Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-02-20 @ 4:43 PM
Study NCT ID:
NCT03924869
Status:
TERMINATED
Last Update Posted:
2025-12-11
First Post:
2019-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety Study of Stereotactic Body Radiotherapy (SBRT) With or Without Pembrolizumab (MK-3475) in Adults With Unresected Stage I or II Non-Small Cell Lung Cancer (NSCLC) (MK-3475-867/KEYNOTE-867)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'D016634', 'term': 'Radiosurgery'}, {'id': 'C582435', 'term': 'pembrolizumab'}], 'ancestors': [{'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013238', 'term': 'Stereotaxic Techniques'}, {'id': 'D019635', 'term': 'Neurosurgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@msd.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme LLC'}, 'certainAgreement': {'otherDetails': 'The Sponsor will comply with the requirements for publication of study results, and will generally support publication of multicenter studies only in their entirety and not as individual site data. In this case, a coordinating investigator will be designated by mutual agreement. If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to approximately 64 months', 'description': 'All-Cause Mortality reported for all randomized participants.\n\nSerious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment. Per protocol, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug were excluded as AEs.', 'eventGroups': [{'id': 'EG000', 'title': 'Pembrolizumab + SBRT', 'description': 'Participants received SBRT once every 3 days for 3, 4, 5, or 8 fractions (dependent on tumor type/location; 45-70 Gray \\[Gy\\] total) over approximately 2 weeks PLUS pembrolizumab 200 mg via IV infusion once every 3 weeks for up to 17 cycles (up to approximately 1 year). Each cycle was 21 days.', 'otherNumAtRisk': 226, 'deathsNumAtRisk': 227, 'otherNumAffected': 198, 'seriousNumAtRisk': 226, 'deathsNumAffected': 76, 'seriousNumAffected': 90}, {'id': 'EG001', 'title': 'Placebo + SBRT', 'description': 'Participants received SBRT once every 3 days for 3, 4, 5, or 8 fractions (dependent on tumor type/location; 45-70 Gy total) over approximately 2 weeks PLUS placebo (normal saline solution) via IV infusion once every 3 weeks for up to 17 cycles (up to approximately 1 year). Each cycle was 21 days.', 'otherNumAtRisk': 218, 'deathsNumAtRisk': 221, 'otherNumAffected': 176, 'seriousNumAtRisk': 218, 'deathsNumAffected': 63, 'seriousNumAffected': 74}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 32, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 18, 'numAffected': 15}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 41, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 23, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 23, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 52, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 43, 'numAffected': 31}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 22, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 30, 'numAffected': 25}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 20, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 11, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 22, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 22, 'numAffected': 18}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 18, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 22, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 61, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 48, 'numAffected': 43}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 17, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 17, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 18, 'numAffected': 16}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 14, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 16, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 20, 'numAffected': 16}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Radiation pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 22, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 20, 'numAffected': 19}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 23, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 18, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 28, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 25, 'numAffected': 20}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 27, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 24, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 11, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 49, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 17, 'numAffected': 16}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 19, 'numAffected': 18}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 17, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 14, 'numAffected': 13}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 14, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 15, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 22, 'numAffected': 19}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 20, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 39, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 46, 'numAffected': 39}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 47, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 42, 'numAffected': 39}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 19, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 9, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 14, 'numAffected': 13}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 44, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 35, 'numAffected': 21}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 53, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 20, 'numAffected': 16}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 15, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Aplasia pure red cell', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Cardiac failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Dilated cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Myocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Adrenal insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Immune-mediated hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 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(incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Small cell lung cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Encephalitis autoimmune', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hydrocephalus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': "Parkinson's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Parkinsonism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Disorientation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Mania', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Urinary tract obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Bronchopneumopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 24, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Immune-mediated lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Lung disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Decubitus ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Aortic aneurysm rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 226, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 218, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Event-free Survival (EFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SBRT + Pembrolizumab', 'description': 'Participants received SBRT once every 3 days for 3, 4, 5, or 8 fractions (dependent on tumor type/location; 45-70 Gray \\[Gy\\] total) over approximately 2 weeks PLUS pembrolizumab 200 mg via IV infusion once every 3 weeks for up to 17 cycles (up to approximately 1 year). Each cycle was 21 days.'}, {'id': 'OG001', 'title': 'SBRT + Placebo', 'description': 'Participants received SBRT once every 3 days for 3, 4, 5, or 8 fractions (dependent on tumor type/location; 45-70 Gy total) over approximately 2 weeks PLUS placebo (normal saline solution) via IV infusion once every 3 weeks for up to 17 cycles (up to approximately 1 year). Each cycle was 21 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '31.2', 'groupId': 'OG000', 'lowerLimit': '22.5', 'upperLimit': '39.1'}, {'value': '28.3', 'groupId': 'OG001', 'lowerLimit': '19.8', 'upperLimit': '33.1'}]}]}], 'analyses': [{'pValue': '0.29320', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.92', 'ciLowerLimit': '0.69', 'ciUpperLimit': '1.24', 'pValueComment': '1-sided p-value based on log-rank test stratified by Disease Stage, ECOG Performance Status, Geographic Region of Enrollment Site, and Reason For Not Receiving Surgery.', 'groupDescription': 'Hazard ratio and 95% confidence intervals (CIs) were based on Cox regression model with Efron\'s method of tie handling with treatment as a covariate, stratified by Disease Stage (Stage I versus Stage II), ECOG Performance Status (0 or 1 versus 2), Geographic Region of Enrollment Site (East Asia versus non-East Asia), and Reason For Not Receiving Surgery ("medically inoperable" versus "refused surgery").', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approximately 56.8 months', 'description': 'EFS was defined as the time from randomization to the first occurrence of any of the following events: 1) local, regional, or distant recurrence of disease as assessed by radiographic recurrence by blinded independent central review (BICR), positive pathology by local assessment, physical examination by local assessment confirmed by positive pathology and/or radiographic recurrence by BICR, OR 2) death due to any cause. EFS was reported for each arm.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants were analyzed according to the treatment arm they were randomized to.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SBRT + Pembrolizumab', 'description': 'Participants received SBRT once every 3 days for 3, 4, 5, or 8 fractions (dependent on tumor type/location; 45-70 Gray \\[Gy\\] total) over approximately 2 weeks PLUS pembrolizumab 200 mg via IV infusion once every 3 weeks for up to 17 cycles (up to approximately 1 year). Each cycle was 21 days.'}, {'id': 'OG001', 'title': 'SBRT + Placebo', 'description': 'Participants received SBRT once every 3 days for 3, 4, 5, or 8 fractions (dependent on tumor type/location; 45-70 Gy total) over approximately 2 weeks PLUS placebo (normal saline solution) via IV infusion once every 3 weeks for up to 17 cycles (up to approximately 1 year). Each cycle was 21 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '54.7', 'comment': 'NA = Kaplan-Meier estimate for OS upper 95% confidence limit was not reached at time of data cut-off due to an insufficient number of participants with an event.', 'groupId': 'OG000', 'lowerLimit': '33.5', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'NA = Kaplan-Meier estimates for median OS and OS upper 95% confidence limit were not reached at time of data cut-off due to an insufficient number of participants with an event.', 'groupId': 'OG001', 'lowerLimit': '44.4', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.93971', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.33', 'ciLowerLimit': '0.93', 'ciUpperLimit': '1.90', 'pValueComment': '1-sided p-value based on log-rank test stratified by Disease Stage, ECOG Performance Status, Geographic Region of Enrollment Site, and Reason For Not Receiving Surgery.', 'groupDescription': 'Hazard ratio and 95% CIs were based on Cox regression model with Efron\'s method of tie handling with treatment as a covariate, stratified by Disease Stage (Stage I versus Stage II), ECOG Performance Status (0 or 1 versus 2), Geographic Region of Enrollment Site (East Asia versus non-East Asia), and Reason for Not Receiving Surgery ("medically inoperable" versus "refused surgery").', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Per protocol, since the EFS null hypothesis was not rejected, the OS hypothesis was not formally tested and the p-value should be considered nominal.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approximately 56.8 months', 'description': 'OS was defined as the time from date of randomization to date of death from any cause. OS was reported for each arm.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants were analyzed according to the treatment arm they were randomized to.'}, {'type': 'SECONDARY', 'title': 'Time to Death or Distant Metastases (TDDM)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'OG000'}, {'value': '221', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SBRT + Pembrolizumab', 'description': 'Participants received SBRT once every 3 days for 3, 4, 5, or 8 fractions (dependent on tumor type/location; 45-70 Gray \\[Gy\\] total) over approximately 2 weeks PLUS pembrolizumab 200 mg via IV infusion once every 3 weeks for up to 17 cycles (up to approximately 1 year). Each cycle was 21 days.'}, {'id': 'OG001', 'title': 'SBRT + Placebo', 'description': 'Participants received SBRT once every 3 days for 3, 4, 5, or 8 fractions (dependent on tumor type/location; 45-70 Gy total) over approximately 2 weeks PLUS placebo (normal saline solution) via IV infusion once every 3 weeks for up to 17 cycles (up to approximately 1 year). Each cycle was 21 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '39.1', 'comment': 'NA = Kaplan-Meier estimate for TDDM upper 95% confidence limit was not reached at time of data cut-off due to an insufficient number of participants with an event.', 'groupId': 'OG000', 'lowerLimit': '30.5', 'upperLimit': 'NA'}, {'value': '41.3', 'comment': 'NA = Kaplan-Meier estimate for TDDM upper 95% confidence limit was not reached at time of data cut-off due to an insufficient number of participants with an event.', 'groupId': 'OG001', 'lowerLimit': '31.1', 'upperLimit': 'NA'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.02', 'ciLowerLimit': '0.74', 'ciUpperLimit': '1.42', 'pValueComment': 'Per protocol, there was no hypothesis pre-specified for TDDM to be formally tested.', 'groupDescription': 'Hazard ratio and 95% CIs were based on Cox regression model with Efron\'s method of tie handling with treatment as a covariate, stratified by Disease Stage (Stage I versus Stage II), ECOG Performance Status (0 or 1 versus 2), Geographic Region of Enrollment Site (East Asia versus non-East Asia), and Reason for Not Receiving Surgery ("medically inoperable" versus "refused surgery").', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to approximately 56.8 months', 'description': 'TTDM was defined as the time from randomization to the first documented distant metastases or death from any cause, whichever occurred first. The TDDM was reported for each arm.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants were analyzed according to the treatment arm they were randomized to.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Experienced an Adverse Event (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '226', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SBRT + Pembrolizumab', 'description': 'Participants received SBRT once every 3 days for 3, 4, 5, or 8 fractions (dependent on tumor type/location; 45-70 Gray \\[Gy\\] total) over approximately 2 weeks PLUS pembrolizumab 200 mg via IV infusion once every 3 weeks for up to 17 cycles (up to approximately 1 year). Each cycle was 21 days.'}, {'id': 'OG001', 'title': 'SBRT + Placebo', 'description': 'Participants received SBRT once every 3 days for 3, 4, 5, or 8 fractions (dependent on tumor type/location; 45-70 Gy total) over approximately 2 weeks PLUS placebo (normal saline solution) via IV infusion once every 3 weeks for up to 17 cycles (up to approximately 1 year). Each cycle was 21 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '217', 'groupId': 'OG000'}, {'value': '200', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to approximately 64 months', 'description': 'An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experienced an AE were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all participants 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': '226', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SBRT + Pembrolizumab', 'description': 'Participants received SBRT once every 3 days for 3, 4, 5, or 8 fractions (dependent on tumor type/location; 45-70 Gray \\[Gy\\] total) over approximately 2 weeks PLUS pembrolizumab 200 mg via IV infusion once every 3 weeks for up to 17 cycles (up to approximately 1 year). Each cycle was 21 days.'}, {'id': 'OG001', 'title': 'SBRT + Placebo', 'description': 'Participants received SBRT once every 3 days for 3, 4, 5, or 8 fractions (dependent on tumor type/location; 45-70 Gy total) over approximately 2 weeks PLUS placebo (normal saline solution) via IV infusion once every 3 weeks for up to 17 cycles (up to approximately 1 year). Each cycle was 21 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to approximately 16 months', 'description': 'An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinued study treatment due to an AE were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consisted of all participants who received at least 1 dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SBRT + Pembrolizumab', 'description': 'Participants received SBRT once every 3 days for 3, 4, 5, or 8 fractions (dependent on tumor type/location; 45-70 Gray \\[Gy\\] total) over approximately 2 weeks PLUS pembrolizumab 200 mg via IV infusion once every 3 weeks for up to 17 cycles (up to approximately 1 year). Each cycle was 21 days.'}, {'id': 'OG001', 'title': 'SBRT + Placebo', 'description': 'Participants received SBRT once every 3 days for 3, 4, 5, or 8 fractions (dependent on tumor type/location; 45-70 Gy total) over approximately 2 weeks PLUS placebo (normal saline solution) via IV infusion once every 3 weeks for up to 17 cycles (up to approximately 1 year). Each cycle was 21 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.17', 'groupId': 'OG000', 'lowerLimit': '-5.00', 'upperLimit': '0.66'}, {'value': '-0.96', 'groupId': 'OG001', 'lowerLimit': '-3.78', 'upperLimit': '1.86'}]}]}], 'analyses': [{'pValue': '0.5187', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.21', 'ciLowerLimit': '-4.90', 'ciUpperLimit': '2.48', 'groupDescription': 'Stats:\n\nLS Mean change and 95% CIs were based on a constrained longitudinal data analysis (cLDA) model with the EORTC QLQ-C30 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by Disease Stage (Stage I versus Stage II), ECOG Performance Status (0 or 1 versus 2), Geographic Region of Enrollment Site (East Asia versus non-East Asia), and Reason For Not Receiving Surgery (medically inoperable versus refused surgery).', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and up to 24 weeks', 'description': 'The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" were scored on a 7-point scale (1=Very Poor to 7=Excellent). The combined score of Global Health Status (EORTC QLQ-C30 Item 29) and Quality of Life (EORTC QLQ-C30 Item 30) was computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicates a better outcome. The change from baseline in GHS/QoL combined score was reported for each arm.', 'unitOfMeasure': 'Score on a Scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study intervention and had at least 1 EORTC QLQ-C30 assessment available were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer Module 13 (EORTC QLQ-LC13) Cough (Item 31) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SBRT + Pembrolizumab', 'description': 'Participants received SBRT once every 3 days for 3, 4, 5, or 8 fractions (dependent on tumor type/location; 45-70 Gray \\[Gy\\] total) over approximately 2 weeks PLUS pembrolizumab 200 mg via IV infusion once every 3 weeks for up to 17 cycles (up to approximately 1 year). Each cycle was 21 days.'}, {'id': 'OG001', 'title': 'SBRT + Placebo', 'description': 'Participants received SBRT once every 3 days for 3, 4, 5, or 8 fractions (dependent on tumor type/location; 45-70 Gy total) over approximately 2 weeks PLUS placebo (normal saline solution) via IV infusion once every 3 weeks for up to 17 cycles (up to approximately 1 year). Each cycle was 21 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.44', 'groupId': 'OG000', 'lowerLimit': '-5.23', 'upperLimit': '2.36'}, {'value': '2.91', 'groupId': 'OG001', 'lowerLimit': '-0.87', 'upperLimit': '6.68'}]}]}], 'analyses': [{'pValue': '0.0906', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.34', 'ciLowerLimit': '-9.38', 'ciUpperLimit': '0.69', 'groupDescription': 'LS Mean change and 95% CIs were based on a cLDA model with the EORTC QLQ-LC13 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by Disease Stage (Stage I versus Stage II), ECOG Performance Status (0 or 1 versus 2), Geographic Region of Enrollment Site (East Asia versus non-East Asia), and Reason For Not Receiving Surgery (medically inoperable versus refused surgery).', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and up to 24 weeks', 'description': 'The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant responses to the EORTC QLQ-LC13 question "How much did you cough?" were scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores were standardized, so that scores ranged from 0 to 100. A lower score indicates a better outcome. The change from baseline in cough (EORTC QLQ LC13 Item 31) score was reported for each arm.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study intervention and had at least 1 EORTC QLQ-LC13 assessment available were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer Module 13 (EORTC QLQ-LC13) Chest Pain (Item 40) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SBRT + Pembrolizumab', 'description': 'Participants received SBRT once every 3 days for 3, 4, 5, or 8 fractions (dependent on tumor type/location; 45-70 Gray \\[Gy\\] total) over approximately 2 weeks PLUS pembrolizumab 200 mg via IV infusion once every 3 weeks for up to 17 cycles (up to approximately 1 year). Each cycle was 21 days.'}, {'id': 'OG001', 'title': 'SBRT + Placebo', 'description': 'Participants received SBRT once every 3 days for 3, 4, 5, or 8 fractions (dependent on tumor type/location; 45-70 Gy total) over approximately 2 weeks PLUS placebo (normal saline solution) via IV infusion once every 3 weeks for up to 17 cycles (up to approximately 1 year). Each cycle was 21 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.00', 'groupId': 'OG000', 'lowerLimit': '-0.09', 'upperLimit': '6.10'}, {'value': '1.76', 'groupId': 'OG001', 'lowerLimit': '-1.32', 'upperLimit': '4.84'}]}]}], 'analyses': [{'pValue': '0.5482', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.24', 'ciLowerLimit': '-2.83', 'ciUpperLimit': '5.31', 'groupDescription': 'LS Mean change and 95% CIs were based on a cLDA model with the EORTC QLQ-LC13 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by Disease Stage (Stage I versus Stage II), ECOG Performance Status (0 or 1 versus 2), Geographic Region of Enrollment Site (East Asia versus non-East Asia), and Reason For Not Receiving Surgery (medically inoperable versus refused surgery).', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and up to 24 weeks', 'description': 'The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant responses to the question "Have you had pain in your chest?" were scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores were standardized, so that scores ranged from 0 to 100. A lower score indicates a better outcome. The change from baseline in chest pain (EORTC QLQ-LC13 Item 40) score was reported for each arm.', 'unitOfMeasure': 'Score on a Scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study intervention and had at least 1 EORTC QLQ-LC13 assessment available were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Dyspnea (Item 8) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SBRT + Pembrolizumab', 'description': 'Participants received SBRT once every 3 days for 3, 4, 5, or 8 fractions (dependent on tumor type/location; 45-70 Gray \\[Gy\\] total) over approximately 2 weeks PLUS pembrolizumab 200 mg via IV infusion once every 3 weeks for up to 17 cycles (up to approximately 1 year). Each cycle was 21 days.'}, {'id': 'OG001', 'title': 'SBRT + Placebo', 'description': 'Participants received SBRT once every 3 days for 3, 4, 5, or 8 fractions (dependent on tumor type/location; 45-70 Gy total) over approximately 2 weeks PLUS placebo (normal saline solution) via IV infusion once every 3 weeks for up to 17 cycles (up to approximately 1 year). Each cycle was 21 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.80', 'groupId': 'OG000', 'lowerLimit': '-5.95', 'upperLimit': '2.36'}, {'value': '-0.81', 'groupId': 'OG001', 'lowerLimit': '-4.94', 'upperLimit': '3.32'}]}]}], 'analyses': [{'pValue': '0.7253', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.99', 'ciLowerLimit': '-6.50', 'ciUpperLimit': '4.53', 'groupDescription': 'LS Mean change and 95% CIs were based on a cLDA model with the EORTC QLQ-C30 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by Disease Stage (Stage I versus Stage II), ECOG Performance Status (0 or 1 versus 2), Geographic Region of Enrollment Site (East Asia versus non-East Asia), and Reason For Not Receiving Surgery (medically inoperable versus refused surgery).', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and up to 24 weeks', 'description': 'The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "Were you short of breath?" were scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores were standardized, so that scores ranged from 0 to 100. A lower score indicates a better outcome. The change from baseline in dyspnea (EORTC QLQ-C30 Item 8) score was reported for each arm.', 'unitOfMeasure': 'Score on a Scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study intervention and had at least 1 EORTC QLQ-C30 assessment available were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Physical Functioning (Items 1-5) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SBRT + Pembrolizumab', 'description': 'Participants received SBRT once every 3 days for 3, 4, 5, or 8 fractions (dependent on tumor type/location; 45-70 Gray \\[Gy\\] total) over approximately 2 weeks PLUS pembrolizumab 200 mg via IV infusion once every 3 weeks for up to 17 cycles (up to approximately 1 year). Each cycle was 21 days.'}, {'id': 'OG001', 'title': 'SBRT + Placebo', 'description': 'Participants received SBRT once every 3 days for 3, 4, 5, or 8 fractions (dependent on tumor type/location; 45-70 Gy total) over approximately 2 weeks PLUS placebo (normal saline solution) via IV infusion once every 3 weeks for up to 17 cycles (up to approximately 1 year). Each cycle was 21 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.52', 'groupId': 'OG000', 'lowerLimit': '-3.08', 'upperLimit': '2.03'}, {'value': '-0.31', 'groupId': 'OG001', 'lowerLimit': '-2.86', 'upperLimit': '2.24'}]}]}], 'analyses': [{'pValue': '0.9055', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.21', 'ciLowerLimit': '-3.70', 'ciUpperLimit': '3.28', 'groupDescription': 'LS Mean change and 95% CIs were based on a cLDA model with the EORTC QLQ-C30 scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by Disease Stage (Stage I versus Stage II), ECOG Performance Status (0 or 1 versus 2), Geographic Region of Enrollment Site (East Asia versus non-East Asia), and Reason For Not Receiving Surgery (medically inoperable versus refused surgery).', 'statisticalMethod': 'cLDA model', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and up to 24 weeks', 'description': 'The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning were scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores were standardized, so that scores ranged from 0 to 100. A higher score indicates a better quality of life. The change from baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) combined score was reported for each arm.', 'unitOfMeasure': 'Score on a Scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 dose of study intervention and had at least 1 EORTC QLQ-C30 assessment available were analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SBRT + Pembrolizumab', 'description': 'Participants received SBRT once every 3 days for 3, 4, 5, or 8 fractions (dependent on tumor type/location; 45-70 Gray \\[Gy\\] total) over approximately 2 weeks PLUS pembrolizumab 200 mg via IV infusion once every 3 weeks for up to 17 cycles (up to approximately 1 year). Each cycle was 21 days.'}, {'id': 'FG001', 'title': 'SBRT + Placebo', 'description': 'Participants received SBRT once every 3 days for 3, 4, 5, or 8 fractions (dependent on tumor type/location; 45-70 Gy total) over approximately 2 weeks PLUS placebo (normal saline solution) via IV infusion once every 3 weeks for up to 17 cycles (up to approximately 1 year). Each cycle was 21 days.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '227'}, {'groupId': 'FG001', 'numSubjects': '221'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '226'}, {'groupId': 'FG001', 'numSubjects': '218'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '227'}, {'groupId': 'FG001', 'numSubjects': '221'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '73'}, {'groupId': 'FG001', 'numSubjects': '62'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Study Terminated By Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '144'}, {'groupId': 'FG001', 'numSubjects': '153'}]}]}], 'recruitmentDetails': 'Male and female participants at least 18 years of age with unresected Stage I or II (limited Stage IIB N0, M0) Non-Small Cell Lung Cancer (NSCLC) who had received no prior anticancer therapy for their present lung cancer were recruited.', 'preAssignmentDetails': 'Of 737 participants screened, 448 were randomized 1:1 to receive either stereotactic body radiotherapy (SBRT) plus pembrolizumab or SBRT plus placebo.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'BG000'}, {'value': '221', 'groupId': 'BG001'}, {'value': '448', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'SBRT + Pembrolizumab', 'description': 'Participants received SBRT once every 3 days for 3, 4, 5, or 8 fractions (dependent on tumor type/location; 45-70 Gray \\[Gy\\] total) over approximately 2 weeks PLUS pembrolizumab 200 mg via IV infusion once every 3 weeks for up to 17 cycles (up to approximately 1 year). Each cycle was 21 days.'}, {'id': 'BG001', 'title': 'SBRT + Placebo', 'description': 'Participants received SBRT once every 3 days for 3, 4, 5, or 8 fractions (dependent on tumor type/location; 45-70 Gy total) over approximately 2 weeks PLUS placebo (normal saline solution) via IV infusion once every 3 weeks for up to 17 cycles (up to approximately 1 year). Each cycle was 21 days.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '73.2', 'spread': '8.0', 'groupId': 'BG000'}, {'value': '72.4', 'spread': '7.6', 'groupId': 'BG001'}, {'value': '72.8', 'spread': '7.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '89', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '189', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '138', 'groupId': 'BG000'}, {'value': '121', 'groupId': 'BG001'}, {'value': '259', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '190', 'groupId': 'BG000'}, {'value': '186', 'groupId': 'BG001'}, {'value': '376', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '183', 'groupId': 'BG000'}, {'value': '177', 'groupId': 'BG001'}, {'value': '360', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Score', 'classes': [{'categories': [{'title': 'ECOG PS 0 = Normal activity', 'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '170', 'groupId': 'BG002'}]}, {'title': 'ECOG PS 1 = Symptoms, but ambulatory', 'measurements': [{'value': '122', 'groupId': 'BG000'}, {'value': '122', 'groupId': 'BG001'}, {'value': '244', 'groupId': 'BG002'}]}, {'title': 'ECOG PS 2 = Ambulatory, capable of selfcare, unable to carry out work activities', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "The ECOG PS Score describes a participant's level of functioning in terms of their ability to care for themself, daily activity, and physical ability, and ranges from 0 (fully active) to 5 (dead). An ECOG PS of 0 (Fully active, able to carry on all pre-disease performance without restriction), 1 (Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature), or 2 (Ambulatory and capable of all self-care, but unable to carry out any work activities) was required for inclusion in the study and used to stratify randomization.", 'unitOfMeasure': 'Participants'}, {'title': 'NSCLC Disease Stage', 'classes': [{'categories': [{'title': 'Stage I', 'measurements': [{'value': '204', 'groupId': 'BG000'}, {'value': '197', 'groupId': 'BG001'}, {'value': '401', 'groupId': 'BG002'}]}, {'title': 'Stage II', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants were categorized as NSCLC Stage I or NSCLC Stage II according to the American Joint Committee on Cancer Manual 8th Edition (AJCC V8). NSCLC stages range from I to IV, with higher stage numbers indicating that the cancer is more advanced. NSCLC Stage (I or II) was used as a randomization stratification factor.', 'unitOfMeasure': 'Participants'}, {'title': 'Geographic Region of Enrollment Site', 'classes': [{'categories': [{'title': 'East Asia', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}, {'title': 'Non-East Asia', 'measurements': [{'value': '198', 'groupId': 'BG000'}, {'value': '195', 'groupId': 'BG001'}, {'value': '393', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Geographic region of enrolment site (East Asia versus non-East Asia) was used as a randomization stratification factor.', 'unitOfMeasure': 'Participants'}, {'title': 'Reason for not Receiving Surgery', 'classes': [{'categories': [{'title': 'Refused Surgery', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}, {'title': 'Medically Inoperable', 'measurements': [{'value': '184', 'groupId': 'BG000'}, {'value': '185', 'groupId': 'BG001'}, {'value': '369', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The "Reason for not receiving surgery" (medically inoperable versus refused surgery) was used as a randomization stratification factor.', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-10-11', 'size': 1449439, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-04-25T11:47', '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': 448}}, 'statusModule': {'whyStopped': 'Terminated for business reasons', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-06-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-01-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-24', 'studyFirstSubmitDate': '2019-04-22', 'resultsFirstSubmitDate': '2025-04-25', 'studyFirstSubmitQcDate': '2019-04-22', 'lastUpdatePostDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-04-25', 'studyFirstPostDateStruct': {'date': '2019-04-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Event-free Survival (EFS)', 'timeFrame': 'Up to approximately 56.8 months', 'description': 'EFS was defined as the time from randomization to the first occurrence of any of the following events: 1) local, regional, or distant recurrence of disease as assessed by radiographic recurrence by blinded independent central review (BICR), positive pathology by local assessment, physical examination by local assessment confirmed by positive pathology and/or radiographic recurrence by BICR, OR 2) death due to any cause. EFS was reported for each arm.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to approximately 56.8 months', 'description': 'OS was defined as the time from date of randomization to date of death from any cause. OS was reported for each arm.'}, {'measure': 'Time to Death or Distant Metastases (TDDM)', 'timeFrame': 'Up to approximately 56.8 months', 'description': 'TTDM was defined as the time from randomization to the first documented distant metastases or death from any cause, whichever occurred first. The TDDM was reported for each arm.'}, {'measure': 'Number of Participants Who Experienced an Adverse Event (AE)', 'timeFrame': 'Up to approximately 64 months', 'description': 'An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experienced an AE were reported.'}, {'measure': 'Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)', 'timeFrame': 'Up to approximately 16 months', 'description': 'An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinued study treatment due to an AE were reported.'}, {'measure': 'Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Score', 'timeFrame': 'Baseline and up to 24 weeks', 'description': 'The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" were scored on a 7-point scale (1=Very Poor to 7=Excellent). The combined score of Global Health Status (EORTC QLQ-C30 Item 29) and Quality of Life (EORTC QLQ-C30 Item 30) was computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicates a better outcome. The change from baseline in GHS/QoL combined score was reported for each arm.'}, {'measure': 'Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer Module 13 (EORTC QLQ-LC13) Cough (Item 31) Score', 'timeFrame': 'Baseline and up to 24 weeks', 'description': 'The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant responses to the EORTC QLQ-LC13 question "How much did you cough?" were scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores were standardized, so that scores ranged from 0 to 100. A lower score indicates a better outcome. The change from baseline in cough (EORTC QLQ LC13 Item 31) score was reported for each arm.'}, {'measure': 'Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer Module 13 (EORTC QLQ-LC13) Chest Pain (Item 40) Score', 'timeFrame': 'Baseline and up to 24 weeks', 'description': 'The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant responses to the question "Have you had pain in your chest?" were scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores were standardized, so that scores ranged from 0 to 100. A lower score indicates a better outcome. The change from baseline in chest pain (EORTC QLQ-LC13 Item 40) score was reported for each arm.'}, {'measure': 'Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Dyspnea (Item 8) Score', 'timeFrame': 'Baseline and up to 24 weeks', 'description': 'The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the question "Were you short of breath?" were scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores were standardized, so that scores ranged from 0 to 100. A lower score indicates a better outcome. The change from baseline in dyspnea (EORTC QLQ-C30 Item 8) score was reported for each arm.'}, {'measure': 'Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Physical Functioning (Items 1-5) Score', 'timeFrame': 'Baseline and up to 24 weeks', 'description': 'The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning were scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores were standardized, so that scores ranged from 0 to 100. A higher score indicates a better quality of life. The change from baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) combined score was reported for each arm.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Programmed Cell Death-1 (PD1, PD-1)', 'Programmed Death-Ligand 1 (PDL1, PD-L1)', 'Programmed Cell Death Receptor Ligand 2 (PDL2, PD-L2)'], 'conditions': ['Non-Small Cell Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '39298144', 'type': 'DERIVED', 'citation': 'Swaminath A, Parpia S, Wierzbicki M, Kundapur V, Faria S, Okawara GS, Tsakiridis TK, Ahmed N, Bujold A, Hirmiz K, Owen T, Leong N, Ramchandar K, Filion E, Lau H, Gabos Z, Thompson R, Yaremko B, Mehiri S, Louie AV, Quan K, Levine MN, Wright JR, Whelan TJ. Stereotactic vs Hypofractionated Radiotherapy for Inoperable Stage I Non-Small Cell Lung Cancer: The LUSTRE Phase 3 Randomized Clinical Trial. JAMA Oncol. 2024 Nov;10(11):1571-1575. doi: 10.1001/jamaoncol.2024.3089. Epub 2024 Sep 19.'}], 'seeAlsoLinks': [{'url': 'https://www.merckclinicaltrials.com/', 'label': 'Merck Clinical Trials Information'}, {'url': 'https://msd.trialsummaries.com/Study/StudyDetails?id=26213&tenant=MT_MSD_9011', 'label': 'Plain Language Summary'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the efficacy and safety of stereotactic body radiotherapy (SBRT) plus pembrolizumab (MK-3475) in the treatment of adult participants with unresected Stage I or II (Stage IIB N0, M0) non-small cell lung cancer (NSCLC).\n\nThe primary study hypothesis is SBRT plus pembrolizumab prolongs Event-free Survival (EFS) compared to SBRT plus placebo (normal saline solution).', 'detailedDescription': 'As of protocol amendment 8, the study was stopped due to an interim analysis that did not support the study primary and key secondary endpoints. All study participants stopped ongoing treatment with pembrolizumab/placebo, and must complete end of trial and safety follow-up visits.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Has previously untreated non-small cell lung cancer (NSCLC) diagnosed by histology or cytology and confirmed as Stage I or II (T1 to limited T3, N0, M0) NSCLC (American Joint Committee on Cancer, AJCC) by chest computed tomography (CT) and positron emission tomography (PET) scan. Participants with pericardium invasion, \\>2 nodules or 2 nodules that cannot be treated in one field (\\>2 cm apart and/or total planned target volume \\[PTV\\] \\>163 cc) and diaphragm elevation suggestive of phrenic nerve invasion are excluded\n* Cannot undergo thoracic surgery due to existing medical illness(es) as determined by the site's multi-disciplinary tumor board. Medically operable participants who decide to treat with stereotactic body radiotherapy (SBRT) as definitive therapy rather than surgery are also eligible, if patient's unwillingness to undergo surgical resection is clearly documented\n* Has a Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2\n* Is able to receive SBRT and does not have an ultra-centrally located tumor\n* Has adequate organ function within 7 days prior to the start of study treatment\n* A female is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: a) not a women of childbearing potential (WOCBP) OR b) A WOCBP and uses contraceptive method that is highly effective (with a failure rate of \\<1% per year), or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), during the intervention period and for at least 120 days after the last dose of pembrolizumab/placebo and 180 days after the last radiotherapy dose\n* Male participants are eligible to participate if they agree to the following during the intervention period and for at least 90 days after the last dose of radiotherapy: refrain from donating sperm plus either be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent or must agree to use contraception per study protocol, unless confirmed to be azoospermic\n* Has a radiation therapy plan approved by the central radiation therapy quality assurance vendor\n\nExclusion Criteria:\n\n* Has received prior therapy with an anti-programmed cell death-1 (anti-PD-1), anti-programmed cell death-ligand 1 (anti-PD-L1), or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated antigen 4 \\[CTLA-4\\], tumor necrosis factor receptor superfamily member 4 \\[OX-40\\], tumor necrosis factor receptor superfamily member 9 \\[CD137\\])\n* Has received prior radiotherapy to the thorax, including radiotherapy to the esophagus, mediastinum, or breast\n* Has received a live vaccine within 30 days prior to the first dose of study intervention\n* Has received an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention administration\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study treatment\n* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. A prior NSCLC that occurred and was treated curatively at least 2 years prior to the date of the current diagnosis would be considered a separate primary lung cancer, and therefore an additional malignancy. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast c carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.\n* Has a known hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients\n* Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis\n* Has a known history of Hepatitis B or known active Hepatitis C virus infection\n* Has an active autoimmune disease that has required systemic treatment in past 2 years, except replacement therapy\n* Has an active infection requiring systemic therapy\n* Has a known history of human immunodeficiency virus (HIV) infection\n* Has a known history of active tuberculosis (TB; Bacillus tuberculosis)\n* Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of pembrolizumab/placebo and 180 days after the last radiotherapy dose\n* Have not adequately recovered from major surgery or have ongoing surgical complications\n* Has had an allogenic tissue/solid organ transplant"}, 'identificationModule': {'nctId': 'NCT03924869', 'briefTitle': 'Efficacy and Safety Study of Stereotactic Body Radiotherapy (SBRT) With or Without Pembrolizumab (MK-3475) in Adults With Unresected Stage I or II Non-Small Cell Lung Cancer (NSCLC) (MK-3475-867/KEYNOTE-867)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Phase 3, Randomized, Placebo-Controlled Clinical Study to Evaluate the Safety and Efficacy of Stereotactic Body Radiotherapy (SBRT) With or Without Pembrolizumab (MK-3475) in Participants With Unresected Stages I or II Non Small Cell Lung Cancer (NSCLC) (KEYNOTE-867)', 'orgStudyIdInfo': {'id': '3475-867'}, 'secondaryIdInfos': [{'id': 'MK-3475-867', 'type': 'OTHER', 'domain': 'MSD'}, {'id': 'KEYNOTE-867', 'type': 'OTHER', 'domain': 'MSD'}, {'id': '194909', 'type': 'REGISTRY', 'domain': 'JAPAC-CTI'}, {'id': '2022-500413-11-00', 'type': 'REGISTRY', 'domain': 'EU CT'}, {'id': 'U1111-1275-8515', 'type': 'REGISTRY', 'domain': 'UTN'}, {'id': '2018-004320-11', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SBRT + Pembrolizumab', 'description': 'Participants receive SBRT once every 3 days for 3, 4, 5, or 8 fractions (dependent on tumor type/location; 45-70 Gray \\[Gy\\] total) over approximately 2 weeks PLUS pembrolizumab 200 mg via intravenous (IV) infusion once every 3 weeks for up to 17 cycles (up to approximately 1 year). Each cycle is 21 days.', 'interventionNames': ['Radiation: Stereotactic Body Radiotherapy (SBRT)', 'Biological: Pembrolizumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'SBRT + Placebo', 'description': 'Participants receive SBRT once every 3 days for 3, 4, 5, or 8 fractions (dependent on tumor type/location; 45-70 Gy total) over approximately 2 weeks PLUS placebo (normal saline solution) via IV infusion once every 3 weeks for up to 17 cycles (up to approximately 1 year). Each cycle is 21 days.', 'interventionNames': ['Radiation: Stereotactic Body Radiotherapy (SBRT)', 'Drug: Placebo']}], 'interventions': [{'name': 'Stereotactic Body Radiotherapy (SBRT)', 'type': 'RADIATION', 'description': 'SBRT will be administered once every 3 days for 3, 4, 5, or 8 fractions (dependent on tumor type/location; 45-70 Gray \\[Gy\\] total) over approximately 2 weeks.', 'armGroupLabels': ['SBRT + Pembrolizumab', 'SBRT + Placebo']}, {'name': 'Pembrolizumab', 'type': 'BIOLOGICAL', 'otherNames': ['MK-3475', 'KEYTRUDA®'], 'description': 'Pembrolizumab will be administered at 200 mg via IV infusion once every 3 weeks for up to 17 cycles (up to approximately 1 year).', 'armGroupLabels': ['SBRT + Pembrolizumab']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo (normal saline solution) will be administered at 200 mg via IV infusion once every 3 weeks for up to 17 cycles (up to approximately 1 year).', 'armGroupLabels': ['SBRT + Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama ( Site 0099)', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '36607', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Infirmary Cancer Care ( Site 3044)', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '99508', 'city': 'Anchorage', 'state': 'Alaska', 'country': 'United States', 'facility': 'Alaska Oncology and Hematology ( Site 3063)', 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}, {'zip': '85234', 'city': 'Gilbert', 'state': 'Arizona', 'country': 'United States', 'facility': 'Banner MD Anderson Cancer Center ( Site 3029)', 'geoPoint': {'lat': 33.35283, 'lon': -111.78903}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'CARTI Cancer Center ( Site 3045)', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'USC Norris Comprehensive Cancer Center ( Site 0007)', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Veterans Affairs Palo Alto Health Care System ( Site 3039)', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '80206', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'National Jewish Health ( Site 0010)', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University ( Site 0011)', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '32763', 'city': 'Orange City', 'state': 'Florida', 'country': 'United States', 'facility': 'Mid Florida Hematology and Oncology Center ( Site 0067)', 'geoPoint': {'lat': 28.94888, 'lon': -81.29867}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'H. 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