Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-02-23 @ 4:54 AM
Study NCT ID:
NCT02362594
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-15
First Post:
2015-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Pembrolizumab (MK-3475) Versus Placebo After Complete Resection of High-Risk Stage III Melanoma (MK-3475-054/1325-MG/KEYNOTE-054)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Australia', 'Austria', 'Belgium', 'Canada', 'Denmark', 'Finland', 'France', 'Germany', 'Israel', 'Italy', 'Japan', 'Netherlands', 'New Zealand', 'Norway', 'Poland', 'Portugal', 'Russia', 'Serbia', 'Spain', 'Sweden', 'Switzerland', 'United Kingdom', 'United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C582435', 'term': 'pembrolizumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme LLC'}, 'certainAgreement': {'otherDetails': 'All draft publications, including abstracts or detailed summaries of any proposed presentations, must be submitted to the Sponsor at the earliest practicable time for review, not less than 30 days before submission or presentation unless otherwise set forth in the clinical trial agreement. Sponsor shall have the right to delete any confidential information contained in any proposed presentation or abstract and may delay publication for up to 60 days for purposes of filing a patent application.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 29 months (through database cut-off date of 02-Oct-2017)', 'description': 'All-Cause Mortality was reported for all randomized participants in Part 1.\n\nSerious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.', 'eventGroups': [{'id': 'EG000', 'title': 'Pembrolizumab', 'description': 'In Part 1, participants received pembrolizumab 200 mg IV as post-surgery therapy Q3W for up to 1 year.', 'otherNumAtRisk': 509, 'deathsNumAtRisk': 514, 'otherNumAffected': 443, 'seriousNumAtRisk': 509, 'deathsNumAffected': 25, 'seriousNumAffected': 128}, {'id': 'EG001', 'title': 'Placebo', 'description': 'In Part 1, participants received placebo IV as post-surgery therapy Q3W.', 'otherNumAtRisk': 502, 'deathsNumAtRisk': 505, 'otherNumAffected': 409, 'seriousNumAtRisk': 502, 'deathsNumAffected': 35, 'seriousNumAffected': 82}], 'otherEvents': [{'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 61, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 93, 'numAffected': 75}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 40, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 37, 'numAffected': 31}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 37, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 32, 'numAffected': 29}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 238, 'numAffected': 140}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 234, 'numAffected': 129}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 32, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 112, 'numAffected': 88}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 103, 'numAffected': 73}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 55, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 25, 'numAffected': 22}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 93, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 71, 'numAffected': 42}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 247, 'numAffected': 168}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 232, 'numAffected': 168}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 73, 'numAffected': 55}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 47, 'numAffected': 38}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 54, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 26, 'numAffected': 25}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 49, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 39, 'numAffected': 30}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 41, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 30, 'numAffected': 24}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 69, 'numAffected': 55}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 64, 'numAffected': 39}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 96, 'numAffected': 63}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 117, 'numAffected': 82}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 40, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 15, 'numAffected': 13}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 130, 'numAffected': 79}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 98, 'numAffected': 72}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 37, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 69, 'numAffected': 54}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 40, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 29, 'numAffected': 25}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 26, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 34, 'numAffected': 30}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 29, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 38, 'numAffected': 31}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 135, 'numAffected': 95}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 126, 'numAffected': 93}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 88, 'numAffected': 70}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 66, 'numAffected': 55}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 50, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 26, 'numAffected': 25}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 138, 'numAffected': 99}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 74, 'numAffected': 58}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 90, 'numAffected': 67}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 51, 'numAffected': 43}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 44, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 26, 'numAffected': 24}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 178, 'numAffected': 74}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 209, 'numAffected': 77}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Lymphoedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 28, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 37, 'numAffected': 36}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Autoimmune pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Myocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Adrenocortical insufficiency acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Hypophysitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Hypopituitarism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Secondary adrenocortical insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Thyroiditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Conjunctivitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Aptyalism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Autoimmune colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 9, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Food poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Large intestine perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Oesophageal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Oral lichen planus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Small intestinal perforation', 'stats': 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unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Leydig cell tumour of the testis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Malignant melanoma in situ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Mantle cell lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Melanocytic naevus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Meningioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Metastases to central nervous system', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Nodular melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Rectal adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Renal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 10, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Squamous cell carcinoma of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Superficial spreading melanoma stage unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Thyroid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Carotid artery aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Facial paralysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Myasthenia gravis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Autoimmune nephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Glomerulosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Nephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 4, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Renal colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Tubulointerstitial nephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Drug reaction with eosinophilia and systemic symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Lichenoid keratosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Psoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Appendicectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Lymphoedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Venous thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 509, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 502, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Part 1: Percentage of Participants With Recurrence-Free Survival (RFS) At 6 Months Among All Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '514', 'groupId': 'OG000'}, {'value': '505', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab', 'description': 'In Part 1, participants received pembrolizumab 200 mg IV as post-surgery therapy Q3W for up to 1 year.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'In Part 1, participants received placebo IV as post-surgery therapy Q3W.'}], 'classes': [{'categories': [{'measurements': [{'value': '82.2', 'groupId': 'OG000', 'lowerLimit': '78.6', 'upperLimit': '85.3'}, {'value': '73.3', 'groupId': 'OG001', 'lowerLimit': '69.2', 'upperLimit': '77.0'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '98.4', 'paramValue': '0.57', 'ciLowerLimit': '0.43', 'ciUpperLimit': '0.74', 'pValueComment': 'One-sided p-value based on log-rank test.', 'groupDescription': 'Comparison of RFS time-to-event distribution between the 2 treatment arms was based on Cox regression model with treatment as a covariate stratified by stage (IIIA \\[\\>1 mm metastasis\\] vs. IIIB vs. IIIC 1-3 nodes vs. IIIC ≥4 nodes) as indicated at randomization.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'RFS was defined as the time between the date of randomization and the date of first melanoma recurrence (local, regional, distant metastasis) or death (whatever the cause), whichever occurred first. For participants who remained alive and whose disease had not recurred, RFS was censored on the date of last visit/contact with disease assessments. The percentage of participants with RFS at Month 6 was reported for all participants in both treatment arms of Part 1.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants in Part 1.'}, {'type': 'PRIMARY', 'title': 'Part 1: Percentage of Participants With Recurrence-Free Survival (RFS) At 6 Months Among Participants With PD-L1-positive Tumor Expression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '428', 'groupId': 'OG000'}, {'value': '425', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab', 'description': 'In Part 1, participants received pembrolizumab 200 mg IV as post-surgery therapy Q3W for up to 1 year.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'In Part 1, participants received placebo IV as post-surgery therapy Q3W.'}], 'classes': [{'categories': [{'measurements': [{'value': '83.8', 'groupId': 'OG000', 'lowerLimit': '80.0', 'upperLimit': '87.0'}, {'value': '75.4', 'groupId': 'OG001', 'lowerLimit': '71.0', 'upperLimit': '79.2'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95.0', 'paramValue': '0.54', 'ciLowerLimit': '0.42', 'ciUpperLimit': '0.69', 'pValueComment': 'One-sided p-value based on log-rank test.', 'groupDescription': 'Comparison of RFS time-to-event distribution between the 2 treatment arms (PD-L1-positive participants) was based on Cox regression model with treatment as a covariate stratified by stage (IIIA \\[\\>1 mm metastasis\\] vs. IIIB vs. IIIC 1-3 nodes vs. IIIC ≥4 nodes) as indicated at randomization.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'RFS was defined as the time between the date of randomization and the date of first melanoma recurrence (local, regional, distant metastasis) or death (whatever the cause), whichever occurred first. For participants who remained alive and whose disease had not recurred, RFS was censored on the date of last visit/contact with disease assessments. The percentage of participants with RFS at Month 6 was reported for all participants with PD-L1-positive tumors in both treatment arms of Part 1.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants in Part 1 with PD-L1-positive tumors.'}, {'type': 'SECONDARY', 'title': 'Distant Metastases-free Survival (DMFS) in All Participants', 'timeFrame': 'Up to approximately 11 years', 'description': 'DMFS will be defined as the time between the date of randomization and the date of first distant metastasis or date of death (whatever the cause), whichever occurs first. For participants who remain alive and distant metastasis-free, DMFS will be censored on the date of last visit/contact with disease assessments. The percentage of participants with DMFS will be reported for all participants in both treatment arms.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2026-11'}, {'type': 'SECONDARY', 'title': 'Distant Metastases-free Survival (DMFS) for Participants With PD-L1-positive Tumor Expression', 'timeFrame': 'Up to approximately 11 years', 'description': 'Description:\n\nDMFS will be defined as the time between the date of randomization and the date of first distant metastasis or date of death (whatever the cause), whichever occurs first. For participants who remain alive and distant metastasis-free, DMFS will be censored on the date of last visit/contact with disease assessments. The percentage of participants with DMFS will be reported for all participants with PD-L1-positive tumors in both treatment arms.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2026-11'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS) for All Participants', 'timeFrame': 'Up to approximately 11 years', 'description': 'OS will be defined as the time from the date of randomization to the date of death, whatever the cause. The follow-up of participants still alive will be censored at the moment of last visit/contact. OS will be reported for all participants in both treatment arms.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2026-11'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS) for Participants With PD-L1-positive Tumor Expression', 'timeFrame': 'Up to approximately 11 years', 'description': 'OS will be defined as the time from the date of randomization to the date of death, whatever the cause. The follow-up of participants still alive will be censored at the moment of last visit/contact. OS will be reported for all participants with PD-L1-positive tumors in both treatment arms.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2026-11'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Experienced At Least 1 Adverse Event (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '509', 'groupId': 'OG000'}, {'value': '502', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab', 'description': 'In Part 1, participants received pembrolizumab 200 mg IV as post-surgery therapy Q3W for up to 1 year.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'In Part 1, participants received placebo IV as post-surgery therapy Q3W.'}], 'classes': [{'categories': [{'measurements': [{'value': '475', 'groupId': 'OG000'}, {'value': '453', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 22 months', 'description': 'An AE is defined as "any untoward medical occurrence in a participant which does not necessarily have to have a causal relationship with this treatment". An AE can therefore be any unfavorable and unintended signs (such as rash or enlarged liver), symptoms (such as nausea or chest pain), an abnormal laboratory finding (including results of blood tests, x-rays or scans) or a disease temporarily associated with the use of the protocol treatment, whether or not considered related to the investigational medicinal product. The number of participants who experienced at least 1 AE was reported for all participants in each treatment arm.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants in Part 1 who received at least 1 dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '509', 'groupId': 'OG000'}, {'value': '502', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab', 'description': 'In Part 1, participants received pembrolizumab 200 mg IV as post-surgery therapy Q3W for up to 1 year.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'In Part 1, participants received placebo IV as post-surgery therapy Q3W.'}], 'classes': [{'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 22 months', 'description': 'An AE is defined as "any untoward medical occurrence in a participant which does not necessarily have to have a causal relationship with this treatment". An AE can therefore be any unfavorable and unintended signs (such as rash or enlarged liver), symptoms (such as nausea or chest pain), an abnormal laboratory finding (including results of blood tests, x-rays or scans) or a disease temporarily associated with the use of the protocol treatment, whether or not considered related to the investigational medicinal product. The number of participants who discontinued study treatment due to an AE was reported for all participants in each treatment arm.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants in Part 1 who received at least 1 dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Clearance (CL) of Pembrolizumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab', 'description': 'In Part 1, participants received pembrolizumab 200 mg IV as post-surgery therapy Q3W for up to 1 year.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'In Part 1, participants received placebo IV as post-surgery therapy Q3W.'}], 'timeFrame': 'Pre-dose on Day 1 of Cycles 1, 2, 4, 6, and 8, and then Day 1 of cycle for every 4 cycles afterwards (up to approximately 16 months). Each cycle is 3 weeks.', 'description': 'Blood samples were to be collected at pre-specified time points and plasma isolated for analysis of pembrolizumab CL, defined as the volume of plasma from which pembrolizumab is eliminated per unit time following IV pembrolizumab administration. Samples were not collected and this analysis was not performed.', 'reportingStatus': 'POSTED', 'populationDescription': 'As pre-specified by the protocol, pembrolizumab CL was not analyzed as planned and no data were collected since by the time of the interim analysis, pembrolizumab pharmacokinetics (PK) in melanoma patients had been well characterized and found to be consistent with the overall clinical pharmacology of pembrolizumab characterized across indications.'}, {'type': 'SECONDARY', 'title': 'Volume of Distribution (V) of Pembrolizumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab', 'description': 'In Part 1, participants received pembrolizumab 200 mg IV as post-surgery therapy Q3W for up to 1 year.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'In Part 1, participants received placebo IV as post-surgery therapy Q3W.'}], 'timeFrame': 'Pre-dose on Day 1 of Cycles 1, 2, 4, 6, and 8, and then Day 1 of cycle for every 4 cycles afterwards (up to approximately 16 months). Each cycle is 3 weeks.', 'description': 'Blood samples were to be collected at pre-specified time points and plasma isolated for analysis of pembrolizumab V, defined as the theoretical volume that would be necessary to contain the total amount of administered pembrolizumab at the same concentration that it is observed in the blood plasma. Samples were not collected and this analysis was not performed.', 'reportingStatus': 'POSTED', 'populationDescription': 'As pre-specified by the protocol, pembrolizumab V was not analyzed as planned and no data were collected since by the time of the interim analysis, pembrolizumab PK in melanoma patients had been well characterized and found to be consistent with the overall clinical pharmacology of pembrolizumab characterized across indications.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Positive for Anti-Drug Antibodies (ADA) After Pembrolizumab Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '495', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pembrolizumab', 'description': 'In Part 1, participants received pembrolizumab 200 mg IV as post-surgery therapy Q3W for up to 1 year.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'In Part 1, participants received placebo IV as post-surgery therapy Q3W.'}], 'classes': [{'title': 'Negative', 'categories': [{'measurements': [{'value': '473', 'groupId': 'OG000'}]}]}, {'title': 'Non-Treatment emergent positive', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Treatment emergent positive', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Pre-dose on Day 1 of Cycles 1, 2, 4, 6, and 8, and then Day 1 of cycle for every 4 cycles afterwards (up to approximately 16 months). Each cycle is 3 weeks.', 'description': 'Pre- and post-baseline serum samples from participants treated with pembrolizumab were analyzed for ADA by means of a neutralizing antibody assay which assessed the ability of ADA to block (neutralize) binding of pembrolizumab to Programmed Cell Death-1 (PD-1) protein. Overall immunogenicity was defined as the number of treatment emergent positive participants based on the total number of evaluable participants (treatment emergent positive, non-treatment emergent positive and negative immunogenicity status).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants in Part 1 who had at least one ADA sample available after treatment with pembrolizumab and who had treatment emergent positive, non-treatment emergent positive, or negative immunogenicity status. Participants receiving Placebo treatment in Part 1 were not analyzed for ADA.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pembrolizumab', 'description': 'In Part 1, participants received pembrolizumab 200 mg intravenously (IV) as post-surgery therapy every 3 weeks (Q3W) for up to 1 year.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'In Part 1, participants received placebo IV as post-surgery therapy Q3W.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '514'}, {'groupId': 'FG001', 'numSubjects': '505'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '509'}, {'groupId': 'FG001', 'numSubjects': '502'}]}, {'type': 'Continuing Part 1 Adjuvant Therapy', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'comment': 'Completed Part 1 Adjuvant Therapy', 'achievements': [{'groupId': 'FG000', 'numSubjects': '264'}, {'groupId': 'FG001', 'numSubjects': '280'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '250'}, {'groupId': 'FG001', 'numSubjects': '225'}]}]}], 'preAssignmentDetails': 'As of the 02-Oct-2017 interim database cut-off date, of the 1019 randomized participants in Part 1, 544 had completed Part 1 and 62 were continuing in Part 1. This interim results disclosure is for Part 1 only.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '514', 'groupId': 'BG000'}, {'value': '505', 'groupId': 'BG001'}, {'value': '1019', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Pembrolizumab', 'description': 'In Part 1, participants received pembrolizumab 200 mg IV as post-surgery therapy Q3W for up to 1 year.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'In Part 1, participants received placebo IV as post-surgery therapy Q3W.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '514', 'groupId': 'BG000'}, {'value': '505', 'groupId': 'BG001'}, {'value': '1019', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '53.9', 'spread': '13.6', 'groupId': 'BG000'}, {'value': '53.7', 'spread': '14.2', 'groupId': 'BG001'}, {'value': '53.8', 'spread': '13.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '514', 'groupId': 'BG000'}, {'value': '505', 'groupId': 'BG001'}, {'value': '1019', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '190', 'groupId': 'BG000'}, {'value': '201', 'groupId': 'BG001'}, {'value': '391', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '324', 'groupId': 'BG000'}, {'value': '304', 'groupId': 'BG001'}, {'value': '628', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Programmed Death-Ligand 1 (PD-L1) Tumor Status', 'classes': [{'title': 'PD-L1 Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '514', 'groupId': 'BG000'}, {'value': '505', 'groupId': 'BG001'}, {'value': '1019', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '428', 'groupId': 'BG000'}, {'value': '425', 'groupId': 'BG001'}, {'value': '853', 'groupId': 'BG002'}]}]}, {'title': 'PD-L1 Negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '514', 'groupId': 'BG000'}, {'value': '505', 'groupId': 'BG001'}, {'value': '1019', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}]}]}, {'title': 'Undetermined', 'denoms': [{'units': 'Participants', 'counts': [{'value': '514', 'groupId': 'BG000'}, {'value': '505', 'groupId': 'BG001'}, {'value': '1019', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Tumor PD-L1 status was assessed by immunohistochemistry (IHC) and recorded as positive (≥1% PD-L1 IHC), negative (\\<1% PD-L1 IHC), or undetermined level of expression (indeterminate PD-L1 IHC).', 'unitOfMeasure': 'Participants'}, {'title': 'Melanoma Stage', 'classes': [{'title': 'Stage IIIA (> 1 mm)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '514', 'groupId': 'BG000'}, {'value': '505', 'groupId': 'BG001'}, {'value': '1019', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}]}]}, {'title': 'Stage IIIB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '514', 'groupId': 'BG000'}, {'value': '505', 'groupId': 'BG001'}, {'value': '1019', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '237', 'groupId': 'BG000'}, {'value': '230', 'groupId': 'BG001'}, {'value': '467', 'groupId': 'BG002'}]}]}, {'title': 'Stage IIIC (1-3 LN+)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '514', 'groupId': 'BG000'}, {'value': '505', 'groupId': 'BG001'}, {'value': '1019', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '95', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '188', 'groupId': 'BG002'}]}]}, {'title': 'Stage IIIC (≥4 LN+)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '514', 'groupId': 'BG000'}, {'value': '505', 'groupId': 'BG001'}, {'value': '1019', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '102', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '204', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants were stratified by melanoma stage using the American Joint Committee on Cancer (AJCC) 7th edition stage as follows: Stage IIIA (with \\>1 mm metastasis), Stage IIIB, Stage IIIC with 1-3 positive lymph nodes (LN+), and Stage IIIC with ≥4 LN+.', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '514', 'groupId': 'BG000'}, {'value': '505', 'groupId': 'BG001'}, {'value': '1019', 'groupId': 'BG002'}]}], 'categories': [{'title': 'North America', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}, {'title': 'Europe', 'measurements': [{'value': '341', 'groupId': 'BG000'}, {'value': '336', 'groupId': 'BG001'}, {'value': '677', 'groupId': 'BG002'}]}, {'title': 'Australia/New Zealand', 'measurements': [{'value': '111', 'groupId': 'BG000'}, {'value': '112', 'groupId': 'BG001'}, {'value': '223', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-02-28', 'size': 2021092, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-12-10T11:00', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1019}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-07-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-03', 'studyFirstSubmitDate': '2015-02-09', 'resultsFirstSubmitDate': '2018-12-10', 'studyFirstSubmitQcDate': '2015-02-09', 'lastUpdatePostDateStruct': {'date': '2025-10-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2018-12-10', 'studyFirstPostDateStruct': {'date': '2015-02-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-01-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part 1: Percentage of Participants With Recurrence-Free Survival (RFS) At 6 Months Among All Participants', 'timeFrame': '6 months', 'description': 'RFS was defined as the time between the date of randomization and the date of first melanoma recurrence (local, regional, distant metastasis) or death (whatever the cause), whichever occurred first. For participants who remained alive and whose disease had not recurred, RFS was censored on the date of last visit/contact with disease assessments. The percentage of participants with RFS at Month 6 was reported for all participants in both treatment arms of Part 1.'}, {'measure': 'Part 1: Percentage of Participants With Recurrence-Free Survival (RFS) At 6 Months Among Participants With PD-L1-positive Tumor Expression', 'timeFrame': '6 months', 'description': 'RFS was defined as the time between the date of randomization and the date of first melanoma recurrence (local, regional, distant metastasis) or death (whatever the cause), whichever occurred first. For participants who remained alive and whose disease had not recurred, RFS was censored on the date of last visit/contact with disease assessments. The percentage of participants with RFS at Month 6 was reported for all participants with PD-L1-positive tumors in both treatment arms of Part 1.'}], 'secondaryOutcomes': [{'measure': 'Distant Metastases-free Survival (DMFS) in All Participants', 'timeFrame': 'Up to approximately 11 years', 'description': 'DMFS will be defined as the time between the date of randomization and the date of first distant metastasis or date of death (whatever the cause), whichever occurs first. For participants who remain alive and distant metastasis-free, DMFS will be censored on the date of last visit/contact with disease assessments. The percentage of participants with DMFS will be reported for all participants in both treatment arms.'}, {'measure': 'Distant Metastases-free Survival (DMFS) for Participants With PD-L1-positive Tumor Expression', 'timeFrame': 'Up to approximately 11 years', 'description': 'Description:\n\nDMFS will be defined as the time between the date of randomization and the date of first distant metastasis or date of death (whatever the cause), whichever occurs first. For participants who remain alive and distant metastasis-free, DMFS will be censored on the date of last visit/contact with disease assessments. The percentage of participants with DMFS will be reported for all participants with PD-L1-positive tumors in both treatment arms.'}, {'measure': 'Overall Survival (OS) for All Participants', 'timeFrame': 'Up to approximately 11 years', 'description': 'OS will be defined as the time from the date of randomization to the date of death, whatever the cause. The follow-up of participants still alive will be censored at the moment of last visit/contact. OS will be reported for all participants in both treatment arms.'}, {'measure': 'Overall Survival (OS) for Participants With PD-L1-positive Tumor Expression', 'timeFrame': 'Up to approximately 11 years', 'description': 'OS will be defined as the time from the date of randomization to the date of death, whatever the cause. The follow-up of participants still alive will be censored at the moment of last visit/contact. OS will be reported for all participants with PD-L1-positive tumors in both treatment arms.'}, {'measure': 'Number of Participants Who Experienced At Least 1 Adverse Event (AE)', 'timeFrame': 'Up to 22 months', 'description': 'An AE is defined as "any untoward medical occurrence in a participant which does not necessarily have to have a causal relationship with this treatment". An AE can therefore be any unfavorable and unintended signs (such as rash or enlarged liver), symptoms (such as nausea or chest pain), an abnormal laboratory finding (including results of blood tests, x-rays or scans) or a disease temporarily associated with the use of the protocol treatment, whether or not considered related to the investigational medicinal product. The number of participants who experienced at least 1 AE was reported for all participants in each treatment arm.'}, {'measure': 'Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)', 'timeFrame': 'Up to 22 months', 'description': 'An AE is defined as "any untoward medical occurrence in a participant which does not necessarily have to have a causal relationship with this treatment". An AE can therefore be any unfavorable and unintended signs (such as rash or enlarged liver), symptoms (such as nausea or chest pain), an abnormal laboratory finding (including results of blood tests, x-rays or scans) or a disease temporarily associated with the use of the protocol treatment, whether or not considered related to the investigational medicinal product. The number of participants who discontinued study treatment due to an AE was reported for all participants in each treatment arm.'}, {'measure': 'Clearance (CL) of Pembrolizumab', 'timeFrame': 'Pre-dose on Day 1 of Cycles 1, 2, 4, 6, and 8, and then Day 1 of cycle for every 4 cycles afterwards (up to approximately 16 months). Each cycle is 3 weeks.', 'description': 'Blood samples were to be collected at pre-specified time points and plasma isolated for analysis of pembrolizumab CL, defined as the volume of plasma from which pembrolizumab is eliminated per unit time following IV pembrolizumab administration. Samples were not collected and this analysis was not performed.'}, {'measure': 'Volume of Distribution (V) of Pembrolizumab', 'timeFrame': 'Pre-dose on Day 1 of Cycles 1, 2, 4, 6, and 8, and then Day 1 of cycle for every 4 cycles afterwards (up to approximately 16 months). Each cycle is 3 weeks.', 'description': 'Blood samples were to be collected at pre-specified time points and plasma isolated for analysis of pembrolizumab V, defined as the theoretical volume that would be necessary to contain the total amount of administered pembrolizumab at the same concentration that it is observed in the blood plasma. Samples were not collected and this analysis was not performed.'}, {'measure': 'Number of Participants Positive for Anti-Drug Antibodies (ADA) After Pembrolizumab Treatment', 'timeFrame': 'Pre-dose on Day 1 of Cycles 1, 2, 4, 6, and 8, and then Day 1 of cycle for every 4 cycles afterwards (up to approximately 16 months). Each cycle is 3 weeks.', 'description': 'Pre- and post-baseline serum samples from participants treated with pembrolizumab were analyzed for ADA by means of a neutralizing antibody assay which assessed the ability of ADA to block (neutralize) binding of pembrolizumab to Programmed Cell Death-1 (PD-1) protein. Overall immunogenicity was defined as the number of treatment emergent positive participants based on the total number of evaluable participants (treatment emergent positive, non-treatment emergent positive and negative immunogenicity status).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Programmed Cell Death-1 (PD-1)', 'Programmed Cell Death 1 (PD1)', 'Programmed Cell Death-Ligand 1 (PD-L1, PDL1)', 'Programmed Cell Death-Ligand 2 (PD-L2, PDL2)'], 'conditions': ['Melanoma']}, 'referencesModule': {'references': [{'pmid': '39146951', 'type': 'DERIVED', 'citation': 'Buhrer E, Kicinski M, Mandala M, Pe M, Long GV, Atkinson V, Blank CU, Haydon A, Dalle S, Khattak A, Carlino MS, Meshcheryakov A, Sandhu S, Puig S, Schadendorf D, Jamal R, Rutkowski P, van den Eertwegh AJM, Coens C, Grebennik D, Krepler C, Robert C, Eggermont AMM. Adjuvant pembrolizumab versus placebo in resected stage III melanoma (EORTC 1325-MG/KEYNOTE-054): long-term, health-related quality-of-life results from a double-blind, randomised, controlled, phase 3 trial. Lancet Oncol. 2024 Sep;25(9):1202-1212. doi: 10.1016/S1470-2045(24)00338-3. Epub 2024 Aug 12.'}, {'pmid': '38319852', 'type': 'DERIVED', 'citation': 'Eggermont AMM, Kicinski M, Blank CU, Mandala M, Long GV, Atkinson V, Dalle S, Haydon A, Meshcheryakov A, Khattak A, Carlino MS, Sandhu S, Larkin J, Puig S, Ascierto PA, Rutkowski P, Schadendorf D, Boers-Sonderen M, Di Giacomo AM, van den Eertwegh AJM, Grob JJ, Gutzmer R, Jamal R, van Akkooi ACJ, Lorigan P, Grebennik D, Krepler C, Marreaud S, Suciu S, Robert C. Five-Year Analysis of Adjuvant Pembrolizumab or Placebo in Stage III Melanoma. NEJM Evid. 2022 Nov;1(11):EVIDoa2200214. doi: 10.1056/EVIDoa2200214. Epub 2022 Sep 10.'}, {'pmid': '35220182', 'type': 'DERIVED', 'citation': 'Kennedy OJ, Kicinski M, Valpione S, Gandini S, Suciu S, Blank CU, Long GV, Atkinson VG, Dalle S, Haydon AM, Meshcheryakov A, Khattak A, Carlino MS, Sandhu S, Larkin J, Puig S, Ascierto PA, Rutkowski P, Schadendorf D, Koornstra R, Hernandez-Aya L, Di Giacomo AM, van den Eertwegh AJM, Grob JJ, Gutzmer R, Jamal R, van Akkooi ACJ, Robert C, Eggermont AMM, Lorigan P, Mandala M. Prognostic and predictive value of beta-blockers in the EORTC 1325/KEYNOTE-054 phase III trial of pembrolizumab versus placebo in resected high-risk stage III melanoma. Eur J Cancer. 2022 Apr;165:97-112. doi: 10.1016/j.ejca.2022.01.017. Epub 2022 Feb 24.'}, {'pmid': '33857414', 'type': 'DERIVED', 'citation': 'Bottomley A, Coens C, Mierzynska J, Blank CU, Mandala M, Long GV, Atkinson VG, Dalle S, Haydon AM, Meshcheryakov A, Khattak A, Carlino MS, Sandhu S, Puig S, Ascierto PA, Larkin J, Lorigan PC, Rutkowski P, Schadendorf D, Koornstra R, Hernandez-Aya L, Di Giacomo AM, van den Eertwegh AJM, Grob JJ, Gutzmer R, Jamal R, van Akkooi ACJ, Krepler C, Ibrahim N, Marreaud S, Kicinski M, Suciu S, Robert C, Eggermont AMM; EORTC Melanoma Group. Adjuvant pembrolizumab versus placebo in resected stage III melanoma (EORTC 1325-MG/KEYNOTE-054): health-related quality-of-life results from a double-blind, randomised, controlled, phase 3 trial. Lancet Oncol. 2021 May;22(5):655-664. doi: 10.1016/S1470-2045(21)00081-4. Epub 2021 Apr 12.'}, {'pmid': '33857412', 'type': 'DERIVED', 'citation': 'Eggermont AMM, Blank CU, Mandala M, Long GV, Atkinson VG, Dalle S, Haydon AM, Meshcheryakov A, Khattak A, Carlino MS, Sandhu S, Larkin J, Puig S, Ascierto PA, Rutkowski P, Schadendorf D, Koornstra R, Hernandez-Aya L, Di Giacomo AM, van den Eertwegh AJM, Grob JJ, Gutzmer R, Jamal R, Lorigan PC, van Akkooi ACJ, Krepler C, Ibrahim N, Marreaud S, Kicinski M, Suciu S, Robert C; EORTC Melanoma Group. Adjuvant pembrolizumab versus placebo in resected stage III melanoma (EORTC 1325-MG/KEYNOTE-054): distant metastasis-free survival results from a double-blind, randomised, controlled, phase 3 trial. Lancet Oncol. 2021 May;22(5):643-654. doi: 10.1016/S1470-2045(21)00065-6. Epub 2021 Apr 12.'}, {'pmid': '32946353', 'type': 'DERIVED', 'citation': 'Eggermont AMM, Blank CU, Mandala M, Long GV, Atkinson VG, Dalle S, Haydon AM, Meshcheryakov A, Khattak A, Carlino MS, Sandhu S, Larkin J, Puig S, Ascierto PA, Rutkowski P, Schadendorf D, Koornstra R, Hernandez-Aya L, Di Giacomo AM, van den Eertwegh AJM, Grob JJ, Gutzmer R, Jamal R, Lorigan PC, van Akkooi ACJ, Krepler C, Ibrahim N, Marreaud S, Kicinski M, Suciu S, Robert C. Longer Follow-Up Confirms Recurrence-Free Survival Benefit of Adjuvant Pembrolizumab in High-Risk Stage III Melanoma: Updated Results From the EORTC 1325-MG/KEYNOTE-054 Trial. J Clin Oncol. 2020 Nov 20;38(33):3925-3936. doi: 10.1200/JCO.20.02110. Epub 2020 Sep 18.'}, {'pmid': '31895407', 'type': 'DERIVED', 'citation': 'Eggermont AMM, Kicinski M, Blank CU, Mandala M, Long GV, Atkinson V, Dalle S, Haydon A, Khattak A, Carlino MS, Sandhu S, Larkin J, Puig S, Ascierto PA, Rutkowski P, Schadendorf D, Koornstra R, Hernandez-Aya L, Di Giacomo AM, van den Eertwegh AJM, Grob JJ, Gutzmer R, Jamal R, Lorigan PC, Krepler C, Ibrahim N, Marreaud S, van Akkooi A, Robert C, Suciu S. Association Between Immune-Related Adverse Events and Recurrence-Free Survival Among Patients With Stage III Melanoma Randomized to Receive Pembrolizumab or Placebo: A Secondary Analysis of a Randomized Clinical Trial. JAMA Oncol. 2020 Apr 1;6(4):519-527. doi: 10.1001/jamaoncol.2019.5570.'}, {'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': '29658430', 'type': 'DERIVED', 'citation': 'Eggermont AMM, Blank CU, Mandala M, Long GV, Atkinson V, Dalle S, Haydon A, Lichinitser M, Khattak A, Carlino MS, Sandhu S, Larkin J, Puig S, Ascierto PA, Rutkowski P, Schadendorf D, Koornstra R, Hernandez-Aya L, Maio M, van den Eertwegh AJM, Grob JJ, Gutzmer R, Jamal R, Lorigan P, Ibrahim N, Marreaud S, van Akkooi ACJ, Suciu S, Robert C. Adjuvant Pembrolizumab versus Placebo in Resected Stage III Melanoma. N Engl J Med. 2018 May 10;378(19):1789-1801. doi: 10.1056/NEJMoa1802357. Epub 2018 Apr 15.'}], 'seeAlsoLinks': [{'url': 'https://www.merckclinicaltrials.com/', 'label': 'Merck Clinical Trials Information'}]}, 'descriptionModule': {'briefSummary': 'This study will assess whether post-surgery therapy with pembrolizumab improves recurrence-free survival (RFS) as compared to placebo for high-risk participants with melanoma (Stage IIIA \\[\\> 1 mm metastasis\\], IIIB and IIIC). The study will also assess whether pembrolizumab improves RFS versus placebo in the subgroup of participants with programmed cell death-ligand 1 (PD-L1)-positive tumor expression. Participants will be stratified for stage of disease and region and then will be randomly assigned to receive either pembrolizumab or placebo as post-surgery therapy in Part 1. In Part 2, participants who experience a disease recurrence are eligible for pembrolizumab treatment (if treated with placebo in Part 1) or pembrolizumab rechallenge (if treated with pembrolizumab in Part 1).', 'detailedDescription': 'As of Amendment 8, enrollment in Part 2 has closed, and an optional pembrolizumab extension study will not be available to participants after study closure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Completely resected Stage III melanoma\n* Tumor tissue available for evaluation of PD-L1 expression\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Adequate organ function\n* No prior therapy for melanoma except surgery for primary melanoma lesions (or previously treated with interferon for thick primary melanomas without evidence of lymph node involvement are eligible)\n* Female participants of childbearing potential should be willing to use adequate methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication\n* Male participants should agree to use an adequate method of birth control starting with the first dose of study therapy through 120 days after the last dose of study medication\n\nExclusion criteria:\n\n* Mucosal or ocular melanoma\n* History of (non-infectious) pneumonitis that required steroids or current pneumonitis\n* History of or current interstitial lung disease\n* History of hematologic or primary solid tumor malignancy, unless no evidence of that disease for 5 years\n* Active autoimmune disease that has required systemic treatment in past 2 years\n* Active infection requiring therapy\n* Unstable hyperthyroidism or hypothyroidism\n* Diagnosis of immunodeficiency\n* Systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication\n* Known history of human immunodeficiency virus (HIV), active Hepatitis B or C\n* Treatment with live vaccine within 30 days prior to the first dose of study medication are not eligible\n* Prior treatment with any anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA4) monoclonal antibody or anti-programmed cell death receptor 1 (PD-1), anti-programmed cell death receptor ligand 1 (PD-L1), or anti-programmed cell death receptor ligand 2 (PD-L2) agent, or prior participation in any Merck pembrolizumab clinical trial\n* Currently participating and receiving study therapy, or participated in a study of an investigational agent and received study therapy or used an investigation device within 4 weeks of the first dose of study medication\n* Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of study medication\n* Participant is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling or child) who is investigational site or Sponsor staff directly involved with this trial without prospective Institutional Review Board approval (by chair or designee) is given'}, 'identificationModule': {'nctId': 'NCT02362594', 'briefTitle': 'Study of Pembrolizumab (MK-3475) Versus Placebo After Complete Resection of High-Risk Stage III Melanoma (MK-3475-054/1325-MG/KEYNOTE-054)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'Adjuvant Immunotherapy With Anti-PD-1 Monoclonal Antibody Pembrolizumab (MK-3475) Versus Placebo After Complete Resection of High-risk Stage III Melanoma: A Randomized, Double- Blind Phase 3 Trial of the EORTC Melanoma Group', 'orgStudyIdInfo': {'id': '3475-054'}, 'secondaryIdInfos': [{'id': '1325-MG', 'type': 'OTHER', 'domain': 'European Organisation for Research and Treatment of Cancer'}, {'id': '163277', 'type': 'REGISTRY', 'domain': 'JAPIC-CTI'}, {'id': 'KEYNOTE-054', 'type': 'OTHER', 'domain': 'MSD'}, {'id': 'MK-3475-054', 'type': 'OTHER', 'domain': 'MSD'}, {'id': '2023-509136-25-00', 'type': 'REGISTRY', 'domain': 'EU CT'}, {'id': 'U1111-1309-6016', 'type': 'REGISTRY', 'domain': 'UTN'}, {'id': '2014-004944-37', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pembrolizumab', 'description': 'In Part 1, participants receive pembrolizumab 200 mg intravenously (IV) as post-surgery therapy every 3 weeks (Q3W) for up to 1 year. During Part 2, participants with documented recurrence may receive optional re-treatment with pembrolizumab Q3W for up to 2 years or disease progression.', 'interventionNames': ['Biological: pembrolizumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'In Part 1, participants receive placebo IV as post-surgery therapy Q3W. During Part 2, participants with documented recurrence who received placebo in Part 1 may receive optional treatment with pembrolizumab Q3W for up to 2 years or disease progression.', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'pembrolizumab', 'type': 'BIOLOGICAL', 'otherNames': ['KEYTRUDA®', 'MK-3475', 'SCH 900475'], 'description': 'Pembrolizumab 200 mg administered intravenously (IV) on Day 1 of each 21-day cycle', 'armGroupLabels': ['Pembrolizumab']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Normal saline solution administered IV on Day 1 of each 21-day cycle', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'url': 'https://externaldatasharing-msd.com/', 'ipdSharing': 'YES', 'description': 'https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'European Organisation for Research and Treatment of Cancer', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}