Ignite Creation Date:
2025-12-24 @ 6:49 PM
Ignite Modification Date:
2026-02-25 @ 10:05 PM
Study NCT ID:
NCT01905657
Status:
COMPLETED
Last Update Posted:
2021-10-06
First Post:
2013-07-18
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Two Doses of Pembrolizumab (MK-3475) Versus Docetaxel in Previously Treated Participants With Non-Small Cell Lung Cancer (MK-3475-010/KEYNOTE-010)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Argentina', 'Australia', 'Belgium', 'Brazil', 'Canada', 'Chile', 'Czechia', 'Denmark', 'France', 'Germany', 'Greece', 'Hungary', 'Italy', 'Japan', 'Lithuania', 'Netherlands', 'Portugal', 'Russia', 'South Africa', 'South Korea', 'Spain', 'Taiwan', 'United Kingdom', 'United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'C565324', 'term': 'Parkinson Disease 4, Autosomal Dominant Lewy Body'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C582435', 'term': 'pembrolizumab'}, {'id': 'D000077143', 'term': 'Docetaxel'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'otherDetails': 'The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this study 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses', 'description': 'Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.', 'eventGroups': [{'id': 'EG000', 'title': 'Pembrolizumab 2 mg/kg First Course', 'description': 'Participants received pembrolizumab 2 mg/kg IV over 30 minutes Q3W for up to 2 years.', 'otherNumAtRisk': 339, 'deathsNumAtRisk': 345, 'otherNumAffected': 312, 'seriousNumAtRisk': 339, 'deathsNumAffected': 294, 'seriousNumAffected': 124}, {'id': 'EG001', 'title': 'Pembrolizumab 10 mg/kg First Course', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years.', 'otherNumAtRisk': 343, 'deathsNumAtRisk': 346, 'otherNumAffected': 301, 'seriousNumAtRisk': 343, 'deathsNumAffected': 289, 'seriousNumAffected': 133}, {'id': 'EG002', 'title': 'Docetaxel 75 mg/m^2', 'description': 'Participants received docetaxel 75 mg/m\\^2 IV over 1 hour Q3W for up to 2 years.', 'otherNumAtRisk': 309, 'deathsNumAtRisk': 343, 'otherNumAffected': 279, 'seriousNumAtRisk': 309, 'deathsNumAffected': 303, 'seriousNumAffected': 107}, {'id': 'EG003', 'title': 'Pembrolizumab 2 mg/kg First Course to Pembrolizumab 200 mg Second Course', 'description': "Qualified participants who received the first course of pembrolizumab 2 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year.", 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 9, 'seriousNumAtRisk': 14, 'deathsNumAffected': 4, 'seriousNumAffected': 5}, {'id': 'EG004', 'title': 'Pembrolizumab 10 mg/kg First Course to Pembrolizumab 200 mg Second Course', 'description': "Qualified participants who received the first course of pembrolizumab 10 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year.", 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 5, 'seriousNumAtRisk': 7, 'deathsNumAffected': 2, 'seriousNumAffected': 2}, {'id': 'EG005', 'title': 'Docetaxel 75 mg/m^2 Switched Over to Pembrolizumab 200 mg', 'description': "Qualified participants who received docetaxel 75 mg/m\\^2 Q3W for up to 2 years, but experienced disease progression, switched over to pembrolizumab, at the investigator's discretion, at 200 mg IV Q3W for up to 2 years.", 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 7, 'seriousNumAtRisk': 8, 'deathsNumAffected': 6, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 339, 'numEvents': 50, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 43, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 309, 'numEvents': 71, 'numAffected': 61}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 339, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 309, 'numEvents': 103, 'numAffected': 47}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 339, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 19, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 309, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 339, 'numEvents': 30, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 34, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 309, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 339, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 309, 'numEvents': 18, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 339, 'numEvents': 24, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 23, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 309, 'numEvents': 17, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 339, 'numEvents': 65, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 64, 'numAffected': 57}, {'groupId': 'EG002', 'numAtRisk': 309, 'numEvents': 47, 'numAffected': 41}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 339, 'numEvents': 91, 'numAffected': 62}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 62, 'numAffected': 51}, {'groupId': 'EG002', 'numAtRisk': 309, 'numEvents': 111, 'numAffected': 81}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 5, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 339, 'numEvents': 105, 'numAffected': 87}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 92, 'numAffected': 75}, {'groupId': 'EG002', 'numAtRisk': 309, 'numEvents': 80, 'numAffected': 65}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 339, 'numEvents': 22, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 15, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 309, 'numEvents': 72, 'numAffected': 49}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 339, 'numEvents': 60, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 59, 'numAffected': 48}, {'groupId': 'EG002', 'numAtRisk': 309, 'numEvents': 37, 'numAffected': 32}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 339, 'numEvents': 60, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 59, 'numAffected': 45}, {'groupId': 'EG002', 'numAtRisk': 309, 'numEvents': 72, 'numAffected': 51}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 339, 'numEvents': 26, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 40, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 309, 'numEvents': 23, 'numAffected': 22}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 339, 'numEvents': 122, 'numAffected': 102}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 107, 'numAffected': 88}, {'groupId': 'EG002', 'numAtRisk': 309, 'numEvents': 131, 'numAffected': 106}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 339, 'numEvents': 35, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 30, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 309, 'numEvents': 37, 'numAffected': 34}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 339, 'numEvents': 68, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 64, 'numAffected': 40}, {'groupId': 'EG002', 'numAtRisk': 309, 'numEvents': 56, 'numAffected': 42}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 339, 'numEvents': 26, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 29, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 309, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 339, 'numEvents': 19, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 26, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 309, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 339, 'numEvents': 21, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 309, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 5, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 339, 'numEvents': 35, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 22, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 309, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 339, 'numEvents': 29, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 24, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 309, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 339, 'numEvents': 16, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 19, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 309, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 339, 'numEvents': 26, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 20, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 309, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 339, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 309, 'numEvents': 45, 'numAffected': 25}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 339, 'numEvents': 37, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 34, 'numAffected': 33}, {'groupId': 'EG002', 'numAtRisk': 309, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 339, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 6, 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{'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pulmonary hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 339, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 309, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 339, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 309, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pulmonary vascular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 339, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 309, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 339, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 309, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 339, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 309, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Drug eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 339, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 309, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 339, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 309, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 339, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 309, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 339, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 309, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 339, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 309, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 339, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 309, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Peripheral artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 339, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 309, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 339, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 309, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Superior vena cava occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 339, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 309, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Superior vena cava syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 339, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 309, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Biliary colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 339, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 309, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Infective spondylitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 339, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 309, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Otitis externa', 'stats': [{'groupId': 'EG000', 'numAtRisk': 339, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 309, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Nervous system disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 339, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 309, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 339, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 343, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 309, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '344', 'groupId': 'OG000'}, {'value': '346', 'groupId': 'OG001'}, {'value': '343', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab 2 mg/kg', 'description': "Participants received pembrolizumab 2 mg/kg IV over 30 minutes Q3W for up to 2 years. Qualified participants who received the first course of pembrolizumab 2 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year."}, {'id': 'OG001', 'title': 'Pembrolizumab 10 mg/kg', 'description': "Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years. Qualified participants who received the first course of pembrolizumab 10 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year."}, {'id': 'OG002', 'title': 'Docetaxel 75 mg/m^2', 'description': "Participants received docetaxel 75 mg/m\\^2 IV over 1 hour Q3W for up to 2 years. Qualified participants who received docetaxel 75 mg/m\\^2 Q3W for up to 2 years, but experienced disease progression, switched over to pembrolizumab, at the investigator's discretion, at 200 mg IV Q3W for up to 2 years."}], 'classes': [{'title': 'Strongly PD-L1 Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}, {'value': '152', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '14.9', 'comment': 'Upper limit of OS not reached, due to insufficient number of deaths in the study.', 'groupId': 'OG000', 'lowerLimit': '10.4', 'upperLimit': 'NA'}, {'value': '17.3', 'comment': 'Upper limit of OS not reached, due to insufficient number of deaths in the study.', 'groupId': 'OG001', 'lowerLimit': '11.8', 'upperLimit': 'NA'}, {'value': '8.2', 'groupId': 'OG002', 'lowerLimit': '6.4', 'upperLimit': '10.7'}]}]}, {'title': 'All PD-L1 Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '344', 'groupId': 'OG000'}, {'value': '346', 'groupId': 'OG001'}, {'value': '343', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '10.4', 'groupId': 'OG000', 'lowerLimit': '9.4', 'upperLimit': '11.9'}, {'value': '12.7', 'groupId': 'OG001', 'lowerLimit': '10.0', 'upperLimit': '17.3'}, {'value': '8.5', 'groupId': 'OG002', 'lowerLimit': '7.5', 'upperLimit': '9.8'}]}]}], 'analyses': [{'pValue': '0.00024', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.54', 'ciLowerLimit': '0.38', 'ciUpperLimit': '0.77', 'estimateComment': 'Numerator=Pembrolizumab 2 mg/kg Denominator=Docetaxel 75 mg/m\\^2', 'groupDescription': 'In participants with strongly PD-L1 positive tumors', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'nonInferiorityComment': 'Hazard Ratio based on stratified Cox regression model with treatment as a covariate and p-value based on stratified log-rank test, in accordance with the statistical analysis plan.'}, {'pValue': '0.00002', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.50', 'ciLowerLimit': '0.36', 'ciUpperLimit': '0.70', 'estimateComment': 'Numerator=Pembrolizumab 10 mg/kg Denominator=Docetaxel 75 mg/m\\^2', 'groupDescription': 'In participants with strongly PD-L1 positive tumors', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'nonInferiorityComment': 'Hazard Ratio based on stratified Cox regression model with treatment as a covariate and p-value based on stratified log-rank test, in accordance with the statistical analysis plan.'}, {'pValue': '0.00076', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.71', 'ciLowerLimit': '0.58', 'ciUpperLimit': '0.88', 'estimateComment': 'Numerator=Pembrolizumab 2 mg/kg Denominator=Docetaxel 75 mg/m\\^2', 'groupDescription': 'In participants with PD-L1 positive tumors', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'nonInferiorityComment': 'Hazard Ratio based on stratified Cox regression model with treatment as a covariate and p-value based on stratified log-rank test, in accordance with the statistical analysis plan.'}, {'pValue': '<0.00001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.61', 'ciLowerLimit': '0.49', 'ciUpperLimit': '0.75', 'estimateComment': 'Numerator=Pembrolizumab 10 mg/kg Denominator=Docetaxel 75 mg/m\\^2', 'groupDescription': 'In participants with PD-L1 positive tumors', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'nonInferiorityComment': 'Hazard Ratio based on stratified Cox regression model with treatment as a covariate and p-value based on stratified log-rank test, in accordance with the statistical analysis plan.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Through pre-specified database cutoff date of 30 Sep 2015 (Up to approximately 24 months)', 'description': 'OS was defined as the time from randomization to death due to any cause. OS was analyzed using the Kaplan-Meier method and is reported in months. Per protocol, final analysis for this primary outcome measure was performed for the first pembrolizumab course and docetaxel treatment arms, with a protocol-specified analysis data cutoff date of 30 September (Sep) 2015.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol, OS for the first pembrolizumab course and docetaxel treatment arms was analyzed in all randomized participants who had strongly PD-L1 positive and all PD-L1 positive OS data available and usable. Participants were included in the treatment group to which they were randomized.'}, {'type': 'PRIMARY', 'title': 'Progression-free Survival (PFS) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '344', 'groupId': 'OG000'}, {'value': '346', 'groupId': 'OG001'}, {'value': '343', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab 2 mg/kg', 'description': "Participants received pembrolizumab 2 mg/kg IV over 30 minutes Q3W for up to 2 years. Qualified participants who received the first course of pembrolizumab 2 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year."}, {'id': 'OG001', 'title': 'Pembrolizumab 10 mg/kg', 'description': "Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years. Qualified participants who received the first course of pembrolizumab 10 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year."}, {'id': 'OG002', 'title': 'Docetaxel 75 mg/m^2', 'description': "Participants received docetaxel 75 mg/m\\^2 IV over 1 hour Q3W for up to 2 years. Qualified participants who received docetaxel 75 mg/m\\^2 Q3W for up to 2 years, but experienced disease progression, switched over to pembrolizumab, at the investigator's discretion, at 200 mg IV Q3W for up to 2 years."}], 'classes': [{'title': 'Strongly PD-L1 Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}, {'value': '152', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.2', 'groupId': 'OG000', 'lowerLimit': '4.0', 'upperLimit': '6.5'}, {'value': '5.2', 'groupId': 'OG001', 'lowerLimit': '4.1', 'upperLimit': '8.1'}, {'value': '4.1', 'groupId': 'OG002', 'lowerLimit': '3.6', 'upperLimit': '4.3'}]}]}, {'title': 'All PD-L1 Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '344', 'groupId': 'OG000'}, {'value': '346', 'groupId': 'OG001'}, {'value': '343', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.9', 'groupId': 'OG000', 'lowerLimit': '3.1', 'upperLimit': '4.1'}, {'value': '4.0', 'groupId': 'OG001', 'lowerLimit': '2.6', 'upperLimit': '4.3'}, {'value': '4.0', 'groupId': 'OG002', 'lowerLimit': '3.1', 'upperLimit': '4.2'}]}]}], 'analyses': [{'pValue': '0.00009', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.58', 'ciLowerLimit': '0.43', 'ciUpperLimit': '0.77', 'estimateComment': 'Numerator=Pembrolizumab 2 mg/kg Denominator=Docetaxel 75 mg/m\\^2', 'groupDescription': 'In participants with strongly PD-L1 positive tumors', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'nonInferiorityComment': 'Hazard Ratio based on stratified Cox regression model with treatment as a covariate and p-value based on stratified log-rank test, in accordance with the statistical analysis plan.'}, {'pValue': '0.00007', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.59', 'ciLowerLimit': '0.45', 'ciUpperLimit': '0.78', 'estimateComment': 'Numerator=Pembrolizumab 10 mg/kg Denominator=Docetaxel 75 mg/m\\^2', 'groupDescription': 'In participants with strongly PD-L1 positive tumors', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'nonInferiorityComment': 'Hazard Ratio based on stratified Cox regression model with treatment as a covariate and p-value based on stratified log-rank test, in accordance with the statistical analysis plan.'}, {'pValue': '0.06758', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.88', 'ciLowerLimit': '0.73', 'ciUpperLimit': '1.04', 'estimateComment': 'Numerator=Pembrolizumab 2 mg/kg Denominator=Docetaxel 75 mg/m\\^2', 'groupDescription': 'In participants with PD-L1 positive tumors', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'nonInferiorityComment': 'Hazard Ratio based on stratified Cox regression model with treatment as a covariate and p-value based on stratified log-rank test, in accordance with the statistical analysis plan.'}, {'pValue': '0.00462', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.79', 'ciLowerLimit': '0.66', 'ciUpperLimit': '0.94', 'estimateComment': 'Numerator=Pembrolizumab 10 mg/kg Denominator=Docetaxel 75 mg/m\\^2', 'groupDescription': 'In participants with PD-L1 positive tumors', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'nonInferiorityComment': 'Hazard Ratio based on stratified Cox regression model with treatment as a covariate and p-value based on stratified log-rank test, in accordance with the statistical analysis plan.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Through pre-specified database cutoff date of 30 Sep 2015 (Up to approximately 24 months)', 'description': "PFS was defined as the time from the first day of study treatment to the first documented disease progression per RECIST 1.1 based on blinded independent central radiologists' review or death due to any cause, whichever occurred first. Using RECIST 1.1, progressive disease was defined as either a 20% relative increase in the sum of diameters of target lesions, taking as reference the smallest sum on study OR an absolute increase of \\>5 mm in the sum of lesions, OR the appearance of new lesions. PFS was analyzed using the Kaplan-Meier method and is reported in months. Per protocol, final analysis for this primary outcome measure was performed for the first pembrolizumab course and docetaxel treatment arms, with a protocol-specified analysis data cutoff date of 30 Sep 2015.", 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol, PFS for the first pembrolizumab course and docetaxel treatment arms was analyzed in all randomized participants who had strongly PD-L1 positive and all PD-L1 positive PFS data available and usable. Participants were included in the treatment group to which they were randomized.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Experiencing Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '339', 'groupId': 'OG000'}, {'value': '343', 'groupId': 'OG001'}, {'value': '309', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab 2 mg/kg', 'description': "Participants received pembrolizumab 2 mg/kg IV over 30 minutes Q3W for up to 2 years. Qualified participants who received the first course of pembrolizumab 2 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year."}, {'id': 'OG001', 'title': 'Pembrolizumab 10 mg/kg', 'description': "Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years. Qualified participants who received the first course of pembrolizumab 10 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year."}, {'id': 'OG002', 'title': 'Docetaxel 75 mg/m^2', 'description': "Participants received docetaxel 75 mg/m\\^2 IV over 1 hour Q3W for up to 2 years. Qualified participants who received docetaxel 75 mg/m\\^2 Q3W for up to 2 years, but experienced disease progression, switched over to pembrolizumab, at the investigator's discretion, at 200 mg IV Q3W for up to 2 years."}], 'classes': [{'categories': [{'measurements': [{'value': '97.6', 'groupId': 'OG000'}, {'value': '96.2', 'groupId': 'OG001'}, {'value': '96.1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Through pre-specified database cutoff date of 30 Sep 2015 (Up to approximately 24 months)', 'description': 'An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily had to have a causal relationship with this treatment. An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the study drug, was also an AE. Per protocol, final analysis for this primary outcome measure was performed for the first pembrolizumab course and docetaxel treatment arms, with a protocol-specified analysis data cutoff date of 30 Sep 2015.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol, participants experiencing AEs for the first pembrolizumab course and docetaxel treatment arms were analyzed in the All Participants As Treated (APAT) population. This consisted of all participants who received at least one dose of study drug. Participants were included in the treatment group based on the study treatment they received.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Discontinuing Study Drug Due to AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '339', 'groupId': 'OG000'}, {'value': '343', 'groupId': 'OG001'}, {'value': '309', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab 2 mg/kg', 'description': "Participants received pembrolizumab 2 mg/kg IV over 30 minutes Q3W for up to 2 years. Qualified participants who received the first course of pembrolizumab 2 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year."}, {'id': 'OG001', 'title': 'Pembrolizumab 10 mg/kg', 'description': "Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years. Qualified participants who received the first course of pembrolizumab 10 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year."}, {'id': 'OG002', 'title': 'Docetaxel 75 mg/m^2', 'description': "Participants received docetaxel 75 mg/m\\^2 IV over 1 hour Q3W for up to 2 years. Qualified participants who received docetaxel 75 mg/m\\^2 Q3W for up to 2 years, but experienced disease progression, switched over to pembrolizumab, at the investigator's discretion, at 200 mg IV Q3W for up to 2 years."}], 'classes': [{'categories': [{'measurements': [{'value': '8.3', 'groupId': 'OG000'}, {'value': '7.6', 'groupId': 'OG001'}, {'value': '13.6', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Through pre-specified database cutoff date of 30 Sep 2015 (Up to approximately 24 months)', 'description': 'An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily had to have a causal relationship with this treatment. An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the study drug, was also an AE. Per protocol, final analysis for this primary outcome measure was performed for the first pembrolizumab course and docetaxel treatment arms, with a protocol-specified analysis data cutoff date of 30 Sep 2015.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol, participants discontinuing study treatment due to AEs, for the first pembrolizumab course and docetaxel treatment arms were analyzed in the APAT population. This consisted of all participants who received at least one dose of study drug. Participants were included in the treatment group based on the study treatment they received.'}, {'type': 'SECONDARY', 'title': 'Overall Response Rate (ORR) by RECIST 1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '344', 'groupId': 'OG000'}, {'value': '346', 'groupId': 'OG001'}, {'value': '343', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab 2 mg/kg', 'description': "Participants received pembrolizumab 2 mg/kg IV over 30 minutes Q3W for up to 2 years. Qualified participants who received the first course of pembrolizumab 2 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year."}, {'id': 'OG001', 'title': 'Pembrolizumab 10 mg/kg', 'description': "Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years. Qualified participants who received the first course of pembrolizumab 10 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year."}, {'id': 'OG002', 'title': 'Docetaxel 75 mg/m^2', 'description': "Participants received docetaxel 75 mg/m\\^2 IV over 1 hour Q3W for up to 2 years. Qualified participants who received docetaxel 75 mg/m\\^2 Q3W for up to 2 years, but experienced disease progression, switched over to pembrolizumab, at the investigator's discretion, at 200 mg IV Q3W for up to 2 years."}], 'classes': [{'title': 'Strongly PD-L1 Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}, {'value': '152', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '30.2', 'groupId': 'OG000', 'lowerLimit': '22.7', 'upperLimit': '38.6'}, {'value': '29.1', 'groupId': 'OG001', 'lowerLimit': '22.0', 'upperLimit': '37.1'}, {'value': '7.9', 'groupId': 'OG002', 'lowerLimit': '4.1', 'upperLimit': '13.4'}]}]}, {'title': 'All PD-L1 Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '344', 'groupId': 'OG000'}, {'value': '346', 'groupId': 'OG001'}, {'value': '343', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '18.0', 'groupId': 'OG000', 'lowerLimit': '14.1', 'upperLimit': '22.5'}, {'value': '18.5', 'groupId': 'OG001', 'lowerLimit': '14.5', 'upperLimit': '23.0'}, {'value': '9.3', 'groupId': 'OG002', 'lowerLimit': '6.5', 'upperLimit': '12.9'}]}]}], 'analyses': [{'pValue': '0.66608', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.3', 'ciLowerLimit': '-12.7', 'ciUpperLimit': '8.2', 'pValueComment': 'P-value indicated for testing a difference in percentage equal to 0 versus a difference in percentage not equal to 0, in accordance with the statistical analysis plan.', 'estimateComment': 'This is an adjusted risk difference estimated by stratified Miettinen \\& Nurminen method.', 'groupDescription': 'In participants with strongly PD-L1 positive tumors', 'statisticalMethod': 'Miettinen & Nurminen method', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '<0.00001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '22.2', 'ciLowerLimit': '14.0', 'ciUpperLimit': '30.7', 'pValueComment': 'P-value indicated for testing a difference in percentage equal to 0 versus a difference in percentage greater than 0, in accordance with the statistical analysis plan.', 'estimateComment': 'This is an adjusted risk difference estimated by stratified Miettinen \\& Nurminen method.', 'groupDescription': 'In participants with strongly PD-L1 positive tumors', 'statisticalMethod': 'Miettinen & Nurminen method', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.00045', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in Percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.7', 'ciLowerLimit': '3.6', 'ciUpperLimit': '13.9', 'pValueComment': 'P-value indicated for testing a difference in percentage equal to 0 versus a difference in percentage greater than 0, in accordance with the statistical analysis plan.', 'estimateComment': 'This is an adjusted risk difference estimated by stratified Miettinen \\& Nurminen method.', 'groupDescription': 'In participants with PD-L1 positive tumors', 'statisticalMethod': 'Miettinen & Nurminen method', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.00024', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.1', 'ciLowerLimit': '4.1', 'ciUpperLimit': '14.3', 'pValueComment': 'P-value indicated for testing a difference in percentage equal to 0 versus a difference in percentage greater than 0, in accordance with the statistical analysis plan.', 'estimateComment': 'This is an adjusted risk difference estimated by stratified Miettinen \\& Nurminen method.', 'groupDescription': 'In participants with PD-L1 positive tumors', 'statisticalMethod': 'Miettinen & Nurminen method', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Through pre-specified database cutoff date of 30 Sep 2015 (Up to approximately 24 months)', 'description': "ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR; disappearance of all target lesions) or Partial Response (PR; at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters) based on blinded independent central radiologists' review using RECIST 1.1. Per protocol, final analysis for this secondary outcome measure was performed for the first pembrolizumab course and docetaxel treatment arms, with a protocol-specified analysis data cutoff date of 30 Sep 2015.", 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol, ORR for the first pembrolizumab course and docetaxel treatment arms was analyzed in all randomized participants who had strongly PD-L1 positive and all PD-L1 positive ORR data available and usable. Participants were included in the treatment group to which they were randomized.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DOR) by RECIST 1.1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab 2 mg/kg', 'description': "Participants received pembrolizumab 2 mg/kg IV over 30 minutes Q3W for up to 2 years. Qualified participants who received the first course of pembrolizumab 2 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year."}, {'id': 'OG001', 'title': 'Pembrolizumab 10 mg/kg', 'description': "Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years. Qualified participants who received the first course of pembrolizumab 10 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year."}, {'id': 'OG002', 'title': 'Docetaxel 75 mg/m^2', 'description': "Participants received docetaxel 75 mg/m\\^2 IV over 1 hour Q3W for up to 2 years. Qualified participants who received docetaxel 75 mg/m\\^2 Q3W for up to 2 years, but experienced disease progression, switched over to pembrolizumab, at the investigator's discretion, at 200 mg IV Q3W for up to 2 years."}], 'classes': [{'title': 'Strongly PD-L1 Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median DOR and DOR upper limit not reached: No progressive disease by the time of last disease assessment.', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median DOR and DOR upper limit not reached: No progressive disease by the time of last disease assessment.', 'groupId': 'OG001', 'lowerLimit': '9', 'upperLimit': 'NA'}, {'value': '35', 'comment': 'DOR upper limit not reached: No progressive disease by the time of last disease assessment.', 'groupId': 'OG002', 'lowerLimit': '9', 'upperLimit': 'NA'}]}]}, {'title': 'All PD-L1 Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median DOR and DOR upper limit not reached: No progressive disease by the time of last disease assessment.', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median DOR and DOR upper limit not reached: No progressive disease by the time of last disease assessment.', 'groupId': 'OG001', 'lowerLimit': '9', 'upperLimit': 'NA'}, {'value': '27', 'comment': 'DOR upper limit not reached: No progressive disease by the time of last disease assessment.', 'groupId': 'OG002', 'lowerLimit': '6', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Through pre-specified database cutoff date of 30 Sep 2015 (Up to approximately 24 months)', 'description': 'DOR is measured from the time measurement criteria were first met for CR/PR (whichever was first recorded) until the first date that death or progressive disease was objectively documented (taking as reference for progressive disease the smallest measurements recorded on study). Non-responders were not included in the analysis. DOR was analyzed using the Kaplan-Meier method and is reported in weeks. Per protocol, final analysis for this secondary outcome measure was performed for the first pembrolizumab course and docetaxel treatment arms, with a protocol-specified analysis data cutoff date of 30 Sep 2015.', 'unitOfMeasure': 'Weeks', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol, DOR for the first pembrolizumab course and docetaxel treatment arms was analyzed in all randomized participants who demonstrated a CR/PR and had strongly PD-L1 positive and all PD-L1 positive DOR data available and usable. Participants were included in the treatment group to which they were randomized.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pembrolizumab 2 mg/kg', 'description': "Participants received pembrolizumab 2 mg/kg intravenously (IV) over 30 minutes every 3 weeks (Q3W) for up to 2 years. Qualified participants who received the first course of pembrolizumab 2 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year."}, {'id': 'FG001', 'title': 'Pembrolizumab 10 mg/kg', 'description': "Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years. Qualified participants who received the first course of pembrolizumab 10 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year."}, {'id': 'FG002', 'title': 'Docetaxel 75 mg/m^2', 'description': "Participants received docetaxel 75 mg/m\\^2 IV over 1 hour Q3W for up to 2 years. Qualified participants who received docetaxel 75 mg/m\\^2 Q3W for up to 2 years, but experienced disease progression, switched over to pembrolizumab, at the investigator's discretion, at 200 mg IV Q3W for up to 2 years."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '345'}, {'groupId': 'FG001', 'numSubjects': '346'}, {'groupId': 'FG002', 'numSubjects': '343'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '339'}, {'groupId': 'FG001', 'numSubjects': '343'}, {'groupId': 'FG002', 'numSubjects': '309'}]}, {'type': 'Received Second Course of Pembrolizumab', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Switched Over to Pembrolizumab', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '142'}, {'groupId': 'FG001', 'numSubjects': '159'}, {'groupId': 'FG002', 'numSubjects': '143'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '203'}, {'groupId': 'FG001', 'numSubjects': '187'}, {'groupId': 'FG002', 'numSubjects': '200'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '18'}]}, {'type': 'Clinical Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '103'}, {'groupId': 'FG001', 'numSubjects': '78'}, {'groupId': 'FG002', 'numSubjects': '59'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '43'}, {'groupId': 'FG002', 'numSubjects': '47'}]}, {'type': 'Excluded Medication', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '12'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Screen Failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '53'}]}, {'type': 'Sponsor Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants who had non-small cell lung cancer (NSCLC) and whose tumors were assessed as being programmed cell death ligand 1 (PD-L1) positive were recruited for this study.', 'preAssignmentDetails': 'Per protocol, response or progression during the second and switch over pembrolizumab courses was not counted towards efficacy outcome measures, and adverse events during the second and switch over pembrolizumab courses were not counted towards safety outcome measures.\n\nFinal analyses for all primary and secondary outcome measures was done at the protocol-specified cutoff of 30-Sep-2015.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '345', 'groupId': 'BG000'}, {'value': '346', 'groupId': 'BG001'}, {'value': '343', 'groupId': 'BG002'}, {'value': '1034', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Pembrolizumab 2 mg/kg', 'description': "Participants received pembrolizumab 2 mg/kg intravenously (IV) over 30 minutes every 3 weeks (Q3W) for up to 2 years. Qualified participants who received the first course of pembrolizumab 2 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year."}, {'id': 'BG001', 'title': 'Pembrolizumab 10 mg/kg', 'description': "Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years. Qualified participants who received the first course of pembrolizumab 10 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year."}, {'id': 'BG002', 'title': 'Docetaxel 75 mg/m^2', 'description': "Participants received docetaxel 75 mg/m\\^2 IV over 1 hour Q3W for up to 2 years. Qualified participants who received docetaxel 75 mg/m\\^2 Q3W for up to 2 years, but experienced disease progression, switched over to pembrolizumab, at the investigator's discretion, at 200 mg IV Q3W for up to 2 years."}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.1', 'spread': '9.6', 'groupId': 'BG000'}, {'value': '62.3', 'spread': '9.7', 'groupId': 'BG001'}, {'value': '61.6', 'spread': '9.8', 'groupId': 'BG002'}, {'value': '62.0', 'spread': '9.7', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '132', 'groupId': 'BG000'}, {'value': '133', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}, {'value': '399', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '213', 'groupId': 'BG000'}, {'value': '213', 'groupId': 'BG001'}, {'value': '209', 'groupId': 'BG002'}, {'value': '635', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'PD-L1 Tumor Expression Status', 'classes': [{'categories': [{'title': 'Weakly PD-L1 Positive', 'measurements': [{'value': '206', 'groupId': 'BG000'}, {'value': '195', 'groupId': 'BG001'}, {'value': '191', 'groupId': 'BG002'}, {'value': '592', 'groupId': 'BG003'}]}, {'title': 'Strongly PD-L1 Positive', 'measurements': [{'value': '139', 'groupId': 'BG000'}, {'value': '151', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}, {'value': '442', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'PD-L1 expression was evaluated by immunohistochemistry (IHC) assay with a newly obtained tumor tissue with biopsy. If PD-L1 expression was observed in ≥1%, but ≤49% of tumor cells, a participant was categorized as weakly PD-L1 positive. If PD-L1 expression was observed in ≥50% of tumor cells, a participant was categorized as strongly PD-L1 positive.', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-02-09', 'size': 3008648, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-09-13T10:26', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1034}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-13', 'studyFirstSubmitDate': '2013-07-18', 'resultsFirstSubmitDate': '2016-09-15', 'studyFirstSubmitQcDate': '2013-07-18', 'lastUpdatePostDateStruct': {'date': '2021-10-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-11-23', 'studyFirstPostDateStruct': {'date': '2013-07-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-01-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'Through pre-specified database cutoff date of 30 Sep 2015 (Up to approximately 24 months)', 'description': 'OS was defined as the time from randomization to death due to any cause. OS was analyzed using the Kaplan-Meier method and is reported in months. Per protocol, final analysis for this primary outcome measure was performed for the first pembrolizumab course and docetaxel treatment arms, with a protocol-specified analysis data cutoff date of 30 September (Sep) 2015.'}, {'measure': 'Progression-free Survival (PFS) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)', 'timeFrame': 'Through pre-specified database cutoff date of 30 Sep 2015 (Up to approximately 24 months)', 'description': "PFS was defined as the time from the first day of study treatment to the first documented disease progression per RECIST 1.1 based on blinded independent central radiologists' review or death due to any cause, whichever occurred first. Using RECIST 1.1, progressive disease was defined as either a 20% relative increase in the sum of diameters of target lesions, taking as reference the smallest sum on study OR an absolute increase of \\>5 mm in the sum of lesions, OR the appearance of new lesions. PFS was analyzed using the Kaplan-Meier method and is reported in months. Per protocol, final analysis for this primary outcome measure was performed for the first pembrolizumab course and docetaxel treatment arms, with a protocol-specified analysis data cutoff date of 30 Sep 2015."}, {'measure': 'Percentage of Participants Experiencing Adverse Events (AEs)', 'timeFrame': 'Through pre-specified database cutoff date of 30 Sep 2015 (Up to approximately 24 months)', 'description': 'An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily had to have a causal relationship with this treatment. An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the study drug, was also an AE. Per protocol, final analysis for this primary outcome measure was performed for the first pembrolizumab course and docetaxel treatment arms, with a protocol-specified analysis data cutoff date of 30 Sep 2015.'}, {'measure': 'Percentage of Participants Discontinuing Study Drug Due to AEs', 'timeFrame': 'Through pre-specified database cutoff date of 30 Sep 2015 (Up to approximately 24 months)', 'description': 'An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily had to have a causal relationship with this treatment. An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the study drug, was also an AE. Per protocol, final analysis for this primary outcome measure was performed for the first pembrolizumab course and docetaxel treatment arms, with a protocol-specified analysis data cutoff date of 30 Sep 2015.'}], 'secondaryOutcomes': [{'measure': 'Overall Response Rate (ORR) by RECIST 1.1', 'timeFrame': 'Through pre-specified database cutoff date of 30 Sep 2015 (Up to approximately 24 months)', 'description': "ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR; disappearance of all target lesions) or Partial Response (PR; at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters) based on blinded independent central radiologists' review using RECIST 1.1. Per protocol, final analysis for this secondary outcome measure was performed for the first pembrolizumab course and docetaxel treatment arms, with a protocol-specified analysis data cutoff date of 30 Sep 2015."}, {'measure': 'Duration of Response (DOR) by RECIST 1.1', 'timeFrame': 'Through pre-specified database cutoff date of 30 Sep 2015 (Up to approximately 24 months)', 'description': 'DOR is measured from the time measurement criteria were first met for CR/PR (whichever was first recorded) until the first date that death or progressive disease was objectively documented (taking as reference for progressive disease the smallest measurements recorded on study). Non-responders were not included in the analysis. DOR was analyzed using the Kaplan-Meier method and is reported in weeks. Per protocol, final analysis for this secondary outcome measure was performed for the first pembrolizumab course and docetaxel treatment arms, with a protocol-specified analysis data cutoff date of 30 Sep 2015.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Programmed Cell Death-1 (PD1, PD-1)', 'Programmed Death-Ligand 1 (PDL1, PD-L1)'], 'conditions': ['Non Small Cell Lung Cancer (NSCLC)']}, 'referencesModule': {'references': [{'pmid': '26712084', 'type': 'RESULT', 'citation': 'Herbst RS, Baas P, Kim DW, Felip E, Perez-Gracia JL, Han JY, Molina J, Kim JH, Arvis CD, Ahn MJ, Majem M, Fidler MJ, de Castro G Jr, Garrido M, Lubiniecki GM, Shentu Y, Im E, Dolled-Filhart M, Garon EB. Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010): a randomised controlled trial. Lancet. 2016 Apr 9;387(10027):1540-1550. doi: 10.1016/S0140-6736(15)01281-7. Epub 2015 Dec 19.'}, {'pmid': '35101941', 'type': 'DERIVED', 'citation': 'Cristescu R, Aurora-Garg D, Albright A, Xu L, Liu XQ, Loboda A, Lang L, Jin F, Rubin EH, Snyder A, Lunceford J. Tumor mutational burden predicts the efficacy of pembrolizumab monotherapy: a pan-tumor retrospective analysis of participants with advanced solid tumors. J Immunother Cancer. 2022 Jan;10(1):e003091. doi: 10.1136/jitc-2021-003091.'}, {'pmid': '33439727', 'type': 'DERIVED', 'citation': 'Jemielita T, Li XN, Piperdi B, Zhou W, Burke T, Chen C. Overall Survival With Second-Line Pembrolizumab in Patients With Non-Small-Cell Lung Cancer: Randomized Phase III Clinical Trial Versus Propensity-Adjusted Real-World Data. JCO Clin Cancer Inform. 2021 Jan;5:56-65. doi: 10.1200/CCI.20.00099.'}, {'pmid': '32305010', 'type': 'DERIVED', 'citation': 'Lala M, Li TR, de Alwis DP, Sinha V, Mayawala K, Yamamoto N, Siu LL, Chartash E, Aboshady H, Jain L. A six-weekly dosing schedule for pembrolizumab in patients with cancer based on evaluation using modelling and simulation. Eur J Cancer. 2020 May;131:68-75. doi: 10.1016/j.ejca.2020.02.016. Epub 2020 Apr 15.'}, {'pmid': '32078391', 'type': 'DERIVED', 'citation': 'Herbst RS, Garon EB, Kim DW, Cho BC, Perez-Gracia JL, Han JY, Arvis CD, Majem M, Forster MD, Monnet I, Novello S, Szalai Z, Gubens MA, Su WC, Ceresoli GL, Samkari A, Jensen EH, Lubiniecki GM, Baas P. Long-Term Outcomes and Retreatment Among Patients With Previously Treated, Programmed Death-Ligand 1-Positive, Advanced Non-Small-Cell Lung Cancer in the KEYNOTE-010 Study. J Clin Oncol. 2020 May 10;38(14):1580-1590. doi: 10.1200/JCO.19.02446. Epub 2020 Feb 20.'}, {'pmid': '31395089', 'type': 'DERIVED', 'citation': 'van Vugt MJH, Stone JA, De Greef RHJMM, Snyder ES, Lipka L, Turner DC, Chain A, Lala M, Li M, Robey SH, Kondic AG, De Alwis D, Mayawala K, Jain L, Freshwater T. Immunogenicity of pembrolizumab in patients with advanced tumors. J Immunother Cancer. 2019 Aug 8;7(1):212. doi: 10.1186/s40425-019-0663-4.'}, {'pmid': '30711649', 'type': 'DERIVED', 'citation': 'Barlesi F, Garon EB, Kim DW, Felip E, Han JY, Kim JH, Ahn MJ, Fidler MJ, Gubens MA, de Castro G Jr, Surmont V, Li Q, Deitz AC, Lubiniecki GM, Herbst RS. Health-Related Quality of Life in KEYNOTE-010: a Phase II/III Study of Pembrolizumab Versus Docetaxel in Patients With Previously Treated Advanced, Programmed Death Ligand 1-Expressing NSCLC. J Thorac Oncol. 2019 May;14(5):793-801. doi: 10.1016/j.jtho.2019.01.016. Epub 2019 Jan 31.'}, {'pmid': '30657853', 'type': 'DERIVED', 'citation': 'Herbst RS, Baas P, Perez-Gracia JL, Felip E, Kim DW, Han JY, Molina JR, Kim JH, Dubos Arvis C, Ahn MJ, Majem M, Fidler MJ, Surmont V, de Castro G Jr, Garrido M, Shentu Y, Emancipator K, Samkari A, Jensen EH, Lubiniecki GM, Garon EB. Use of archival versus newly collected tumor samples for assessing PD-L1 expression and overall survival: an updated analysis of KEYNOTE-010 trial. Ann Oncol. 2019 Feb 1;30(2):281-289. doi: 10.1093/annonc/mdy545.'}], 'seeAlsoLinks': [{'url': 'http://merckoncologyclinicaltrials.com', 'label': 'Merck Oncology Clinical Trial Information'}]}, 'descriptionModule': {'briefSummary': "This study compared two doses of pembrolizumab (MK-3475) versus docetaxel in participants with non-small cell lung cancer (NSCLC) who had experienced disease progression after platinum-containing systemic therapy. Participants were assigned randomly to receive either pembrolizumab 2 mg/kg once every three weeks (Q3W), pembrolizumab 10 mg/kg Q3W or docetaxel 75 mg/m\\^2 Q3W. The total number of participants randomized depended upon demonstration of sufficient objective responses at an interim analysis.\n\nEligible participants who were allocated to the first course of pembrolizumab (2 mg/kg Q3W or 10 mg/kg Q3W) and experienced disease progression, to be permitted to receive a second course of pembrolizumab as long as Inclusion/Exclusion criteria were met.\n\nProtocol Amendment 12 (effective date: 09 Dec 2015) enabled eligible participants who were allocated to docetaxel and experienced disease progression, to be permitted to switch over to receive pembrolizumab 2 mg/kg Q3W as long as Inclusion/Exclusion criteria were met.\n\nWith Protocol Amendment 15 (effective date: 03 Jan 2018), all second course and switch over participants will receive pembrolizumab 200 mg Q3W. Response or progression during the second and switch over pembrolizumab courses will not count towards efficacy outcome measures, and adverse events during the second and switch over pembrolizumab courses will not count towards safety outcome measures.\n\nAlso with Amendment 15, once a participant has achieved the study objective or the study has ended, the participant will be discontinued from this study and enrolled in an extension study (Keynote 587; NCT03486873) to continue protocol-defined assessments and treatment. Switch over participants who have not transitioned to pembrolizumab will be considered for the extension study on a case-by-case basis.\n\nThe primary study hypotheses are that pembolizumab prolongs Overall Survival (OS) and Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by independent radiologists' review in previously-treated participants with NSCLC in the strongly positive programmed cell death ligand 1 (PD-L1) stratum compared to docetaxel and in participants whose tumors express PD-L1 compared to docetaxel."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Life expectancy of at least 3 months\n* Histologically- or cytologically-confirmed diagnosis of NSCLC that is anti-programmed cell death ligand 1 (PD-L1) positive per central laboratory review\n* At least one bi-dimensional measurable lesion\n* Radiographic progression after treatment with at least 2 cycles of a platinum-containing doublet\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1\n\nExclusion Criteria:\n\n* Prior therapy with docetaxel for NSCLC\n* Receiving systemic steroid therapy within 3 days prior to the first dose of study treatment or receiving any other form of immunosuppressive medication\n* Currently participating or has participated in a study using an investigational antineoplastic agent or device within 30 days of first dose\n* Expected to require any other form of systemic or localized antineoplastic therapy while on trial\n* History of allogeneic tissue/solid organ transplant\n* Prior systemic cytotoxic chemotherapy, antineoplastic biological therapy (e.g., cetuximab), major surgery within 3 weeks of the first dose of study drug; received thoracic radiation therapy of \\>30 Gy within 6 months of the first dose of study drug; received prior tyrosine kinase inhibitor therapy or completed palliative radiotherapy within 7 days of the first dose of study drug\n* Prior therapy with an anti-programmed cell death (PD)-1, anti-PD-L1, anti-PD-L2, anti-tumor necrosis factor CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways), or took part in another pembrolizumab trial\n* Known history of prior malignancy, with the exception of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, or in situ cervical cancer, and has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy\n* Known active central nervous system (CNS) metastases and/or carcinomatous meningitis\n* Active autoimmune disease, or a documented history of autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents\n* Interstitial lung disease, or history of pneumonitis requiring systemic steroids for treatment\n* Known history or active human immunodeficiency virus (HIV), hepatitis B, or hepatitis C\n* Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial through 120 days after last dose of pembrolizumab or 180 days after last dose of docetaxel'}, 'identificationModule': {'nctId': 'NCT01905657', 'briefTitle': 'Study of Two Doses of Pembrolizumab (MK-3475) Versus Docetaxel in Previously Treated Participants With Non-Small Cell Lung Cancer (MK-3475-010/KEYNOTE-010)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Phase II/III Randomized Trial of Two Doses of MK-3475 (SCH900475) Versus Docetaxel in Previously Treated Subjects With Non-Small Cell Lung Cancer', 'orgStudyIdInfo': {'id': '3475-010'}, 'secondaryIdInfos': [{'id': '2012-004391-19', 'type': 'EUDRACT_NUMBER'}, {'id': '132355', 'type': 'REGISTRY', 'domain': 'Japic-CTI'}, {'id': 'MK-3475-010', 'type': 'OTHER', 'domain': 'Merck'}, {'id': 'KEYNOTE-010', 'type': 'OTHER', 'domain': 'Merck'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pembrolizumab 2 mg/kg', 'description': 'Participants received pembrolizumab 2 mg/kg intravenously (IV) over 30 minutes Q3W for up to 2 years.', 'interventionNames': ['Biological: Pembrolizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Pembrolizumab 10 mg/kg', 'description': 'Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years.', 'interventionNames': ['Biological: Pembrolizumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Docetaxel 75 mg/m^2', 'description': 'Participants received docetaxel 75 mg/m\\^2 IV over 1 hour Q3W for up to 2 years.', 'interventionNames': ['Drug: Docetaxel']}], 'interventions': [{'name': 'Pembrolizumab', 'type': 'BIOLOGICAL', 'otherNames': ['MK-3475', 'KEYTRUDA®'], 'description': 'IV infusion', 'armGroupLabels': ['Pembrolizumab 10 mg/kg', 'Pembrolizumab 2 mg/kg']}, {'name': 'Docetaxel', 'type': 'DRUG', 'otherNames': ['TAXOTERE®'], 'description': 'IV infusion', 'armGroupLabels': ['Docetaxel 75 mg/m^2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'url': 'http://engagezone.msd.com/ds_documentation.php', 'ipdSharing': 'YES', 'description': 'http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}