 mg/m\\^2. Additional dose of gemcitabine 1000 or 1250 mg/m\\^2 on Day 8 of each cycle (For squamous participants only).\n3. Gemcitabine 1000 or 1250 mg/m\\^2 and carboplatin AUC 5 or 6 mg\\*min/mL. Additional dose of gemcitabine 1000 or 1250 mg/m\\^2 on Day 8 of each cycle (For squamous participants only).\n4. Pemetrexed 500 mg/m\\^2 and cisplatin 75 mg/m\\^2 (For non-squamous participants only; pemetrexed maintenance dose was permitted).\n5. Pemetrexed 500 mg/m\\^2 and carboplatin AUC 5 or 6 mg\\*min/mL (For non-squamous participants only; pemetrexed maintenance dose was permitted).'}], 'classes': [{'title': 'PD-L1-negative NSCLC analysis set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '18.2', 'groupId': 'OG000', 'lowerLimit': '10.9', 'upperLimit': '26.9'}, {'value': '12.1', 'groupId': 'OG001', 'lowerLimit': '6.3', 'upperLimit': '19.9'}, {'value': '15.6', 'groupId': 'OG002', 'lowerLimit': '4.0', 'upperLimit': '34.4'}, {'value': '11.3', 'groupId': 'OG003', 'lowerLimit': '2.3', 'upperLimit': '28.5'}]}]}, {'title': 'FAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '410', 'groupId': 'OG000'}, {'value': '413', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '82', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '20.2', 'groupId': 'OG000', 'lowerLimit': '16.4', 'upperLimit': '24.3'}, {'value': '14.9', 'groupId': 'OG001', 'lowerLimit': '11.4', 'upperLimit': '18.9'}, {'value': '23.9', 'groupId': 'OG002', 'lowerLimit': '14.8', 'upperLimit': '34.2'}, {'value': '16.6', 'groupId': 'OG003', 'lowerLimit': '8.5', 'upperLimit': '27.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Tumour scans performed at baseline then every 6 weeks up to 12 months.', 'description': 'The APF12 was defined as the percentage of patients who were alive and progression free at 12 months from randomization (ie, PFS rate at 12 months).\n\nPD-L1-negative analysis set included the subset of participants in FAS whose PD-L1 status was PD-L1-negative at baseline as defined by the Ventana SP263 PD-L1 Assay (ie, \\<1% PD-L1-membrane expression in tumoral tissue).\n\nGlobal Cohort: The FAS included all randomized participants prior to the end of global recruitment.\n\nChina Cohort: The China FAS included all randomized participants in the China cohort and were used for all China only efficacy analyses.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants included in PD-L1-negative NSCLC and FAS analysis sets are reported in this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Time From Randomization to Second Progression or Death (PFS2); Global Cohort: bTMB ≥20 Mut/Mb, bTMB ≥16 Mut/Mb, and bTMB ≥12 Mut/Mb Analysis Sets', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Global: Durvalumab + Tremelimumab', 'description': 'Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.'}, {'id': 'OG001', 'title': 'Global: SoC Chemotherapy', 'description': 'Participants received 1 of the following IV infusion treatment combinations on Day 1 of each 21-day cycle for 4 to 6 cycles or until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.\n\n1. Paclitaxel 200 mg/m\\^2 and carboplatin AUC 5 or 6 mg\\*min/mL.\n2. Gemcitabine 1000 or 1250 mg/m\\^2 and cisplatin 75 or 80 mg/m\\^2. Additional dose of gemcitabine 1000 or 1250 mg/m\\^2 on Day 8 of each cycle (For squamous participants only).\n3. Gemcitabine 1000 or 1250 mg/m\\^2 and carboplatin AUC 5 or 6 mg\\*min/mL. Additional dose of gemcitabine 1000 or 1250 mg/m\\^2 on Day 8 of each cycle (For squamous participants only).\n4. Pemetrexed 500 mg/m\\^2 and cisplatin 75 mg/m\\^2 (For non-squamous participants only; pemetrexed maintenance dose was permitted).\n5. Pemetrexed 500 mg/m\\^2 and carboplatin AUC 5 or 6 mg\\*min/mL (For non-squamous participants only; pemetrexed maintenance dose was permitted).'}], 'classes': [{'title': 'bTMB ≥20 mut/Mb analysis set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.6', 'groupId': 'OG000', 'lowerLimit': '8.5', 'upperLimit': '14.4'}, {'value': '8.6', 'groupId': 'OG001', 'lowerLimit': '7.3', 'upperLimit': '12.6'}]}]}, {'title': 'bTMB ≥16 mut/Mb analysis set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.9', 'groupId': 'OG000', 'lowerLimit': '8.5', 'upperLimit': '14.1'}, {'value': '10.5', 'groupId': 'OG001', 'lowerLimit': '8.0', 'upperLimit': '13.2'}]}]}, {'title': 'bTMB ≥12 mut/Mb analysis set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.9', 'groupId': 'OG000', 'lowerLimit': '8.2', 'upperLimit': '11.7'}, {'value': '9.0', 'groupId': 'OG001', 'lowerLimit': '7.8', 'upperLimit': '10.8'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.72', 'ciLowerLimit': '0.494', 'ciUpperLimit': '1.058', 'estimateComment': 'The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.', 'groupDescription': 'bTMB ≥20 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy\n\nA HR \\<1 favors Durvalumab + Tremelimumab to be associated with a longer time to second progression than SoC.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.84', 'ciLowerLimit': '0.607', 'ciUpperLimit': '1.151', 'estimateComment': 'The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.', 'groupDescription': 'bTMB ≥16 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy\n\nA HR \\<1 favors Durvalumab + Tremelimumab to be associated with a longer time to second progression than SoC.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.89', 'ciLowerLimit': '0.689', 'ciUpperLimit': '1.146', 'estimateComment': 'The HR and CI were calculated using an unstratified Cox proportional hazards model, with ties handled by the Efron approach.', 'groupDescription': 'bTMB ≥12 mut/Mb analysis set: Global: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy\n\nA HR \\<1 favors Durvalumab + Tremelimumab to be associated with a longer time to second progression than SoC.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Tumour scans performed at baseline and every 6 weeks up to 48 weeks relative to date of randomization, then every 8 weeks thereafter until confirmed PD/death. Up to Global cohort DCO date (approximately 44 months).', 'description': 'The PFS2 was defined as the time from the date of randomization to the earliest of the progression events subsequent to that used for the primary variable PFS, or death (ie, date of PFS2 event or censoring - date of randomization + 1).\n\nbTMB ≥20 mut/Mb, bTMB ≥16 mut/Mb and bTMB ≥12 mut/Mb analysis sets included the subset of participants in FAS whose bTMB status was ≥20 mut/Mb, ≥16 mut/Mb and ≥12 mut/Mb, respectively at baseline as defined by the GuardantOMNI CDx assay.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants included in bTMB ≥20 mut/Mb, bTMB ≥16 mut/Mb, and bTMB ≥12 mut/Mb analysis sets are reported in this outcome measure. Only participants randomized in Global cohort were analyzed as bTMB and tTMB testing was not performed in China cohort.'}, {'type': 'SECONDARY', 'title': 'PFS2; Global and China Cohorts: PD-L1-Negative NSCLC and FAS Analysis Sets', 'denoms': [{'units': 'Participants', 'counts': [{'value': '410', 'groupId': 'OG000'}, {'value': '413', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '82', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Global: Durvalumab + Tremelimumab', 'description': 'Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.'}, {'id': 'OG001', 'title': 'Global: SoC Chemotherapy', 'description': 'Participants received 1 of the following IV infusion treatment combinations on Day 1 of each 21-day cycle for 4 to 6 cycles or until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.\n\n1. Paclitaxel 200 mg/m\\^2 and carboplatin AUC 5 or 6 mg\\*min/mL.\n2. Gemcitabine 1000 or 1250 mg/m\\^2 and cisplatin 75 or 80 mg/m\\^2. Additional dose of gemcitabine 1000 or 1250 mg/m\\^2 on Day 8 of each cycle (For squamous participants only).\n3. Gemcitabine 1000 or 1250 mg/m\\^2 and carboplatin AUC 5 or 6 mg\\*min/mL. Additional dose of gemcitabine 1000 or 1250 mg/m\\^2 on Day 8 of each cycle (For squamous participants only).\n4. Pemetrexed 500 mg/m\\^2 and cisplatin 75 mg/m\\^2 (For non-squamous participants only; pemetrexed maintenance dose was permitted).\n5. Pemetrexed 500 mg/m\\^2 and carboplatin AUC 5 or 6 mg\\*min/mL (For non-squamous participants only; pemetrexed maintenance dose was permitted).'}, {'id': 'OG002', 'title': 'China: Durvalumab + Tremelimumab', 'description': 'Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.'}, {'id': 'OG003', 'title': 'China: SoC Chemotherapy', 'description': 'Participants received 1 of the following IV infusion treatment combinations on Day 1 of each 21-day cycle for 4 to 6 cycles or until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.\n\n1. Paclitaxel 200 mg/m\\^2 and carboplatin AUC 5 or 6 mg\\*min/mL.\n2. Gemcitabine 1000 or 1250 mg/m\\^2 and cisplatin 75 or 80 mg/m\\^2. Additional dose of gemcitabine 1000 or 1250 mg/m\\^2 on Day 8 of each cycle (For squamous participants only).\n3. Gemcitabine 1000 or 1250 mg/m\\^2 and carboplatin AUC 5 or 6 mg\\*min/mL. Additional dose of gemcitabine 1000 or 1250 mg/m\\^2 on Day 8 of each cycle (For squamous participants only).\n4. Pemetrexed 500 mg/m\\^2 and cisplatin 75 mg/m\\^2 (For non-squamous participants only; pemetrexed maintenance dose was permitted).\n5. Pemetrexed 500 mg/m\\^2 and carboplatin AUC 5 or 6 mg\\*min/mL (For non-squamous participants only; pemetrexed maintenance dose was permitted).'}], 'classes': [{'title': 'PD-L1-negative NSCLC analysis set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '9.1', 'groupId': 'OG000', 'lowerLimit': '6.9', 'upperLimit': '12.8'}, {'value': '12.4', 'groupId': 'OG001', 'lowerLimit': '8.8', 'upperLimit': '14.9'}, {'value': '13.8', 'groupId': 'OG002', 'lowerLimit': '10.1', 'upperLimit': '27.4'}, {'value': '10.3', 'groupId': 'OG003', 'lowerLimit': '6.5', 'upperLimit': '14.1'}]}]}, {'title': 'FAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '410', 'groupId': 'OG000'}, {'value': '413', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '82', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '9.4', 'groupId': 'OG000', 'lowerLimit': '8.2', 'upperLimit': '10.9'}, {'value': '10.4', 'groupId': 'OG001', 'lowerLimit': '9.1', 'upperLimit': '11.5'}, {'value': '15.5', 'groupId': 'OG002', 'lowerLimit': '12.5', 'upperLimit': '24.5'}, {'value': '12.9', 'groupId': 'OG003', 'lowerLimit': '9.2', 'upperLimit': '15.4'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.02', 'ciLowerLimit': '0.748', 'ciUpperLimit': '1.388', 'estimateComment': 'The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with ties handled by the Efron approach.', 'groupDescription': 'PD-L1-negative analysis set:\n\nGlobal: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy\n\nA HR \\<1 favors Durvalumab + Tremelimumab to be associated with a longer time to second progression than SoC.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.67', 'ciLowerLimit': '0.360', 'ciUpperLimit': '1.219', 'estimateComment': 'The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Efron approach.', 'groupDescription': 'PD-L1-negative analysis set:\n\nChina: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy\n\nA HR \\<1 favors Durvalumab + Tremelimumab to be associated with a longer time to second progression than SoC.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.845', 'ciUpperLimit': '1.147', 'estimateComment': 'The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status (\\>= 25% Vs \\< 25%), smoking status (never smoker Vs ever smoker) and histology (squamous Vs non-squamous), with ties handled by Efron approach.', 'groupDescription': 'FAS:\n\nGlobal: Durvalumab + Tremelimumab Vs Global: SoC Chemotherapy\n\nA HR \\<1 favors Durvalumab + Tremelimumab to be associated with a longer time to second progression than SoC.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.71', 'ciLowerLimit': '0.492', 'ciUpperLimit': '1.030', 'estimateComment': 'The HR and CI were calculated using a stratified Cox proportional hazards model, adjusting for histology (squamous Vs non-squamous), with ties handled by the Efron approach.', 'groupDescription': 'FAS:\n\nChina: Durvalumab + Tremelimumab Vs China: SoC Chemotherapy\n\nA HR \\<1 favors Durvalumab + Tremelimumab to be associated with a longer time to second progression than SoC.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The study was not designed or powered to show statistical significance for efficacy endpoints in the China cohort, so all statistical analyses for the China cohort were considered exploratory.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Tumour scans performed at baseline and every 6 weeks up to 48 weeks relative to date of randomization, then every 8 weeks thereafter until confirmed PD/death. Up to Global or China cohort DCO dates, as applicable (approximately 44 months) for each cohort.', 'description': 'The PFS2 was defined as the time from the date of randomization to the earliest of the progression events subsequent to that used for the primary variable PFS, or death (ie, date of PFS2 event or censoring - date of randomization + 1).\n\nPD-L1-negative analysis set included the subset of participants in FAS whose PD-L1 status was PD-L1-negative at baseline as defined by the Ventana SP263 PD-L1 Assay (ie, \\<1% PD-L1-membrane expression in tumoral tissue).\n\nGlobal Cohort: The FAS included all randomized participants prior to the end of global recruitment.\n\nChina Cohort: The China FAS included all randomized participants in the China cohort and were used for all China only efficacy analyses.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants included in PD-L1-negative NSCLC and FAS analysis sets are reported in this outcome measure.'}, {'type': 'SECONDARY', 'title': 'OS at Months 12, 18 and 24; Global Cohort: bTMB ≥20 Mut/Mb, bTMB ≥16 Mut/Mb, and bTMB ≥12 Mut/Mb Analysis Sets', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Global: Durvalumab + Tremelimumab', 'description': 'Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.'}, {'id': 'OG001', 'title': 'Global: SoC Chemotherapy', 'description': 'Participants received 1 of the following IV infusion treatment combinations on Day 1 of each 21-day cycle for 4 to 6 cycles or until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.\n\n1. Paclitaxel 200 mg/m\\^2 and carboplatin AUC 5 or 6 mg\\*min/mL.\n2. Gemcitabine 1000 or 1250 mg/m\\^2 and cisplatin 75 or 80 mg/m\\^2. Additional dose of gemcitabine 1000 or 1250 mg/m\\^2 on Day 8 of each cycle (For squamous participants only).\n3. Gemcitabine 1000 or 1250 mg/m\\^2 and carboplatin AUC 5 or 6 mg\\*min/mL. Additional dose of gemcitabine 1000 or 1250 mg/m\\^2 on Day 8 of each cycle (For squamous participants only).\n4. Pemetrexed 500 mg/m\\^2 and cisplatin 75 mg/m\\^2 (For non-squamous participants only; pemetrexed maintenance dose was permitted).\n5. Pemetrexed 500 mg/m\\^2 and carboplatin AUC 5 or 6 mg\\*min/mL (For non-squamous participants only; pemetrexed maintenance dose was permitted).'}], 'classes': [{'title': 'Month 12: bTMB ≥20 mut/Mb analysis set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '49.3', 'groupId': 'OG000', 'lowerLimit': '37.1', 'upperLimit': '60.4'}, {'value': '40.8', 'groupId': 'OG001', 'lowerLimit': '28.3', 'upperLimit': '52.9'}]}]}, {'title': 'Month 12: bTMB ≥16 mut/Mb analysis set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50.5', 'groupId': 'OG000', 'lowerLimit': '40.0', 'upperLimit': '60.2'}, {'value': '48.9', 'groupId': 'OG001', 'lowerLimit': '38.2', 'upperLimit': '58.8'}]}]}, {'title': 'Month 12: bTMB ≥12 mut/Mb analysis set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '46.9', 'groupId': 'OG000', 'lowerLimit': '38.5', 'upperLimit': '54.8'}, {'value': '44.6', 'groupId': 'OG001', 'lowerLimit': '36.1', 'upperLimit': '52.7'}]}]}, {'title': 'Month 18: bTMB ≥20 mut/Mb analysis set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36.2', 'groupId': 'OG000', 'lowerLimit': '25.1', 'upperLimit': '47.4'}, {'value': '20.4', 'groupId': 'OG001', 'lowerLimit': '11.3', 'upperLimit': '31.4'}]}]}, {'title': 'Month 18: bTMB ≥16 mut/Mb analysis set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '35.5', 'groupId': 'OG000', 'lowerLimit': '25.9', 'upperLimit': '45.1'}, {'value': '28.5', 'groupId': 'OG001', 'lowerLimit': '19.5', 'upperLimit': '38.1'}]}]}, {'title': 'Month 18: bTMB ≥12 mut/Mb analysis set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29.4', 'groupId': 'OG000', 'lowerLimit': '22.1', 'upperLimit': '36.9'}, {'value': '27.8', 'groupId': 'OG001', 'lowerLimit': '20.6', 'upperLimit': '35.4'}]}]}, {'title': 'Month 24: bTMB ≥20 mut/Mb analysis set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.1', 'groupId': 'OG000', 'lowerLimit': '16.4', 'upperLimit': '36.8'}, {'value': '13.6', 'groupId': 'OG001', 'lowerLimit': '6.4', 'upperLimit': '23.6'}]}]}, {'title': 'Month 24: bTMB ≥16 mut/Mb analysis set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24.0', 'groupId': 'OG000', 'lowerLimit': '15.8', 'upperLimit': '33.2'}, {'value': '18.2', 'groupId': 'OG001', 'lowerLimit': '11.0', 'upperLimit': '26.9'}]}]}, {'title': 'Month 24: bTMB ≥12 mut/Mb analysis set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.3', 'groupId': 'OG000', 'lowerLimit': '15.0', 'upperLimit': '28.4'}, {'value': '19.0', 'groupId': 'OG001', 'lowerLimit': '12.9', 'upperLimit': '26.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Months 12, 18 and 24', 'description': 'The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1).\n\nbTMB ≥20 mut/Mb, bTMB ≥16 mut/Mb and bTMB ≥12 mut/Mb analysis sets included the subset of participants in FAS whose bTMB status was ≥20 mut/Mb, ≥16 mut/Mb and ≥12 mut/Mb, respectively at baseline as defined by the GuardantOMNI CDx assay.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants included in bTMB ≥20 mut/Mb, bTMB ≥16 mut/Mb, and bTMB ≥12 mut/Mb analysis sets are reported in this outcome measure. Only participants randomized in Global cohort were analyzed as bTMB and tTMB testing was not performed in China cohort.'}, {'type': 'SECONDARY', 'title': 'OS at Months 12, 18 and 24; Global and China Cohorts: PD-L1-Negative NSCLC and FAS Analysis Sets', 'denoms': [{'units': 'Participants', 'counts': [{'value': '410', 'groupId': 'OG000'}, {'value': '413', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '82', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Global: Durvalumab + Tremelimumab', 'description': 'Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.'}, {'id': 'OG001', 'title': 'Global: SoC Chemotherapy', 'description': 'Participants received 1 of the following IV infusion treatment combinations on Day 1 of each 21-day cycle for 4 to 6 cycles or until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.\n\n1. Paclitaxel 200 mg/m\\^2 and carboplatin AUC 5 or 6 mg\\*min/mL.\n2. Gemcitabine 1000 or 1250 mg/m\\^2 and cisplatin 75 or 80 mg/m\\^2. Additional dose of gemcitabine 1000 or 1250 mg/m\\^2 on Day 8 of each cycle (For squamous participants only).\n3. Gemcitabine 1000 or 1250 mg/m\\^2 and carboplatin AUC 5 or 6 mg\\*min/mL. Additional dose of gemcitabine 1000 or 1250 mg/m\\^2 on Day 8 of each cycle (For squamous participants only).\n4. Pemetrexed 500 mg/m\\^2 and cisplatin 75 mg/m\\^2 (For non-squamous participants only; pemetrexed maintenance dose was permitted).\n5. Pemetrexed 500 mg/m\\^2 and carboplatin AUC 5 or 6 mg\\*min/mL (For non-squamous participants only; pemetrexed maintenance dose was permitted).'}, {'id': 'OG002', 'title': 'China: Durvalumab + Tremelimumab', 'description': 'Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.'}, {'id': 'OG003', 'title': 'China: SoC Chemotherapy', 'description': 'Participants received 1 of the following IV infusion treatment combinations on Day 1 of each 21-day cycle for 4 to 6 cycles or until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.\n\n1. Paclitaxel 200 mg/m\\^2 and carboplatin AUC 5 or 6 mg\\*min/mL.\n2. Gemcitabine 1000 or 1250 mg/m\\^2 and cisplatin 75 or 80 mg/m\\^2. Additional dose of gemcitabine 1000 or 1250 mg/m\\^2 on Day 8 of each cycle (For squamous participants only).\n3. Gemcitabine 1000 or 1250 mg/m\\^2 and carboplatin AUC 5 or 6 mg\\*min/mL. Additional dose of gemcitabine 1000 or 1250 mg/m\\^2 on Day 8 of each cycle (For squamous participants only).\n4. Pemetrexed 500 mg/m\\^2 and cisplatin 75 mg/m\\^2 (For non-squamous participants only; pemetrexed maintenance dose was permitted).\n5. Pemetrexed 500 mg/m\\^2 and carboplatin AUC 5 or 6 mg\\*min/mL (For non-squamous participants only; pemetrexed maintenance dose was permitted).'}], 'classes': [{'title': 'Month 12: PD-L1-negative NSCLC analysis set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '47.8', 'groupId': 'OG000', 'lowerLimit': '37.2', 'upperLimit': '57.6'}, {'value': '52.8', 'groupId': 'OG001', 'lowerLimit': '42.6', 'upperLimit': '61.9'}, {'value': '68.0', 'groupId': 'OG002', 'lowerLimit': '46.1', 'upperLimit': '82.5'}, {'value': '46.4', 'groupId': 'OG003', 'lowerLimit': '27.6', 'upperLimit': '63.3'}]}]}, {'title': 'Month 12: FAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '410', 'groupId': 'OG000'}, {'value': '413', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '82', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '47.7', 'groupId': 'OG000', 'lowerLimit': '42.8', 'upperLimit': '52.5'}, {'value': '50.0', 'groupId': 'OG001', 'lowerLimit': '45.0', 'upperLimit': '54.8'}, {'value': '72.8', 'groupId': 'OG002', 'lowerLimit': '61.3', 'upperLimit': '81.3'}, {'value': '53.1', 'groupId': 'OG003', 'lowerLimit': '41.7', 'upperLimit': '63.2'}]}]}, {'title': 'Month 18: PD-L1-negative NSCLC analysis set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '34.1', 'groupId': 'OG000', 'lowerLimit': '24.5', 'upperLimit': '43.9'}, {'value': '34.5', 'groupId': 'OG001', 'lowerLimit': '25.4', 'upperLimit': '43.8'}, {'value': '44.0', 'groupId': 'OG002', 'lowerLimit': '24.5', 'upperLimit': '61.9'}, {'value': '39.3', 'groupId': 'OG003', 'lowerLimit': '21.7', 'upperLimit': '56.5'}]}]}, {'title': 'Month 18: FAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '410', 'groupId': 'OG000'}, {'value': '413', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '82', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '34.8', 'groupId': 'OG000', 'lowerLimit': '30.2', 'upperLimit': '39.5'}, {'value': '34.6', 'groupId': 'OG001', 'lowerLimit': '30.0', 'upperLimit': '39.3'}, {'value': '54.6', 'groupId': 'OG002', 'lowerLimit': '42.8', 'upperLimit': '64.9'}, {'value': '41.8', 'groupId': 'OG003', 'lowerLimit': '31.0', 'upperLimit': '52.3'}]}]}, {'title': 'Month 24: PD-L1-negative NSCLC analysis set', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '22.1', 'groupId': 'OG000', 'lowerLimit': '14.0', 'upperLimit': '31.3'}, {'value': '22.3', 'groupId': 'OG001', 'lowerLimit': '14.7', 'upperLimit': '30.9'}, {'value': '36.0', 'groupId': 'OG002', 'lowerLimit': '18.2', 'upperLimit': '54.2'}, {'value': '17.9', 'groupId': 'OG003', 'lowerLimit': '6.5', 'upperLimit': '33.7'}]}]}, {'title': 'Month 24: FAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '410', 'groupId': 'OG000'}, {'value': '413', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '82', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '25.7', 'groupId': 'OG000', 'lowerLimit': '21.6', 'upperLimit': '30.1'}, {'value': '23.4', 'groupId': 'OG001', 'lowerLimit': '19.4', 'upperLimit': '27.7'}, {'value': '44.2', 'groupId': 'OG002', 'lowerLimit': '32.9', 'upperLimit': '54.8'}, {'value': '30.4', 'groupId': 'OG003', 'lowerLimit': '20.7', 'upperLimit': '40.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Months 12, 18 and 24', 'description': 'The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1).\n\nPD-L1-negative analysis set included the subset of participants in FAS whose PD-L1 status was PD-L1-negative at baseline as defined by the Ventana SP263 PD-L1 Assay (ie, \\<1% PD-L1-membrane expression in tumoral tissue).\n\nGlobal Cohort: The FAS included all randomized participants prior to the end of global recruitment.\n\nChina Cohort: The China FAS included all randomized participants in the China cohort and were used for all China only efficacy analyses.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants included in PD-L1-negative NSCLC and FAS analysis sets are reported in this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Serum Concentrations of Durvalumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '410', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Global: Durvalumab + Tremelimumab', 'description': 'Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.'}, {'id': 'OG001', 'title': 'China: Durvalumab + Tremelimumab', 'description': 'Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.'}], 'classes': [{'title': 'Week 0: Pre-infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '401', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'NA = Below LLOQ. The LLOQ = 0.05 µg/mL.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'NA = Below lower limit of quantification (LLOQ). The LLOQ = 0.05 µg/mL.', 'groupId': 'OG001'}]}]}, {'title': 'Week 0: End of infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '399', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '418.6', 'spread': '74.8', 'groupId': 'OG000'}, {'value': '392.7', 'spread': '48.9', 'groupId': 'OG001'}]}]}, {'title': 'Week 12: Pre-infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '77.5', 'spread': '138.1', 'groupId': 'OG000'}, {'value': '72.4', 'spread': '55.0', 'groupId': 'OG001'}]}]}, {'title': 'Week 12: End of infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '434.3', 'spread': '105.6', 'groupId': 'OG000'}, {'value': '448.9', 'spread': '40.0', 'groupId': 'OG001'}]}]}, {'title': 'Week 24: Pre-infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '108.8', 'spread': '95.7', 'groupId': 'OG000'}, {'value': '85.6', 'spread': '93.9', 'groupId': 'OG001'}]}]}, {'title': 'Follow-up Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.8', 'spread': '253.9', 'groupId': 'OG000'}, {'value': '5.4', 'spread': '351.7', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose and within 1 hour after end of infusion at Week 0 and 12; pre-dose on Week 24 and at follow-up Month 3', 'description': 'Blood samples were collected to determine the serum concentration of durvalumab.', 'unitOfMeasure': 'microgram per milliliter (µg/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Global Cohort: The FAS included all randomized participants prior to the end of global recruitment. Any participants recruited in China, after global recruitment had ended, were not included in the FAS.\n\nChina Cohort: The China FAS included all randomized participants in the China cohort and were used for all China only efficacy analyses.'}, {'type': 'SECONDARY', 'title': 'Serum Concentrations of Tremelimumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '410', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Global: Durvalumab + Tremelimumab', 'description': 'Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.'}, {'id': 'OG001', 'title': 'China: Durvalumab + Tremelimumab', 'description': 'Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.'}], 'classes': [{'title': 'Week 0: Pre-infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '402', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'NA = Below LLOQ. The LLOQ = 0.05 µg/mL.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'NA = Below LLOQ. The LLOQ = 0.05 µg/mL.', 'groupId': 'OG001'}]}]}, {'title': 'Week 0: End of infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '398', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.3', 'spread': '38.7', 'groupId': 'OG000'}, {'value': '18.4', 'spread': '43.3', 'groupId': 'OG001'}]}]}, {'title': 'Week 12: Pre-infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '241', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.4', 'spread': '99.6', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '64.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 12: End of infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.8', 'spread': '67.4', 'groupId': 'OG000'}, {'value': '23.2', 'spread': '43.4', 'groupId': 'OG001'}]}]}, {'title': 'Follow-up Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'NA = Below LLOQ. The LLOQ = 0.05 µg/mL.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'NA = Below LLOQ. The LLOQ = 0.05 µg/mL.', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose and within 1 hour after end of infusion at Week 0 and 12, and at follow-up Month 3', 'description': 'Blood samples were collected to determine the serum concentration of tremelimumab.', 'unitOfMeasure': 'µg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Global Cohort: The FAS included all randomized participants prior to the end of global recruitment. Any participants recruited in China, after global recruitment had ended, were not included in the FAS.\n\nChina Cohort: The China FAS included all randomized participants in the China cohort and were used for all China only efficacy analyses.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Anti-Drug Antibody (ADA) Response to Durvalumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '266', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Global: Durvalumab + Tremelimumab', 'description': 'Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.'}, {'id': 'OG001', 'title': 'China: Durvalumab + Tremelimumab', 'description': 'Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.'}], 'classes': [{'title': 'ADA positive at any visit (ADA prevalence)', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Treatment-emergent ADA positive (ADA incidence)', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Treatment-boosted ADA', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Treatment-induced ADA (positive post-baseline only)', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'ADA positive post-baseline and positive at baseline', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Persistent positive', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Transient positive', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'nAb positive at any visit', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'ADA positive at baseline and not detected post-baseline', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Weeks 0, 12, and 24; 3 and 6 months after last dose of study treatment.', 'description': 'Blood samples were measured for the presence of ADAs and ADA-neutralizing antibodies (nAb) for durvalumab using validated assays. ADA prevalence is defined as the percentage of participants with positive ADA result at any time, baseline or post-baseline. Treatment-emergent ADA is defined as the sum of treatment-induced ADA and treatment-boosted ADA. ADA incidence is the percentage of participants who were treatment-emergent ADA-positive. Treatment-boosted ADA is defined as baseline positive ADA titer that was boosted to \\>=4 fold during the study period. Persistently positive is defined as having at least 2 post baseline ADA positive measurements with at least 16 weeks (112 days) between the first and last positive measurements, or an ADA positive result at the last available assessment. Transiently positive is defined as having at least 1 post baseline ADA positive measurement and not fulfilling the conditions for persistently positive.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Global Cohort: The FAS included all randomized participants prior to the end of global recruitment. Any participants recruited in China, after global recruitment had ended, were not included in the FAS.\n\nChina Cohort: The China FAS included all randomized participants in the China cohort and were used for all China only efficacy analyses.\n\nThe denominator for calculation of percentage for all categories is the number of ADA evaluable participants.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With ADA Response to Tremelimumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Global: Durvalumab + Tremelimumab', 'description': 'Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.'}, {'id': 'OG001', 'title': 'China: Durvalumab + Tremelimumab', 'description': 'Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.'}], 'classes': [{'title': 'ADA positive at any visit (ADA prevalence)', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Treatment-emergent ADA positive (ADA incidence)', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Treatment-boosted ADA', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Treatment-induced ADA (positive post-baseline only)', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'ADA positive post-baseline and positive at baseline', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Persistent positive', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Transient positive', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'nAb positive at any visit', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'ADA positive at baseline and not detected post-baseline', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Weeks 0 and 12; 3 and 6 months after last dose of study treatment.', 'description': 'Blood samples were measured for the presence of ADAs and ADA-nAb for tremelimumab using validated assays. ADA prevalence is defined as the percentage of participants with positive ADA result at any time, baseline or post-baseline. Treatment-emergent ADA is defined as the sum of treatment-induced ADA and treatment-boosted ADA. ADA incidence is the percentage of participants who were treatment-emergent ADA-positive. Treatment-boosted ADA is defined as baseline positive ADA titer that was boosted to \\>=4 fold during the study period. Persistently positive is defined as having at least 2 post baseline ADA positive measurements with at least 16 weeks (112 days) between the first and last positive measurements, or an ADA positive result at the last available assessment. Transiently positive is defined as having at least 1 post baseline ADA positive measurement and not fulfilling the conditions for persistently positive.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Global Cohort: The FAS included all randomized participants prior to the end of global recruitment. Any participants recruited in China, after global recruitment had ended, were not included in the FAS.\n\nChina Cohort: The China FAS included all randomized participants in the China cohort and were used for all China only efficacy analyses.\n\nThe denominator for calculation of percentage for all categories is the number of ADA evaluable participants.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Participants: Durvalumab + Tremelimumab', 'description': 'Participants received durvalumab 20 milligram per kilogram (mg/kg) and tremelimumab 1 mg/kg intravenous (IV) infusion every 4 weeks (Q4W) in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective disease progression (PD), initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.'}, {'id': 'FG001', 'title': 'All Participants: SoC Chemotherapy', 'description': 'Participants received 1 of the following IV infusion treatment combinations on Day 1 of each 21-day cycle for 4 to 6 cycles or until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.\n\n1. Paclitaxel 200 mg/square meter (m\\^2) and carboplatin area under the plasma concentration curve (AUC) 5 or 6 mg\\*minute per milliliter (mg\\*min/mL).\n2. Gemcitabine 1000 or 1250 mg/m\\^2 and cisplatin 75 or 80 mg/m\\^2. Additional dose of gemcitabine 1000 or 1250 mg/m\\^2 on Day 8 of each cycle (For squamous participants only).\n3. Gemcitabine 1000 or 1250 mg/m\\^2 and carboplatin AUC 5 or 6 mg\\*min/mL. Additional dose of gemcitabine 1000 or 1250 mg/m\\^2 on Day 8 of each cycle (For squamous participants only).\n4. Pemetrexed 500 mg/m\\^2 and cisplatin 75 mg/m\\^2 (For non-squamous participants only; pemetrexed maintenance dose was permitted).\n5. Pemetrexed 500 mg/m\\^2 and carboplatin AUC 5 or 6 mg\\*min/mL (For non-squamous participants only; pemetrexed maintenance dose was permitted).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Randomized in overall study', 'achievements': [{'groupId': 'FG000', 'numSubjects': '474'}, {'groupId': 'FG001', 'numSubjects': '479'}]}, {'type': 'Randomized in Global Cohort', 'achievements': [{'groupId': 'FG000', 'numSubjects': '410'}, {'groupId': 'FG001', 'numSubjects': '413'}]}, {'type': 'Received Treatment in Global Cohort', 'achievements': [{'groupId': 'FG000', 'numSubjects': '410'}, {'groupId': 'FG001', 'numSubjects': '399'}]}, {'type': 'Randomized in China Cohort', 'achievements': [{'groupId': 'FG000', 'numSubjects': '78'}, {'groupId': 'FG001', 'numSubjects': '82'}]}, {'type': 'Received Treatment in China Cohort', 'achievements': [{'groupId': 'FG000', 'numSubjects': '77'}, {'groupId': 'FG001', 'numSubjects': '78'}]}, {'type': 'Included in Both Cohorts (Global and China)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'Ongoing in Study at DCO for Final Analysis in Global Cohort', 'achievements': [{'groupId': 'FG000', 'numSubjects': '75'}, {'groupId': 'FG001', 'numSubjects': '67'}]}, {'type': 'Ongoing in Study at DCO for Final Analysis in China Cohort', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'comment': 'Ongoing in overall study at DCO for final analysis.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '99'}, {'groupId': 'FG001', 'numSubjects': '83'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '375'}, {'groupId': 'FG001', 'numSubjects': '396'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '367'}, {'groupId': 'FG001', 'numSubjects': '377'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '19'}]}]}], 'recruitmentDetails': 'A total of 192 centers across 29 countries in North America, Latin America, Asia, Europe and Gulf countries randomized adults with epidermal growth factor receptor and anaplastic lymphoma kinase wild-type advanced or metastatic non-small-cell lung cancer (NSCLC) in this study. First participant was enrolled on 03 November 2015 and final data cut-off (DCO) date was 24 June 2019 for Global cohort and 21 September 2020 for China cohort. SoC = standard of care', 'preAssignmentDetails': '823 participants in Global cohort and 160 participants in China cohort were randomized in 1:1 ratio to receive durvalumab + tremelimumab or SoC chemotherapy. China cohort comprised participants from mainland China (30 from Global cohort and 130 randomized after end of Global cohort recruitment). Thus, 953 unique participants were randomized in the study overall. Participants included in both cohorts for Started, Completed and Reasons for Not Completed are not double-counted for participant flow.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '474', 'groupId': 'BG000'}, {'value': '479', 'groupId': 'BG001'}, {'value': '953', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants: Durvalumab + Tremelimumab', 'description': 'Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.'}, {'id': 'BG001', 'title': 'All Participants: SoC Chemotherapy', 'description': 'Participants received 1 of the following IV infusion treatment combinations on Day 1 of each 21-day cycle for 4 to 6 cycles or until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.\n\n1. Paclitaxel 200 mg/m\\^2 and carboplatin AUC 5 or 6 mg\\*min/mL.\n2. Gemcitabine 1000 or 1250 mg/m\\^2 and cisplatin 75 or 80 mg/m\\^2. Additional dose of gemcitabine 1000 or 1250 mg/m\\^2 on Day 8 of each cycle (For squamous participants only).\n3. Gemcitabine 1000 or 1250 mg/m\\^2 and carboplatin AUC 5 or 6 mg\\*min/mL. Additional dose of gemcitabine 1000 or 1250 mg/m\\^2 on Day 8 of each cycle (For squamous participants only).\n4. Pemetrexed 500 mg/m\\^2 and cisplatin 75 mg/m\\^2 (For non-squamous participants only; pemetrexed maintenance dose was permitted).\n5. Pemetrexed 500 mg/m\\^2 and carboplatin AUC 5 or 6 mg\\*min/mL (For non-squamous participants only; pemetrexed maintenance dose was permitted).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'All participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '474', 'groupId': 'BG000'}, {'value': '479', 'groupId': 'BG001'}, {'value': '953', 'groupId': 'BG002'}]}], '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': '278', 'groupId': 'BG000'}, {'value': '244', 'groupId': 'BG001'}, {'value': '522', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '196', 'groupId': 'BG000'}, {'value': '235', 'groupId': 'BG001'}, {'value': '431', 'groupId': 'BG002'}]}]}, {'title': 'Global cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '410', 'groupId': 'BG000'}, {'value': '413', 'groupId': 'BG001'}, {'value': '823', 'groupId': 'BG002'}]}], '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': '233', 'groupId': 'BG000'}, {'value': '203', 'groupId': 'BG001'}, {'value': '436', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '177', 'groupId': 'BG000'}, {'value': '210', 'groupId': 'BG001'}, {'value': '387', 'groupId': 'BG002'}]}]}, {'title': 'China cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}]}], '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': '53', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Baseline data is presented for all participants, as well as separately for the Global and China cohorts.'}, {'title': 'Sex: Female, Male', 'classes': [{'title': 'All participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '474', 'groupId': 'BG000'}, {'value': '479', 'groupId': 'BG001'}, {'value': '953', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '127', 'groupId': 'BG000'}, {'value': '129', 'groupId': 'BG001'}, {'value': '256', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '347', 'groupId': 'BG000'}, {'value': '350', 'groupId': 'BG001'}, {'value': '697', 'groupId': 'BG002'}]}]}, {'title': 'Global cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '410', 'groupId': 'BG000'}, {'value': '413', 'groupId': 'BG001'}, {'value': '823', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '113', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '221', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '297', 'groupId': 'BG000'}, {'value': '305', 'groupId': 'BG001'}, {'value': '602', 'groupId': 'BG002'}]}]}, {'title': 'China cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Baseline data is presented for all participants, as well as separately for the Global and China cohorts.'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'All participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '474', 'groupId': 'BG000'}, {'value': '479', 'groupId': 'BG001'}, {'value': '953', 'groupId': 'BG002'}]}], 'categories': [{'title': 'White', 'measurements': [{'value': '307', 'groupId': 'BG000'}, {'value': '289', 'groupId': 'BG001'}, {'value': '596', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '150', 'groupId': 'BG000'}, {'value': '165', 'groupId': 'BG001'}, {'value': '315', 'groupId': 'BG002'}]}, {'title': 'American Indian or Alaska Native', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Global cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '410', 'groupId': 'BG000'}, {'value': '413', 'groupId': 'BG001'}, {'value': '823', 'groupId': 'BG002'}]}], 'categories': [{'title': 'White', 'measurements': [{'value': '307', 'groupId': 'BG000'}, {'value': '289', 'groupId': 'BG001'}, {'value': '596', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '185', 'groupId': 'BG002'}]}, {'title': 'American Indian or Alaska Native', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'China cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}]}], 'categories': [{'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '78', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}]}, {'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Baseline data is presented for all participants, as well as separately for the Global and China cohorts.'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'All participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '474', 'groupId': 'BG000'}, {'value': '479', 'groupId': 'BG001'}, {'value': '953', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '423', 'groupId': 'BG000'}, {'value': '429', 'groupId': 'BG001'}, {'value': '852', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Global cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '410', 'groupId': 'BG000'}, {'value': '413', 'groupId': 'BG001'}, {'value': '823', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '359', 'groupId': 'BG000'}, {'value': '363', 'groupId': 'BG001'}, {'value': '722', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'China cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '78', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Baseline data is presented for all participants, as well as separately for the Global and China cohorts.'}], 'populationDescription': "Global Cohort: The full analysis set (FAS) included all randomized participants prior to the end of global recruitment. Any participants recruited in China, after global recruitment had ended, were not included in the FAS.\n\nChina Cohort: The China FAS included all randomized participants in the China cohort and were used for all China only efficacy analyses.\n\nParticipants included in both cohorts are not double-counted for the baseline characteristics analysis represented by 'All participants'."}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-01-20', 'size': 1365246, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-09-20T09:39', 'hasProtocol': True}, {'date': '2019-05-17', 'size': 653833, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-09-20T09:39', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 953}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-11-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-12', 'studyFirstSubmitDate': '2015-08-26', 'resultsFirstSubmitDate': '2021-09-20', 'studyFirstSubmitQcDate': '2015-09-03', 'lastUpdatePostDateStruct': {'date': '2025-09-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2022-04-29', 'studyFirstPostDateStruct': {'date': '2015-09-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival (OS); Global Cohort: Blood Tumor Mutational Burden (bTMB) ≥20 Mutations Per Megabase (Mut/Mb) Analysis Set', 'timeFrame': 'From baseline (Day 1, Week 0) until death due to any cause, assessed up to the Global cohort DCO date (a maximum of approximately 44 months).', 'description': 'The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique.'}, {'measure': 'OS; China Cohort: China Programmed Cell Death Ligand 1 (PD-L1) Negative NSCLC Analysis Set', 'timeFrame': 'From baseline (Day 1, Week 0) until death due to any cause, assessed up to the China cohort DCO date (a maximum of approximately 44 months).', 'description': 'The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique.'}], 'secondaryOutcomes': [{'measure': 'OS; Global Cohort: bTMB ≥16 Mut/Mb, bTMB ≥12 Mut/Mb, PD-L1-Negative NSCLC, bTMB <20 Mut/Mb, bTMB Non-Evaluable Population, tTMB ≥14 Mut/Mb, tTMB ≥12 Mut/Mb, tTMB ≥10 Mut/Mb, and tTMB ≥8 Mut/Mb Analysis Sets', 'timeFrame': 'From baseline (Day 1, Week 0) until death due to any cause, assessed up to the Global cohort DCO date (a maximum of approximately 44 months).', 'description': 'OS was defined as time from date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at time of analysis was censored based on last recorded date on which participant was known to be alive.\n\nbTMB ≥16 mut/Mb, bTMB ≥12 mut/Mb and bTMB \\<20 mut/Mb analysis sets included the subset of participants in FAS whose bTMB status was ≥16 mut/Mb, ≥12 mut/Mb and \\<20 mut/Mb, respectively at baseline as defined by the GuardantOMNI CDx assay.\n\nPD-L1-negative analysis set included the subset of participants in FAS whose PD-L1 status was PD-L1-negative at baseline as defined by the Ventana SP263 PD-L1 Assay (ie, \\<1% PD-L1-membrane expression in tumoral tissue).\n\nbTMB non-evaluable analysis set included the subset of participants in FAS whose bTMB status at baseline could not be determined by the GuardantOMNI CDx assay or whose sample was not available.\n\ntTMB analysis sets are defined same as the bTMB analysis sets.'}, {'measure': 'OS; Global and China Cohorts: FAS, PD-L1 Tumor Cell (TC) ≥25%, and PD-L1 TC ≥50% Analysis Sets', 'timeFrame': 'From baseline (Day 1, Week 0) until death due to any cause, assessed up to the Global or China cohort DCO dates, as applicable (a maximum of approximately 44 months) for each cohort.', 'description': 'The OS was defined as time from date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis was censored based on last recorded date on which participant was known to be alive.\n\nGlobal Cohort: The FAS included all randomized participants prior to the end of global recruitment. Any participants recruited in China, after global recruitment had ended, were not included in the FAS.\n\nChina Cohort: The China FAS included all randomized participants in the China cohort and were used for all China only efficacy analyses.\n\nPD-L1 TC ≥25% and PD-L1 TC ≥50% analysis sets included the subset of participants in the FAS whose PD-L1 status was TC ≥25% and TC ≥50% membrane expression in tumoral tissue, respectively at baseline as defined by the Ventana SP263 PD-L1 Assay.'}, {'measure': 'Progression-Free Survival (PFS); Global Cohort: bTMB ≥20 Mut/Mb, bTMB ≥16 Mut/Mb, bTMB ≥12 Mut/Mb, tTMB ≥14 Mut/Mb, tTMB ≥12 Mut/Mb, tTMB ≥10 Mut/Mb, and tTMB ≥8 Mut/Mb Analysis Sets', 'timeFrame': 'Tumour scans performed at baseline and every 6 weeks up to 48 weeks relative to date of randomization, then every 8 weeks thereafter until confirmed PD/death. Up to Global cohort DCO date (approximately 44 months).', 'description': 'The PFS (per Response Evaluation Criteria in Solid Tumors, version 1.1 \\[RECIST 1.1\\] using Investigator assessments) was defined as the time from the date of randomization until the date of objective PD or death (by any cause in the absence of progression) regardless of whether the participant withdrew from randomized therapy or received another anticancer therapy prior to progression (ie, date of PFS event or censoring - date of randomization + 1).\n\nbTMB ≥20 mut/Mb, bTMB ≥16 mut/Mb and bTMB ≥12 mut/Mb analysis sets included the subset of participants in FAS whose bTMB status was ≥20 mut/Mb, ≥16 mut/Mb and ≥12 mut/Mb, respectively at baseline as defined by the GuardantOMNI CDx assay.\n\ntTMB ≥14 mut/Mb, tTMB ≥12 mut/Mb, tTMB ≥10 mut/Mb and tTMB ≥8 mut/Mb analysis sets included the subset of participants in FAS whose tTMB status was ≥14 mut/Mb, ≥12 mut/Mb, ≥10 mut/Mb and ≥8 mut/Mb, respectively at baseline as defined by the GuardantOMNI CDx assay.'}, {'measure': 'PFS; Global and China Cohorts: PD-L1-Negative NSCLC, FAS, PD-L1 TC ≥25%, and PD-L1 TC ≥50% Analysis Sets', 'timeFrame': 'Tumour scans performed at baseline and every 6 weeks up to 48 weeks relative to date of randomization, then every 8 weeks thereafter until confirmed PD/death. Up to Global or China cohort DCO dates, as applicable (approximately 44 months) for each cohort.', 'description': 'PFS (per RECIST 1.1 using Investigator assessments) was defined as time from date of randomization until date of objective PD or death regardless of whether participant withdrew from randomized therapy or received another anticancer therapy prior to progression (ie, date of PFS event or censoring - date of randomization + 1).\n\nPD-L1-negative analysis set included subset of participants in FAS whose PD-L1 status was PD-L1-negative at baseline as defined by Ventana SP263 PD-L1 Assay (ie, \\<1% PD-L1-membrane expression in tumoral tissue).\n\nGlobal Cohort: FAS included all randomized participants prior to end of global recruitment.\n\nChina Cohort: China FAS included all randomized participants in China cohort and were used for all China only efficacy analyses.\n\nPD-L1 TC ≥25% and PD-L1 TC ≥50% analysis sets included subset of participants in FAS whose PD-L1 status was TC ≥25% and TC ≥50% membrane expression in tumoral tissue, respectively at baseline as defined by the Ventana SP263 PD-L1 Assay.'}, {'measure': 'Objective Response Rate (ORR); Global Cohort: bTMB ≥20 Mut/Mb, bTMB ≥16 Mut/Mb, bTMB ≥12 Mut/Mb, tTMB ≥14 Mut/Mb, tTMB ≥12 Mut/Mb, tTMB ≥10 Mut/Mb, and tTMB ≥8 Mut/Mb Analysis Sets', 'timeFrame': 'Tumour scans performed at baseline and every 6 weeks up to 48 weeks relative to date of randomization, then every 8 weeks thereafter until confirmed PD/death. Up to Global cohort DCO date (approximately 44 months).', 'description': 'The ORR (per RECIST 1.1 using Investigator assessments) was defined as the percentage of participants with at least 1 visit response of complete response (CR) or partial response (PR) prior to PD.\n\nbTMB ≥20 mut/Mb, bTMB ≥16 mut/Mb and bTMB ≥12 mut/Mb analysis sets included the subset of participants in FAS whose bTMB status was ≥20 mut/Mb, ≥16 mut/Mb and ≥12 mut/Mb, respectively at baseline as defined by the GuardantOMNI CDx assay.\n\ntTMB ≥14 mut/Mb, tTMB ≥12 mut/Mb, tTMB ≥10 mut/Mb and tTMB ≥8 mut/Mb analysis sets included the subset of participants in FAS whose tTMB status was ≥14 mut/Mb, ≥12 mut/Mb, ≥10 mut/Mb and ≥8 mut/Mb, respectively at baseline as defined by the GuardantOMNI CDx assay.'}, {'measure': 'ORR; Global and China Cohorts: PD-L1-Negative NSCLC, FAS, PD-L1 TC ≥25%, and PD-L1 TC ≥50% Analysis Sets', 'timeFrame': 'Tumour scans performed at baseline and every 6 weeks up to 48 weeks relative to date of randomization, then every 8 weeks thereafter until confirmed PD/death. Up to Global or China cohort DCO dates, as applicable (approximately 44 months) for each cohort.', 'description': 'The ORR (per RECIST 1.1 using Investigator assessments) was defined as the percentage of participants with at least 1 visit response of CR or PR prior to PD.\n\nPD-L1-negative analysis set included the subset of participants in FAS whose PD-L1 status was PD-L1-negative at baseline as defined by the Ventana SP263 PD-L1 Assay (ie, \\<1% PD-L1-membrane expression in tumoral tissue).\n\nGlobal Cohort: The FAS included all randomized participants prior to the end of global recruitment.\n\nChina Cohort: The China FAS included all randomized participants in the China cohort and were used for all China only efficacy analyses.\n\nPD-L1 TC ≥25% and PD-L1 TC ≥50% analysis sets included the subset of participants in the FAS whose PD-L1 status was TC ≥25% and TC ≥50% membrane expression in tumoral tissue, respectively at baseline as defined by the Ventana SP263 PD-L1 Assay.'}, {'measure': 'Duration of Response (DoR); Global Cohort: bTMB ≥20 Mut/Mb, bTMB ≥16 Mut/Mb, and bTMB ≥12 Mut/Mb Analysis Sets', 'timeFrame': 'Tumour scans performed at baseline and every 6 weeks up to 48 weeks relative to date of randomization, then every 8 weeks thereafter until confirmed PD/death. Up to Global cohort DCO date (approximately 44 months).', 'description': 'DoR (per RECIST 1.1 using Investigator assessments) was defined as the time from the date of first documented response (CR or PR) until the first date of documented progression or death in the absence of PD (ie, date of PFS event or censoring - date of first response + 1).\n\nbTMB ≥20 mut/Mb, bTMB ≥16 mut/Mb and bTMB ≥12 mut/Mb analysis sets included the subset of participants in FAS whose bTMB status was ≥20 mut/Mb, ≥16 mut/Mb and ≥12 mut/Mb, respectively at baseline as defined by the GuardantOMNI CDx assay.'}, {'measure': 'DoR; Global and China Cohorts: PD-L1-Negative NSCLC and FAS Analysis Sets', 'timeFrame': 'Tumour scans performed at baseline and every 6 weeks up to 48 weeks relative to date of randomization, then every 8 weeks thereafter until confirmed PD/death. Up to Global or China cohort DCO dates, as applicable (approximately 44 months) for each cohort.', 'description': 'DoR (per RECIST 1.1 using Investigator assessments) was defined as the time from the date of first documented response (CR or PR) until the first date of documented progression or death in the absence of PD (ie, date of PFS event or censoring - date of first response + 1).\n\nPD-L1-negative analysis set included the subset of participants in FAS whose PD-L1 status was PD-L1-negative at baseline as defined by the Ventana SP263 PD-L1 Assay (ie, \\<1% PD-L1-membrane expression in tumoral tissue).\n\nGlobal Cohort: The FAS included all randomized participants prior to the end of global recruitment.\n\nChina Cohort: The China FAS included all randomized participants in the China cohort and were used for all China only efficacy analyses.'}, {'measure': 'Alive and Progression-Free at 12 Months (APF12); Global Cohort: bTMB ≥20 Mut/Mb, bTMB ≥16 Mut/Mb, and bTMB ≥12 Mut/Mb Analysis Sets', 'timeFrame': 'Tumour scans performed at baseline then every 6 weeks up to 12 months.', 'description': 'The APF12 was defined as the percentage of participants who were alive and progression free at 12 months from randomization (ie, PFS rate at 12 months).\n\nbTMB ≥20 mut/Mb, bTMB ≥16 mut/Mb and bTMB ≥12 mut/Mb analysis sets included the subset of participants in FAS whose bTMB status was ≥20 mut/Mb, ≥16 mut/Mb and ≥12 mut/Mb, respectively at baseline as defined by the GuardantOMNI CDx assay.'}, {'measure': 'APF12; Global and China Cohorts: PD-L1-Negative NSCLC and FAS Analysis Sets', 'timeFrame': 'Tumour scans performed at baseline then every 6 weeks up to 12 months.', 'description': 'The APF12 was defined as the percentage of patients who were alive and progression free at 12 months from randomization (ie, PFS rate at 12 months).\n\nPD-L1-negative analysis set included the subset of participants in FAS whose PD-L1 status was PD-L1-negative at baseline as defined by the Ventana SP263 PD-L1 Assay (ie, \\<1% PD-L1-membrane expression in tumoral tissue).\n\nGlobal Cohort: The FAS included all randomized participants prior to the end of global recruitment.\n\nChina Cohort: The China FAS included all randomized participants in the China cohort and were used for all China only efficacy analyses.'}, {'measure': 'Time From Randomization to Second Progression or Death (PFS2); Global Cohort: bTMB ≥20 Mut/Mb, bTMB ≥16 Mut/Mb, and bTMB ≥12 Mut/Mb Analysis Sets', 'timeFrame': 'Tumour scans performed at baseline and every 6 weeks up to 48 weeks relative to date of randomization, then every 8 weeks thereafter until confirmed PD/death. Up to Global cohort DCO date (approximately 44 months).', 'description': 'The PFS2 was defined as the time from the date of randomization to the earliest of the progression events subsequent to that used for the primary variable PFS, or death (ie, date of PFS2 event or censoring - date of randomization + 1).\n\nbTMB ≥20 mut/Mb, bTMB ≥16 mut/Mb and bTMB ≥12 mut/Mb analysis sets included the subset of participants in FAS whose bTMB status was ≥20 mut/Mb, ≥16 mut/Mb and ≥12 mut/Mb, respectively at baseline as defined by the GuardantOMNI CDx assay.'}, {'measure': 'PFS2; Global and China Cohorts: PD-L1-Negative NSCLC and FAS Analysis Sets', 'timeFrame': 'Tumour scans performed at baseline and every 6 weeks up to 48 weeks relative to date of randomization, then every 8 weeks thereafter until confirmed PD/death. Up to Global or China cohort DCO dates, as applicable (approximately 44 months) for each cohort.', 'description': 'The PFS2 was defined as the time from the date of randomization to the earliest of the progression events subsequent to that used for the primary variable PFS, or death (ie, date of PFS2 event or censoring - date of randomization + 1).\n\nPD-L1-negative analysis set included the subset of participants in FAS whose PD-L1 status was PD-L1-negative at baseline as defined by the Ventana SP263 PD-L1 Assay (ie, \\<1% PD-L1-membrane expression in tumoral tissue).\n\nGlobal Cohort: The FAS included all randomized participants prior to the end of global recruitment.\n\nChina Cohort: The China FAS included all randomized participants in the China cohort and were used for all China only efficacy analyses.'}, {'measure': 'OS at Months 12, 18 and 24; Global Cohort: bTMB ≥20 Mut/Mb, bTMB ≥16 Mut/Mb, and bTMB ≥12 Mut/Mb Analysis Sets', 'timeFrame': 'Months 12, 18 and 24', 'description': 'The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1).\n\nbTMB ≥20 mut/Mb, bTMB ≥16 mut/Mb and bTMB ≥12 mut/Mb analysis sets included the subset of participants in FAS whose bTMB status was ≥20 mut/Mb, ≥16 mut/Mb and ≥12 mut/Mb, respectively at baseline as defined by the GuardantOMNI CDx assay.'}, {'measure': 'OS at Months 12, 18 and 24; Global and China Cohorts: PD-L1-Negative NSCLC and FAS Analysis Sets', 'timeFrame': 'Months 12, 18 and 24', 'description': 'The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1).\n\nPD-L1-negative analysis set included the subset of participants in FAS whose PD-L1 status was PD-L1-negative at baseline as defined by the Ventana SP263 PD-L1 Assay (ie, \\<1% PD-L1-membrane expression in tumoral tissue).\n\nGlobal Cohort: The FAS included all randomized participants prior to the end of global recruitment.\n\nChina Cohort: The China FAS included all randomized participants in the China cohort and were used for all China only efficacy analyses.'}, {'measure': 'Serum Concentrations of Durvalumab', 'timeFrame': 'Pre-dose and within 1 hour after end of infusion at Week 0 and 12; pre-dose on Week 24 and at follow-up Month 3', 'description': 'Blood samples were collected to determine the serum concentration of durvalumab.'}, {'measure': 'Serum Concentrations of Tremelimumab', 'timeFrame': 'Pre-dose and within 1 hour after end of infusion at Week 0 and 12, and at follow-up Month 3', 'description': 'Blood samples were collected to determine the serum concentration of tremelimumab.'}, {'measure': 'Number of Participants With Anti-Drug Antibody (ADA) Response to Durvalumab', 'timeFrame': 'At Weeks 0, 12, and 24; 3 and 6 months after last dose of study treatment.', 'description': 'Blood samples were measured for the presence of ADAs and ADA-neutralizing antibodies (nAb) for durvalumab using validated assays. ADA prevalence is defined as the percentage of participants with positive ADA result at any time, baseline or post-baseline. Treatment-emergent ADA is defined as the sum of treatment-induced ADA and treatment-boosted ADA. ADA incidence is the percentage of participants who were treatment-emergent ADA-positive. Treatment-boosted ADA is defined as baseline positive ADA titer that was boosted to \\>=4 fold during the study period. Persistently positive is defined as having at least 2 post baseline ADA positive measurements with at least 16 weeks (112 days) between the first and last positive measurements, or an ADA positive result at the last available assessment. Transiently positive is defined as having at least 1 post baseline ADA positive measurement and not fulfilling the conditions for persistently positive.'}, {'measure': 'Number of Participants With ADA Response to Tremelimumab', 'timeFrame': 'At Weeks 0 and 12; 3 and 6 months after last dose of study treatment.', 'description': 'Blood samples were measured for the presence of ADAs and ADA-nAb for tremelimumab using validated assays. ADA prevalence is defined as the percentage of participants with positive ADA result at any time, baseline or post-baseline. Treatment-emergent ADA is defined as the sum of treatment-induced ADA and treatment-boosted ADA. ADA incidence is the percentage of participants who were treatment-emergent ADA-positive. Treatment-boosted ADA is defined as baseline positive ADA titer that was boosted to \\>=4 fold during the study period. Persistently positive is defined as having at least 2 post baseline ADA positive measurements with at least 16 weeks (112 days) between the first and last positive measurements, or an ADA positive result at the last available assessment. Transiently positive is defined as having at least 1 post baseline ADA positive measurement and not fulfilling the conditions for persistently positive.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['NSCLC', 'PDL1', 'TMB', 'MEDI4736', 'Durvalumab', 'Tremelimumab', 'OS'], 'conditions': ['Non Small Cell Lung Carcinoma NSCLC']}, 'referencesModule': {'references': [{'pmid': '36806898', 'type': 'DERIVED', 'citation': 'Cheng Y, Zhou Q, Han B, Fan Y, Shan L, Chang J, Sun S, Fang J, Chen Y, Sun J, Wu G, Mann H, Naicker K, Shire N, Mok T, de Castro G Jr. NEPTUNE China cohort: First-line durvalumab plus tremelimumab in Chinese patients with metastatic non-small-cell lung cancer. Lung Cancer. 2023 Apr;178:87-95. doi: 10.1016/j.lungcan.2023.01.013. Epub 2023 Feb 1.'}], 'seeAlsoLinks': [{'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D419AC00003&attachmentIdentifier=8b9563bd-cf14-4923-8681-fa20813a5b58&fileName=D419AC00003_(Neptune)_Clinical_Study_Protocol_V9.0_Redacted.pdf&versionIdentifier=', 'label': 'Related Info'}, {'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D419AC00003&attachmentIdentifier=9e32a3a4-86d6-47b0-b0f2-852ff8a9c707&fileName=D419AC00003_(Neptune)_Statistical_Analysis_Plan_Redacted.pdf&versionIdentifier=', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized, open-label, multi-center, global, Phase III study to determine the efficacy and safety of durvalumab + tremelimumab combination therapy versus platinum-based SoC chemotherapy in the first-line treatment of patients with epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type advanced or metastatic NSCLC.', 'detailedDescription': 'Patients will be randomized in a 1:1 to receive treatment with durvalumab + tremelimumab combination therapy or SoC therapy. The primary objective of this study is to assess the efficacy of combination treatment compared with SoC in terms of Overall Survival (OS) in patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '130 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nFor inclusion in the study, patients should fulfill the following criteria:\n\n* Aged at least 18 years\n* Documented evidence of Stage IV NSCLC\n* No activating EGFR mutation or ALK rearrangement\n* No prior chemotherapy or any other systemic therapy for recurrent/metastatic NSCLC\n* World Health Organization (WHO) Performance Status of 0 or 1\n* No Prior exposure to Immune Mediated Therapy (IMT), including, but not limited to, other antiCTLA4, antiPD1, anti PDL1,or antiPDL2 antibodies, excluding therapeutic anticancer vaccines\n\nExclusion Criteria:\n\nPatients should not enter the study if any of the following exclusion criteria are fulfilled:\n\n* Mixed small cell lung cancer and NSCLC histology, sarcomatoid variant\n* Brain metastases or spinal cord compression unless the patient is stable (asymptomatic; no evidence of new or emerging brain metastases) and off steroids for at least 14 days prior to start of study treatment.\n* Active or prior documented autoimmune or inflammatory disorders (e.g., Crohn's disease, ulcerative colitis)"}, 'identificationModule': {'nctId': 'NCT02542293', 'acronym': 'NEPTUNE', 'briefTitle': 'Study of Durvalumab With Tremelimumab Versus SoC as 1st Line Therapy in Metastatic Non Small-Cell Lung Cancer (NSCLC) (NEPTUNE)', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase III Randomized, Open-Label, Multi-Center, Global Study of MEDI4736 in Combination With Tremelimumab Therapy Versus Standard of Care Platinum-Based Chemotherapy in First-Line Treatment of Patients With Advanced or Metastatic Non Small-Cell Lung Cancer (NSCLC).', 'orgStudyIdInfo': {'id': 'D419AC00003'}, 'secondaryIdInfos': [{'id': '2015-002197-21', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Combination Therapy', 'description': 'Durvalumab (PD-L1 monoclonal antibody) + Tremelimumab (monoclonal antibody directed against CTLA-4)', 'interventionNames': ['Biological: Durvalumab +Tremelimumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of Care', 'description': 'Standard of Care chemotherapy treatment', 'interventionNames': ['Drug: Paclitaxel + carboplatin', 'Drug: Gemcitabine + cisplatin', 'Drug: Gemcitabine + carboplatin', 'Drug: Pemetrexed + cisplatin', 'Drug: Pemetrexed + carboplatin']}], 'interventions': [{'name': 'Durvalumab +Tremelimumab', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Combination Therapy']}, {'name': 'Paclitaxel + carboplatin', 'type': 'DRUG', 'otherNames': ['Platinum based Standard of Care Chemotherapy'], 'description': 'Chemotherapy Agents', 'armGroupLabels': ['Standard of Care']}, {'name': 'Gemcitabine + cisplatin', 'type': 'DRUG', 'otherNames': ['Platinum based Standard of Care Chemotherapy'], 'description': 'Chemotherapy Agents', 'armGroupLabels': ['Standard of Care']}, {'name': 'Gemcitabine + carboplatin', 'type': 'DRUG', 'otherNames': ['Platinum based Standard of Care Chemotherapy'], 'description': 'Chemotherapy Agents', 'armGroupLabels': ['Standard of Care']}, {'name': 'Pemetrexed + cisplatin', 'type': 'DRUG', 'otherNames': ['Platinum based Standard of Care Chemotherapy'], 'description': 'Chemotherapy Agent', 'armGroupLabels': ['Standard of Care']}, {'name': 'Pemetrexed + carboplatin', 'type': 'DRUG', 'otherNames': ['Platinum based Standard of Care Chemotherapy'], 'description': 'Chemotherapy Agent', 'armGroupLabels': ['Standard of Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, 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