Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-25 @ 8:16 PM
Study NCT ID:
NCT03443869
Status:
COMPLETED
Last Update Posted:
2023-07-28
First Post:
2018-02-19
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Letermovir Versus Valganciclovir to Prevent Human Cytomegalovirus Disease in Kidney Transplant Recipients (MK-8228-002)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000588473', 'term': 'letermovir'}, {'id': 'D000077562', 'term': 'Valganciclovir'}, {'id': 'D000212', 'term': 'Acyclovir'}], 'ancestors': [{'id': 'D015774', 'term': 'Ganciclovir'}, {'id': 'D006147', 'term': 'Guanine'}, {'id': 'D007042', 'term': 'Hypoxanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, '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': 'If publication activity was not directed by the sponsor, the investigator agreed to submit all manuscripts or abstracts to the sponsor before submission. This allowed the sponsor to protect proprietary information and to provide comments.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 52 weeks', 'description': 'All-Cause Mortality included all randomized participants. Non-serious and SAEs were reported for all randomized participants who received at least one dose of study treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Letermovir', 'description': 'LET 480 mg (or 240 mg when administered concomitantly with cyclosporin A) tablet orally; placebo to VGCV tablet orally once daily; and 400-mg capsule of ACV orally every 12 hours for 28 weeks', 'otherNumAtRisk': 292, 'deathsNumAtRisk': 301, 'otherNumAffected': 239, 'seriousNumAtRisk': 292, 'deathsNumAffected': 5, 'seriousNumAffected': 118}, {'id': 'EG001', 'title': 'Valganciclovir', 'description': '900 mg VGCV tablet orally, once daily; placebo to LET tablet orally once daily; and placebo to ACV orally every 12 hours for 28 weeks', 'otherNumAtRisk': 297, 'deathsNumAtRisk': 300, 'otherNumAffected': 243, 'seriousNumAtRisk': 297, 'deathsNumAffected': 3, 'seriousNumAffected': 129}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 25, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 36, 'numAffected': 34}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 46, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 125, 'numAffected': 105}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 60, 'numAffected': 50}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 22, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 28, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 36, 'numAffected': 31}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 130, 'numAffected': 99}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 101, 'numAffected': 85}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 20, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 17, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 40, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 48, 'numAffected': 37}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 31, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 32, 'numAffected': 26}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 21, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 38, 'numAffected': 34}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 52, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 61, 'numAffected': 47}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 24, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 29, 'numAffected': 24}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Cytomegalovirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Polyomavirus viraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 18, 'numAffected': 16}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 51, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 60, 'numAffected': 45}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 29, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 46, 'numAffected': 39}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 20, 'numAffected': 15}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 22, 'numAffected': 21}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 36, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 44, 'numAffected': 38}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 22, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 44, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 47, 'numAffected': 40}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 38, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 41, 'numAffected': 36}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 19, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 18, 'numAffected': 17}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 19, 'numAffected': 17}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 17, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 14, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 27, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 27, 'numAffected': 21}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 56, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 52, 'numAffected': 52}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 16, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 17, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 16, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 26, 'numAffected': 23}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 23, 'numAffected': 22}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 43, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 46, 'numAffected': 43}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 21, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 14, 'numAffected': 13}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 22, 'numAffected': 19}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Metabolic acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 17, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 15, 'numAffected': 14}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Hypoplastic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Sickle cell anaemia with crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Cardiogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Abdominal wall haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Faecaloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 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'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Device dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Hallucination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Acute kidney 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'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Renal artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Renal cyst haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Ureteric stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Urethral stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Urinary incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Urinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Acute pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Dyspnoea', 'stats': 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[{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Extremity necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Hypertensive emergency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Iliac artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Lymphocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Peripheral artery thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Glomerulonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Renal tubular necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 292, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 297, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Adjudicated Cytomegalovirus (CMV) Disease Through 52 Weeks Post-transplant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'OG000'}, {'value': '297', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Letermovir', 'description': 'Letermovir (LET) 480 mg (or 240 mg when administered concomitantly with cyclosporin A) tablet orally; placebo to valganciclovir (VGCV) tablet orally once daily; and 400-mg capsule of acyclovir (ACV) orally every 12 hours for 28 weeks'}, {'id': 'OG001', 'title': 'Valganciclovir', 'description': '900 mg VGCV tablet orally, once daily; placebo to LET tablet orally once daily; and placebo to ACV orally every 12 hours for 28 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '10.4', 'groupId': 'OG000'}, {'value': '11.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Stratum-adjusted Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.4', 'ciLowerLimit': '-6.5', 'ciUpperLimit': '3.8', 'estimateComment': 'Difference = LET minus VGCV', 'groupDescription': 'The Observed failure (OF) approach was used to handle missing values, that is participants who had discontinued prematurely from the study for any reason were not considered failures', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'LET was concluded non-inferior to VGCV if the upper bound of the two-sided 95% CI for difference in percentage of participants with adjudicated CMV disease (LET - VGCV) was no higher than 10%'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 52 weeks', 'description': 'CMV disease was defined as the presence of either CMV end-organ disease or CMV syndrome and was confirmed by an independent, blinded Clinical Adjudication Committee (CAC). Only CAC-confirmed ("adjudicated") cases were included in percentage of participants who met the endpoint. Investigator-assessed cases which were not confirmed by the CAC were not included.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study treatment, were CMV seropositive organ donor/CMV seronegative organ recipient (D+/R-), and had no detectable CMV viral DNA (measured by central laboratory) on Day 1.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Adjudicated CMV Disease Through 28 Weeks Post-transplant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'OG000'}, {'value': '297', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Letermovir', 'description': 'Letermovir (LET) 480 mg (or 240 mg when administered concomitantly with cyclosporin A) tablet orally; placebo to valganciclovir (VGCV) tablet orally once daily; and 400-mg capsule of acyclovir (ACV) orally every 12 hours for 28 weeks'}, {'id': 'OG001', 'title': 'Valganciclovir', 'description': '900 mg VGCV tablet orally, once daily; placebo to LET tablet orally once daily; and placebo to ACV orally every 12 hours for 28 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Stratum-adjusted Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.7', 'ciLowerLimit': '-3.4', 'ciUpperLimit': '0.1', 'estimateComment': 'Difference = LET minus VGCV', 'groupDescription': 'The Observed failure (OF) approach was used to handle missing values, that is participants who had discontinued prematurely from the study for any reason were not considered failures', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 28 weeks', 'description': 'CMV disease was defined as the presence of either CMV end-organ disease or CMV syndrome and was confirmed by an independent, blinded CAC. Only CAC-confirmed ("adjudicated") cases were included in percentage of participants who met the endpoint. Investigator-assessed cases which were not confirmed by the CAC were not included.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study treatment, were D+/R-, and had no detectable CMV viral DNA (measured by central laboratory) on Day 1.'}, {'type': 'SECONDARY', 'title': 'Time to Onset of Adjudicated CMV Disease Through 52 Weeks Post-transplant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'OG000'}, {'value': '297', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Letermovir', 'description': 'Letermovir (LET) 480 mg (or 240 mg when administered concomitantly with cyclosporin A) tablet orally; placebo to valganciclovir (VGCV) tablet orally once daily; and 400-mg capsule of acyclovir (ACV) orally every 12 hours for 28 weeks'}, {'id': 'OG001', 'title': 'Valganciclovir', 'description': '900 mg VGCV tablet orally, once daily; placebo to LET tablet orally once daily; and placebo to ACV orally every 12 hours for 28 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'NA=The median time to event was not reached as fewer than half the participants reached this endpoint.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'NA=The median time to event was not reached as fewer than half the participants reached this endpoint.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 52 weeks', 'description': 'The time to onset of adjudicated CMV disease was calculated in days, from the day of randomization to the day of onset of CMV disease as determined by the CAC.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study treatment, were D+/R-, and had no detectable CMV viral DNA (measured by central laboratory) on Day 1.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Any AE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}, {'value': '297', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Letermovir', 'description': 'Letermovir (LET) 480 mg (or 240 mg when administered concomitantly with cyclosporin A) tablet orally; placebo to valganciclovir (VGCV) tablet orally once daily; and 400-mg capsule of acyclovir (ACV) orally every 12 hours for 28 weeks'}, {'id': 'OG001', 'title': 'Valganciclovir', 'description': '900 mg VGCV tablet orally, once daily; placebo to LET tablet orally once daily; and placebo to ACV orally every 12 hours for 28 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '92.8', 'groupId': 'OG000'}, {'value': '92.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-4.4', 'ciUpperLimit': '4.2', 'estimateComment': 'Difference = LET minus VGCV', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 52 weeks', 'description': "An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, was also an AE.", 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Any Drug-related Serious Adverse Event (SAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '292', 'groupId': 'OG000'}, {'value': '297', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Letermovir', 'description': 'Letermovir (LET) 480 mg (or 240 mg when administered concomitantly with cyclosporin A) tablet orally; placebo to valganciclovir (VGCV) tablet orally once daily; and 400-mg capsule of acyclovir (ACV) orally every 12 hours for 28 weeks'}, {'id': 'OG001', 'title': 'Valganciclovir', 'description': '900 mg VGCV tablet orally, once daily; placebo to LET tablet orally once daily; and placebo to ACV orally every 12 hours for 28 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000'}, {'value': '5.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.7', 'ciLowerLimit': '-7.0', 'ciUpperLimit': '-0.9', 'estimateComment': 'Difference = LET minus VGCV', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 52 weeks', 'description': 'An SAE was an AE that resulted in death, was life threatening, resulted in persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a cancer, was associated with an overdose, was another important medical event. SAEs that the investigator determined the relationship of the AE to the treatment as at least possibly related were reported.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least one dose of study treatment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Letermovir', 'description': 'Letermovir (LET) 480 mg (or 240 mg when administered concomitantly with cyclosporin A) tablet orally; placebo to valganciclovir (VGCV) tablet orally once daily; and 400-mg capsule of acyclovir (ACV) orally every 12 hours for 28 weeks'}, {'id': 'FG001', 'title': 'Valganciclovir', 'description': '900 mg VGCV tablet orally, once daily; placebo to LET tablet orally once daily; and placebo to ACV orally every 12 hours for 28 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '301'}, {'groupId': 'FG001', 'numSubjects': '300'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '292'}, {'groupId': 'FG001', 'numSubjects': '297'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '256'}, {'groupId': 'FG001', 'numSubjects': '266'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '34'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'Male/Female participants of at least 18 years of age with receipt of a kidney transplant were enrolled in this trial.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'BG000'}, {'value': '300', 'groupId': 'BG001'}, {'value': '601', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Letermovir', 'description': 'Letermovir (LET) 480 mg (or 240 mg when administered concomitantly with cyclosporin A) tablet orally; placebo to valganciclovir (VGCV) tablet orally once daily; and 400-mg capsule of acyclovir (ACV) orally every 12 hours for 28 weeks'}, {'id': 'BG001', 'title': 'Valganciclovir', 'description': '900 mg VGCV tablet orally, once daily; placebo to LET tablet orally once daily; and placebo to ACV orally every 12 hours for 28 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.6', 'spread': '14.8', 'groupId': 'BG000'}, {'value': '49.5', 'spread': '15.1', 'groupId': 'BG001'}, {'value': '49.6', 'spread': '14.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '174', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '217', 'groupId': 'BG000'}, {'value': '210', 'groupId': 'BG001'}, {'value': '427', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '230', 'groupId': 'BG000'}, {'value': '240', 'groupId': 'BG001'}, {'value': '470', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '15', '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': '22', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '259', 'groupId': 'BG000'}, {'value': '246', 'groupId': 'BG001'}, {'value': '505', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-08-27', 'size': 1496098, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-03-23T09:06', 'hasProtocol': True}, {'date': '2022-06-15', 'size': 316413, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-03-23T09:06', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 601}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2022-04-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-26', 'studyFirstSubmitDate': '2018-02-19', 'resultsFirstSubmitDate': '2023-03-23', 'studyFirstSubmitQcDate': '2018-02-19', 'lastUpdatePostDateStruct': {'date': '2023-07-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-03-23', 'studyFirstPostDateStruct': {'date': '2018-02-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-04-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Adjudicated Cytomegalovirus (CMV) Disease Through 52 Weeks Post-transplant', 'timeFrame': 'Up to 52 weeks', 'description': 'CMV disease was defined as the presence of either CMV end-organ disease or CMV syndrome and was confirmed by an independent, blinded Clinical Adjudication Committee (CAC). Only CAC-confirmed ("adjudicated") cases were included in percentage of participants who met the endpoint. Investigator-assessed cases which were not confirmed by the CAC were not included.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Adjudicated CMV Disease Through 28 Weeks Post-transplant', 'timeFrame': 'Up to 28 weeks', 'description': 'CMV disease was defined as the presence of either CMV end-organ disease or CMV syndrome and was confirmed by an independent, blinded CAC. Only CAC-confirmed ("adjudicated") cases were included in percentage of participants who met the endpoint. Investigator-assessed cases which were not confirmed by the CAC were not included.'}, {'measure': 'Time to Onset of Adjudicated CMV Disease Through 52 Weeks Post-transplant', 'timeFrame': 'Up to 52 weeks', 'description': 'The time to onset of adjudicated CMV disease was calculated in days, from the day of randomization to the day of onset of CMV disease as determined by the CAC.'}, {'measure': 'Percentage of Participants With Any AE', 'timeFrame': 'Up to 52 weeks', 'description': "An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, was also an AE."}, {'measure': 'Percentage of Participants With Any Drug-related Serious Adverse Event (SAE)', 'timeFrame': 'Up to 52 weeks', 'description': 'An SAE was an AE that resulted in death, was life threatening, resulted in persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a cancer, was associated with an overdose, was another important medical event. SAEs that the investigator determined the relationship of the AE to the treatment as at least possibly related were reported.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['CMV Disease']}, 'referencesModule': {'references': [{'pmid': '37279999', 'type': 'RESULT', 'citation': 'Limaye AP, Budde K, Humar A, Vincenti F, Kuypers DRJ, Carroll RP, Stauffer N, Murata Y, Strizki JM, Teal VL, Gilbert CL, Haber BA. Letermovir vs Valganciclovir for Prophylaxis of Cytomegalovirus in High-Risk Kidney Transplant Recipients: A Randomized Clinical Trial. JAMA. 2023 Jul 3;330(1):33-42. doi: 10.1001/jama.2023.9106.'}, {'pmid': '38853607', 'type': 'DERIVED', 'citation': 'Strizki JM, Diamond TL, Teal VL, Gilbert CL, Wang W, Stauffer N, Haber BA. Cytomegalovirus Antiviral Resistance Among Kidney Transplant Recipients in a Phase 3 Trial of Letermovir vs Valganciclovir Prophylaxis. J Infect Dis. 2024 Dec 16;230(6):e1287-e1298. doi: 10.1093/infdis/jiae287.'}, {'pmid': '38700045', 'type': 'DERIVED', 'citation': 'Vernooij RW, Michael M, Ladhani M, Webster AC, Strippoli GF, Craig JC, Hodson EM. Antiviral medications for preventing cytomegalovirus disease in solid organ transplant recipients. Cochrane Database Syst Rev. 2024 May 3;5(5):CD003774. doi: 10.1002/14651858.CD003774.pub5.'}], 'seeAlsoLinks': [{'url': 'https://merckclinicaltrials.com', 'label': 'Merck Clinical Trial Information'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to evaluate the efficacy of letermovir (LET) versus valganciclovir (VGCV) in preventing CMV disease in adult kidney transplant recipients. The primary hypotheses are that LET is non-inferior to VGCV; and if non-inferiority is demonstrated, that LET is superior to VGCV, in preventing CMV disease through 52 weeks post-transplant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have a documented negative serostatus for CMV within 180 days prior to randomization.\n* Anticipate receiving a primary or secondary allograft kidney from a CMV IgG seropositive (D+) donor at the time of screening AND have received a primary or secondary allograft kidney from a documented D+ donor at the time of randomization.\n* Be within 0 (i.e. day of transplantation) to 7 days (inclusive) post-kidney transplant at the time of randomization.\n* Males agree to use contraception during the treatment period, and for at least 90 days after the last dose of study treatment, and refrain from donating sperm during this period.\n* Female is not pregnant, not breastfeeding, and is not a woman of childbearing potential (WOCBP), OR if a WOCBP, agrees to follow the contraception guidance during the treatment period and for at least 90 days after the last dose of study treatment.\n\nExclusion Criteria:\n\n* Has received a previous solid organ transplant or hematopoietic stem cell transplant (HSCT). Note: Participants who have received a prior primary allograft kidney may be enrolled, provided that all other inclusion/exclusion criteria are met.\n* Is a multi-organ transplant recipient (e.g. kidney-pancreas). Double kidney transplant recipients (i.e. transplant of two kidneys from the same donor to the same recipient simultaneously) will be excluded.\n* Has a history of CMV disease or suspected CMV disease within 6 months prior to randomization.\n* Has suspected or known hypersensitivity to active or inactive ingredients of LET formulations, VGCV, GCV, and/or ACV formulations.\n* Is on dialysis or plasmapheresis at the time of randomization. Dialysis includes hemofiltration.\n* Has Child-Pugh Class C severe hepatic insufficiency at screening.\n* Has both moderate hepatic insufficiency AND moderate-to-severe renal insufficiency at screening.\n* Has any uncontrolled infection on the day of randomization.\n* Has documented positive results for human immunodeficiency virus antibody (HIV-Ab) test at any time prior to randomization, or for hepatitis C virus antibody (HCV-Ab) and with detectable HCV ribonucleic acid (RNA) within 90 days prior to randomization, or hepatitis B surface antigen (HBsAg) within 90 days prior to randomization.\n* Requires mechanical ventilation, or is hemodynamically unstable, at the time of randomization.\n* Has a history of malignancy ≤5 years prior to signing informed consent.\n* Is pregnant or expecting to conceive, is breastfeeding, or plans to breastfeed from the time of consent through at least 90 days following cessation of study therapy.\n* Is expecting to donate eggs or sperm starting from the time of consent through at least 90 days following cessation of study therapy.\n* Has received within 30 days prior to randomization or plans to receive during the study any of the following anti-CMV IgG antibody treatment or anti-CMV drug therapy including the following: Cidofovir, CMV hyper-immune globulin, Any investigational CMV antiviral agent/biologic therapy.\n* Has received within 7 days prior to randomization or plans to receive during the study any of the following anti-CMV drug therapy: LET, GCV, VGCV, Foscarnet, ACV, Valacyclovir, Famciclovir.\n* Is a user of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence.\n* Is currently participating or has participated in a study with an unapproved investigational compound or device within 28 days, or 5× half-life of the investigational compound whichever is longer, of initial dosing on this study.\n* Has previously participated in this study or any other study involving LET.\n* Has previously participated or is currently participating in any study involving administration of a CMV vaccine or another CMV investigational agent, or is planning to participate in a study of a CMV vaccine or another CMV investigational agent during the course of this study.'}, 'identificationModule': {'nctId': 'NCT03443869', 'briefTitle': 'Letermovir Versus Valganciclovir to Prevent Human Cytomegalovirus Disease in Kidney Transplant Recipients (MK-8228-002)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Phase III, Randomized, Double-Blind, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of MK-8228 (Letermovir) Versus Valganciclovir for the Prevention of Human Cytomegalovirus (CMV) Disease in Adult Kidney Transplant Recipients', 'orgStudyIdInfo': {'id': '8228-002'}, 'secondaryIdInfos': [{'id': 'MK-8228-002', 'type': 'OTHER', 'domain': 'Merck'}, {'id': '2017-001055-30', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Letermovir', 'description': 'LET 480mg (or 240 mg when administered concomitantly with cyclosporin A) tablet orally; placebo to VGCV tablet orally once daily; and 400 mg capsule of acyclovir (ACV) orally every 12 hours for 28 weeks', 'interventionNames': ['Drug: Letermovir', 'Drug: Acyclovir (ACV)', 'Drug: Placebo to VGCV']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Valganciclovir', 'description': '900 mg VGCV tablet orally, once daily; placebo to LET tablet orally once daily; and placebo to ACV orally every 12 hours for 28 weeks', 'interventionNames': ['Drug: Valganciclovir', 'Drug: Placebo to ACV', 'Drug: Placebo to LET']}], 'interventions': [{'name': 'Letermovir', 'type': 'DRUG', 'description': 'LET 480mg (or 240 mg when administered concomitantly with cyclosporin A) once daily for 28 weeks', 'armGroupLabels': ['Letermovir']}, {'name': 'Valganciclovir', 'type': 'DRUG', 'description': '900 mg VGCV tablet orally, once daily for 28 weeks', 'armGroupLabels': ['Valganciclovir']}, {'name': 'Acyclovir (ACV)', 'type': 'DRUG', 'description': '400 mg over-encapsulated ACV tablet orally, every 12 hours for 28 weeks', 'armGroupLabels': ['Letermovir']}, {'name': 'Placebo to ACV', 'type': 'DRUG', 'description': 'Over-encapsulated placebo tablet orally, every 12 hours for 28 weeks', 'armGroupLabels': ['Valganciclovir']}, {'name': 'Placebo to LET', 'type': 'DRUG', 'description': 'Placebo to LET tablet orally, once daily for 28 weeks', 'armGroupLabels': ['Valganciclovir']}, {'name': 'Placebo to VGCV', 'type': 'DRUG', 'description': 'Placebo to VGCV tablet orally, once daily for 28 weeks', 'armGroupLabels': ['Letermovir']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'UAB ( Site 0269)', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 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