Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2026-02-25 @ 8:11 PM
Study NCT ID:
NCT02927067
Status:
COMPLETED
Last Update Posted:
2023-03-03
First Post:
2016-09-29
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Maribavir Compared to Valganciclovir to Treat Cytomegalovirus Infections in People Who Have Received Stem Cell Transplants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-01-13', 'type': 'ACTUAL'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'C400401', 'term': 'maribavir'}, {'id': 'D000077562', 'term': 'Valganciclovir'}], 'ancestors': [{'id': 'D015774', 'term': 'Ganciclovir'}, {'id': 'D000212', 'term': 'Acyclovir'}, {'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': 'TrialDisclosures@takeda.com', 'phone': '+1-877-825-3327', 'title': 'Study Director', 'organization': 'Takeda'}, 'certainAgreement': {'otherDetails': 'The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All-cause mortality: From start of study drug up to end of the study (up to Week 20); Serious and Other Adverse Events: From the start of the study drug to 7 days after the last dose of study treatment (up to approximately Week 9)', 'description': 'At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Valganciclovir 900 mg BID', 'description': 'Participants received 900 mg of valganciclovir along with a placebo matched to maribavir, BID orally for 8 weeks. Valganciclovir dose was allowed to be adjusted to 450 mg BID or 450 mg QD based on renal function impairment assessed at baseline or development of neutropenia during the study.', 'otherNumAtRisk': 274, 'deathsNumAtRisk': 277, 'otherNumAffected': 256, 'seriousNumAtRisk': 274, 'deathsNumAffected': 29, 'seriousNumAffected': 95}, {'id': 'EG001', 'title': 'Maribavir 400 mg BID', 'description': 'Participants received 400 mg of maribavir along with a placebo matched to valganciclovir, BID orally for 8 weeks.', 'otherNumAtRisk': 273, 'deathsNumAtRisk': 276, 'otherNumAffected': 245, 'seriousNumAtRisk': 273, 'deathsNumAffected': 37, 'seriousNumAffected': 88}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Acute graft versus host disease in skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 46}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 62}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 18}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 20}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 18}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 50}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 47}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 30}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 14}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 23}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 64}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 74}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 144}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 44}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 13}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 27}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 17}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 10}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 24}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 24}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Taste disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 23}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 62}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 31}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 55}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'seriousEvents': [{'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Acute graft versus host disease in intestine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 10}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Acute graft versus host disease in skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 4}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Acute graft versus host disease oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Acute lymphocytic leukaemia recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Acute myeloid leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Acute myeloid leukaemia recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Acute polyneuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Acute respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Adrenal insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Adverse drug reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Autoimmune haemolytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Autonomic nervous system imbalance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'B precursor type acute leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Bone marrow failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Central nervous system lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Chronic graft versus host disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Chronic graft versus host disease in eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Chronic graft versus host disease in intestine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cystitis haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cystitis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cytomegalovirus colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cytomegalovirus enterocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cytomegalovirus gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cytomegalovirus gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cytomegalovirus gastrointestinal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cytomegalovirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cytomegalovirus infection reactivation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cytomegalovirus oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cytomegalovirus viraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Device related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Device related sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 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'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Rhinovirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Streptococcal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Subdural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Subdural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Thrombophlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Thrombotic microangiopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Toxicity to various agents', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Toxoplasmosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Transformation to acute myeloid leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Transplant rejection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Upper gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Varicella zoster virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Vascular device infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Vulvovaginal pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Warm type haemolytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 274, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 273, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Who Achieved Confirmed Clearance of Plasma Cytomegalovirus (CMV) Deoxyribose Nucleic Acid (DNA) at the End of Study Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '273', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Valganciclovir 900 mg BID', 'description': 'Participants received 900 mg of valganciclovir along with a placebo matched to maribavir, BID orally for 8 weeks. Valganciclovir dose was allowed to be adjusted to 450 mg BID or 450 mg QD based on renal function impairment assessed at baseline or development of neutropenia during the study.'}, {'id': 'OG001', 'title': 'Maribavir 400 mg BID', 'description': 'Participants received 400 mg of maribavir along with a placebo matched to valganciclovir, BID orally for 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '212', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage of Responders', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.7', 'ciLowerLimit': '-14.98', 'ciUpperLimit': '-0.36', 'estimateComment': 'Cochran-Mantel-Haenszel (CMH) weighted average approach (stratified for baseline plasma CMV DNA concentration and acute GVHD status) was used for adjusted difference in percentage of responders (Maribavir-Valganciclovir), 95% CI, and p-value.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority (NI) margin of primary efficacy endpoint was 7%. If lower limit of 95% confidence interval (CI) was greater than -7%, NI was assumed. Power calculation: Assuming 68% (maribavir), 60% (valganciclovir) participants achieve confirmed viremia clearance,494 participants (247 per group) would yield \\>90% power to declare NI based on 2-group test of equivalence in proportions. Considering 10% dropout,550 participants (275 per group) were planned to be enrolled and randomized.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 8', 'description': 'Confirmed CMV viremia clearance is defined as plasma CMV DNA concentrations less than lower limit of quantification (LLOQ; i.e. \\<137 International units per milliliter \\[IU/mL\\]), when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV Test in 2 consecutive post baseline samples separated by at least 5 days. To be considered a responder for the primary endpoint, the participant must have received exclusively study-assigned treatment (regardless of whether study-assigned treatment was completed).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified randomized set (i.e., the full analysis set) included all participants in the randomized set who took at least 1 dose of assigned study treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Achieved Confirmed CMV Viremia Clearance and CMV Infection Symptom Control at the End of Week 8, Followed by Maintenance of Treatment Effect at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '273', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Valganciclovir 900 mg BID', 'description': 'Participants received 900 mg of valganciclovir along with a placebo matched to maribavir, BID orally for 8 weeks. Valganciclovir dose was allowed to be adjusted to 450 mg BID or 450 mg QD based on renal function impairment assessed at baseline or development of neutropenia during the study.'}, {'id': 'OG001', 'title': 'Maribavir 400 mg BID', 'description': 'Participants received 400 mg of maribavir along with a placebo matched to valganciclovir, BID orally for 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '133', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage of Responders', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.4', 'ciLowerLimit': '-3.91', 'ciUpperLimit': '12.76', 'estimateComment': 'CMH weighted average approach (stratified for baseline plasma CMV DNA concentration and acute GVHD status) was used for the adjusted difference in percentage of responders (Maribavir-Valganciclovir), the corresponding 95% CI, and the p-value.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The non-inferiority margin of the key secondary efficacy endpoint was 7%. If the lower limit of the 95% CI was greater than -7%, then noninferiority (NI) was assumed. Because the NI of the primary efficacy endpoint was not established, the NI hypothesis of the key secondary endpoint was not tested formally.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 8 up to Week 16', 'description': 'Confirmed CMV viremia clearance is defined as plasma CMV DNA concentrations less than lower limit of quantification (LLOQ; i.e. \\<137 International units per milliliter \\[IU/mL\\]), when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV Test in 2 consecutive post baseline samples separated by at least 5 days. To be considered a responder for this key secondary endpoint, the participant must have received exclusively study-assigned treatment (regardless of whether study-assigned treatment was completed). CMV Infection Symptom Control is defined as no new clinical findings of CMV tissue invasive disease. Maintenance of Treatment Effect is defined as maintaining confirmed CMV viremia clearance and CMV infection symptom control through Week 16.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified randomized set (i.e., the full analysis set) included all participants in the randomized set who took at least 1 dose of assigned study treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Achieved Confirmed Clearance of Plasma CMV DNA (CMV Viremia Clearance) at Week 8 After Receiving 8 Weeks of Study Assigned Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '273', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Valganciclovir 900 mg BID', 'description': 'Participants received 900 mg of valganciclovir along with a placebo matched to maribavir, BID orally for 8 weeks. Valganciclovir dose was allowed to be adjusted to 450 mg BID or 450 mg QD based on renal function impairment assessed at baseline or development of neutropenia during the study.'}, {'id': 'OG001', 'title': 'Maribavir 400 mg BID', 'description': 'Participants received 400 mg of maribavir along with a placebo matched to valganciclovir, BID orally for 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '137', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=0.061', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage of Responders', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.0', 'ciLowerLimit': '-0.38', 'ciUpperLimit': '16.30', 'pValueComment': 'The CMH weighted average approach (stratified for baseline plasma CMV DNA concentration and acute GVHD status) was used for the adjusted difference in percentage of responders (Maribavir-Valganciclovir), the corresponding 95% CI, and the p-value.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 8', 'description': 'Confirmed CMV viremia clearance is defined as plasma CMV DNA concentrations less than lower limit of quantification (LLOQ; i.e. \\<137 International units per milliliter \\[IU/mL\\]), when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV Test in 2 consecutive post baseline samples separated by at least 5 days. To be considered a responder for this secondary endpoint, the participant must have received exclusively study-assigned treatment for 8 weeks. Participants who discontinued treatment early were non-responders for this endpoint.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified randomized set (i.e., the full analysis set) included all participants in the randomized set who took at least 1 dose of assigned study treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Achieved Confirmed CMV Viremia Clearance After Receiving 8 Weeks of Study-assigned Treatment Through Weeks 12, 16 and 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '273', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Valganciclovir 900 mg BID', 'description': 'Participants received 900 mg of valganciclovir along with a placebo matched to maribavir, BID orally for 8 weeks. Valganciclovir dose was allowed to be adjusted to 450 mg BID or 450 mg QD based on renal function impairment assessed at baseline or development of neutropenia during the study.'}, {'id': 'OG001', 'title': 'Maribavir 400 mg BID', 'description': 'Participants received 400 mg of maribavir along with a placebo matched to valganciclovir, BID orally for 8 weeks.'}], 'classes': [{'title': 'Week 8', 'categories': [{'measurements': [{'value': '137', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=0.061', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage of Responders', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.0', 'ciLowerLimit': '-0.38', 'ciUpperLimit': '16.30', 'pValueComment': 'The CMH weighted average approach (stratified for baseline plasma CMV DNA concentration and acute GVHD status) was used for the adjusted difference in percentage of responders (Maribavir-Valganciclovir), the corresponding 95% CI, and the p-value.', 'groupDescription': 'Week 8', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage of Responders', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.4', 'ciLowerLimit': '5.23', 'ciUpperLimit': '21.62', 'pValueComment': 'The CMH weighted average approach (stratified for baseline plasma CMV DNA concentration and acute GVHD status) was used for the adjusted difference in percentage of responders (Maribavir-Valganciclovir), the corresponding 95% CI, and the p-value.', 'groupDescription': 'Week 12', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage of Responders', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.8', 'ciLowerLimit': '5.80', 'ciUpperLimit': '21.87', 'pValueComment': 'The CMH weighted average approach (stratified for baseline plasma CMV DNA concentration and acute GVHD status) was used for the adjusted difference in percentage of responders (Maribavir-Valganciclovir), the corresponding 95% CI, and the p-value.', 'groupDescription': 'Week 16', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=0.014', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage of Responders', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.7', 'ciLowerLimit': '1.98', 'ciUpperLimit': '17.50', 'pValueComment': 'The CMH weighted average approach (stratified for baseline plasma CMV DNA concentration and acute GVHD status) was used for the adjusted difference in percentage of responders (Maribavir-Valganciclovir), the corresponding 95% CI, and the p-value.', 'groupDescription': 'Week 20', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 8 through Weeks 12, 16 and 20', 'description': 'Confirmed CMV viremia clearance is defined as plasma CMV DNA concentrations less than lower limit of quantification (LLOQ; i.e. \\<137 International units per milliliter \\[IU/mL\\]), when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV Test in 2 consecutive post baseline samples separated by at least 5 days. To be considered a responder for this secondary endpoint, the participant must have received exclusively study-assigned treatment for 8 weeks.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified randomized set (i.e., the full analysis set) included all participants in the randomized set who took at least 1 dose of assigned study treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Maintained Confirmed CMV Viremia Clearance at Week 8 After Receiving Study-Assigned Treatment Through Study Weeks 12 and 20 Regardless of Whether Study Assigned Treatment Was Completed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '273', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Valganciclovir 900 mg BID', 'description': 'Participants received 900 mg of valganciclovir along with a placebo matched to maribavir, BID orally for 8 weeks. Valganciclovir dose was allowed to be adjusted to 450 mg BID or 450 mg QD based on renal function impairment assessed at baseline or development of neutropenia during the study.'}, {'id': 'OG001', 'title': 'Maribavir 400 mg BID', 'description': 'Participants received 400 mg of maribavir along with a placebo matched to valganciclovir, BID orally for 8 weeks.'}], 'classes': [{'title': 'Week 8', 'categories': [{'measurements': [{'value': '211', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '157', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}]}, {'title': 'Week 20', 'categories': [{'measurements': [{'value': '116', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=0.051', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage of Responders', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.3', 'ciLowerLimit': '-14.64', 'ciUpperLimit': '0.02', 'pValueComment': 'The CMH weighted average approach (stratified for baseline plasma CMV DNA concentration and acute GVHD status) was used for the adjusted difference in percentage of responders (Maribavir-Valganciclovir), the corresponding 95% CI, and the p-value.', 'groupDescription': 'Week 8', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=0.606', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage of Responders', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.2', 'ciLowerLimit': '-6.05', 'ciUpperLimit': '10.37', 'pValueComment': 'The CMH weighted average approach (stratified for baseline plasma CMV DNA concentration and acute GVHD status) was used for the adjusted difference in percentage of responders (Maribavir-Valganciclovir), the corresponding 95% CI, and the p-value.', 'groupDescription': 'Week 12', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '=0.809', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage of Responders', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.0', 'ciLowerLimit': '-7.27', 'ciUpperLimit': '9.31', 'pValueComment': 'The CMH weighted average approach (stratified for baseline plasma CMV DNA concentration and acute GVHD status) was used for the adjusted difference in percentage of responders (Maribavir-Valganciclovir), the corresponding 95% CI, and the p-value.', 'groupDescription': 'Week 20', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 8 through Weeks 12 and 20', 'description': 'Confirmed CMV viremia clearance is defined as plasma CMV DNA concentrations less than lower limit of quantification (LLOQ; i.e. \\<137 International units per milliliter \\[IU/mL\\]), when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV Test in 2 consecutive post baseline samples separated by at least 5 days. To be considered a responder for this secondary endpoint, the participant must have received exclusively study-assigned treatment (regardless of whether the 8-week study-assigned treatment was completed or discontinued early) and had no symptoms of tissue invasive CMV disease at Week 8, Week 8 through Week 12, and Week 8 through Week 20, respectively.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified randomized set (i.e., the full analysis set) included all participants in the randomized set who took at least 1 dose of assigned study treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Confirmed Recurrence of Viremia During First 8 Weeks of the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Valganciclovir 900 mg BID', 'description': 'Participants received 900 mg of valganciclovir along with a placebo matched to maribavir, BID orally for 8 weeks. Valganciclovir dose was allowed to be adjusted to 450 mg BID or 450 mg QD based on renal function impairment assessed at baseline or development of neutropenia during the study.'}, {'id': 'OG001', 'title': 'Maribavir 400 mg BID', 'description': 'Participants received 400 mg of maribavir along with a placebo matched to valganciclovir, BID orally for 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 8', 'description': 'Recurrence of CMV viremia is defined as plasma CMV DNA concentration greater than or equal to (\\>=) lower limit of quantification (LLOQ, i.e. \\>=137 International units per milliliter \\[IU/mL\\]) when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV Test in 2 consecutive plasma samples at least 5 days apart, after being unquantifiable (\\<LLOQ, i.e. \\<137 IU/mL) for at least 5 days in 2 consecutive samples during the first 8 weeks of the study, during the 12 weeks of the follow up study phase, and at any time during the study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number analyzed is the subset of participants from the modified randomized set (all participants in the randomized set who took at least 1 dose of study-assigned treatment) who achieved confirmed viremia clearance.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Confirmed Recurrence of Viremia During the Follow-up Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Valganciclovir 900 mg BID', 'description': 'Participants received 900 mg of valganciclovir along with a placebo matched to maribavir, BID orally for 8 weeks. Valganciclovir dose was allowed to be adjusted to 450 mg BID or 450 mg QD based on renal function impairment assessed at baseline or development of neutropenia during the study.'}, {'id': 'OG001', 'title': 'Maribavir 400 mg BID', 'description': 'Participants received 400 mg of maribavir along with a placebo matched to valganciclovir, BID orally for 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Week 9 up to Week 20', 'description': 'Recurrence of CMV viremia is defined as plasma CMV DNA concentration greater than or equal to (\\>=) LLOQ when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV Test in 2 consecutive plasma samples at least 5 days apart, after being unquantifiable (\\<LLOQ) for at least 5 days in 2 consecutive samples during the first 8 weeks of the study, during the 12 weeks of the follow up study phase, and at any time during the study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number analyzed is the subset of participants from the modified randomized set (all participants in the randomized set who took at least 1 dose of study-assigned treatment) who achieved confirmed viremia clearance.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Confirmed Recurrence of Viremia at Any Time During the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Valganciclovir 900 mg BID', 'description': 'Participants received 900 mg of valganciclovir along with a placebo matched to maribavir, BID orally for 8 weeks. Valganciclovir dose was allowed to be adjusted to 450 mg BID or 450 mg QD based on renal function impairment assessed at baseline or development of neutropenia during the study.'}, {'id': 'OG001', 'title': 'Maribavir 400 mg BID', 'description': 'Participants received 400 mg of maribavir along with a placebo matched to valganciclovir, BID orally for 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 20', 'description': 'Recurrence of CMV viremia is defined as plasma CMV DNA concentration greater than or equal to (\\>=) LLOQ when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV Test in 2 consecutive plasma samples at least 5 days apart, after being unquantifiable (\\<LLOQ) for at least 5 days in 2 consecutive samples during the first 8 weeks of the study, during the 12 weeks of the follow up study phase, and at any time during the study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number analyzed is the subset of participants from the modified randomized set (all participants in the randomized set who took at least 1 dose of study-assigned treatment) who achieved confirmed viremia clearance.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Confirmed Recurrence of Viremia While on Study Treatment and Off Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Valganciclovir 900 mg BID', 'description': 'Participants received 900 mg of valganciclovir along with a placebo matched to maribavir, BID orally for 8 weeks. Valganciclovir dose was allowed to be adjusted to 450 mg BID or 450 mg QD based on renal function impairment assessed at baseline or development of neutropenia during the study.'}, {'id': 'OG001', 'title': 'Maribavir 400 mg BID', 'description': 'Participants received 400 mg of maribavir along with a placebo matched to valganciclovir, BID orally for 8 weeks.'}], 'classes': [{'title': 'On Study Treatment', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Off Study Treatment', 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to Week 20', 'description': 'Recurrence of CMV viremia is defined as plasma CMV DNA concentration greater than or equal to (\\>=) LLOQ when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV Test in 2 consecutive plasma samples at least 5 days apart, after being unquantifiable (\\<LLOQ) for at least 5 days in 2 consecutive samples during the first 8 weeks of the study, during the 12 weeks of the follow up study phase, and at any time during the study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number analyzed is the subset of participants from the modified randomized set (all participants in the randomized set who took at least 1 dose of study-assigned treatment) who achieved confirmed viremia clearance.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Grade 3 or 4 (Shift From Baseline Grade <3) and Grade 4 Neutropenia (Shift From Baseline Grade <4) While on Study Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '273', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Valganciclovir 900 mg BID', 'description': 'Participants received 900 mg of valganciclovir along with a placebo matched to maribavir, BID orally for 8 weeks. Valganciclovir dose was allowed to be adjusted to 450 mg BID or 450 mg QD based on renal function impairment assessed at baseline or development of neutropenia during the study.'}, {'id': 'OG001', 'title': 'Maribavir 400 mg BID', 'description': 'Participants received 400 mg of maribavir along with a placebo matched to valganciclovir, BID orally for 8 weeks.'}], 'classes': [{'title': 'Grade 3 or Grade 4 Neutropenia', 'categories': [{'measurements': [{'value': '137', 'groupId': 'OG000', 'lowerLimit': '44.08', 'upperLimit': '55.92'}, {'value': '44', 'groupId': 'OG001', 'lowerLimit': '11.76', 'upperLimit': '20.48'}]}]}, {'title': 'Grade 4 Neutropenia', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000', 'lowerLimit': '17.34', 'upperLimit': '27.19'}, {'value': '9', 'groupId': 'OG001', 'lowerLimit': '1.18', 'upperLimit': '5.41'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From start of study drug to end of study drug + 1 day (up to approximately Week 8)', 'description': 'Grade 3 and grade 4 neutropenia are defined as absolute neutrophil count (ANC) \\<1000 per cubic millimeter (/mm\\^3) and ANC \\<500/mm\\^3 respectively. Incidence of Grade 3 or 4 neutropenia represents the percentage of participants with Grade \\<3 (or missing) neutropenia at baseline, but Grade 3 or 4 while on study treatment. Incidence of Grade 4 neutropenia represents the number of participants with Grade \\<4 (or missing) neutropenia at baseline, but Grade 4 while on study treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set included all participants who took at least 1 dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Events During the On-Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '273', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Valganciclovir 900 mg BID', 'description': 'Participants received 900 mg of valganciclovir along with a placebo matched to maribavir, BID orally for 8 weeks. Valganciclovir dose was allowed to be adjusted to 450 mg BID or 450 mg QD based on renal function impairment assessed at baseline or development of neutropenia during the study.'}, {'id': 'OG001', 'title': 'Maribavir 400 mg BID', 'description': 'Participants received 400 mg of maribavir along with a placebo matched to valganciclovir, BID orally for 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '269', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the start of the study treatment to 7 days after the last dose of study treatment (up to approximately Week 9)', 'description': 'An adverse event (AE) is any untoward medical occurrence in a clinical investigation participants administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE that has a start date on or after the first dose of study treatment, or that has a start date before the date of first dose of study treatment but increases in severity after the first dose of study treatment, will be considered a treatment-emergent AE (TEAE).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set included all participants who took at least 1 dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'Predose Concentration (Cmin) of Maribavir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Maribavir 400 mg BID', 'description': 'Participants received 400 mg of maribavir along with a placebo matched to valganciclovir, BID orally for 8 weeks.'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.17', 'spread': '7.69', 'groupId': 'OG000'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.71', 'spread': '9.20', 'groupId': 'OG000'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.02', 'spread': '6.35', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 1, 4, and 8: pre-morning dose', 'description': 'The primary plasma maribavir concentration dataset (primary concentration dataset) includes all plasma maribavir concentrations. Missing PK sampling times are imputed according to the sparse sampling schedule in primary concentration dataset.', 'unitOfMeasure': 'micrograms per milliliter (µg/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) Set included all participants in the safety set who received maribavir treatment and had plasma samples drawn and tested for maribavir concentrations. Overall number analyzed is the number of participants available for analyses. Number analyzed is the number of participants available for analyses at the given timepoint.'}, {'type': 'SECONDARY', 'title': 'Area Under the Concentration-Time Curve Over the 12-Hour Dosing Interval at Steady State AUC(0-tau) of Maribavir for Adolescent Participants Only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Maribavir 400 mg BID', 'description': 'Participants received 400 mg of maribavir along with a placebo matched to valganciclovir, BID orally for 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '161', 'groupId': 'OG000', 'lowerLimit': '161', 'upperLimit': '161'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-morning dose, 1, 2, 3, 4, 6, 8, and 12 hours post-morning dose of Week 1', 'unitOfMeasure': 'hours (h)*μg/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'An adolescent PK set consisted of all participants of ≥16 to \\<18 years of age in the safety set who received maribavir treatment and had plasma samples drawn and tested for maribavir concentrations. Overall number analyzed is the number of participants available for analyses.'}, {'type': 'SECONDARY', 'title': 'Maximum Observed Plasma Concentration (Cmax) of Maribavir for Adolescent Participants Only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Maribavir 400 mg BID', 'description': 'Participants received 400 mg of maribavir along with a placebo matched to valganciclovir, BID orally for 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.0', 'groupId': 'OG000', 'lowerLimit': '22.0', 'upperLimit': '22.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-morning dose, 1, 2, 3, 4, 6, 8, and 12 hours post-morning dose of Week 1', 'unitOfMeasure': 'µg/mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'An adolescent PK set consisted of all participants of ≥16 to \\<18 years of age in the safety set who received maribavir treatment and had plasma samples drawn and tested for maribavir concentrations. Overall number analyzed is the number of participants available for analyses.'}, {'type': 'SECONDARY', 'title': 'Time When Maximum Concentration is Observed (Tmax) of Maribavir for Adolescent Participants Only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Maribavir 400 mg BID', 'description': 'Participants received 400 mg of maribavir along with a placebo matched to valganciclovir, BID orally for 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.92', 'groupId': 'OG000', 'lowerLimit': '0.92', 'upperLimit': '0.92'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-morning dose, 1, 2, 3, 4, 6, 8, and 12 hours post-morning dose of Week 1', 'unitOfMeasure': 'hours (h)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'An adolescent PK set consisted of all participants of ≥16 to \\<18 years of age in the safety set who received maribavir treatment and had plasma samples drawn and tested for maribavir concentrations. Overall number analyzed is the number of participants available for analyses.'}, {'type': 'SECONDARY', 'title': 'Apparent Oral Clearance (CL/F) of Maribavir for Adolescent Participants Only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Maribavir 400 mg BID', 'description': 'Participants received 400 mg of maribavir along with a placebo matched to valganciclovir; BID orally for 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.49', 'groupId': 'OG000', 'lowerLimit': '2.49', 'upperLimit': '2.49'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-morning dose, 1, 2, 3, 4, 6, 8, and 12 hours post-morning dose of Week 1', 'unitOfMeasure': 'liters per hour (L/h)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'An adolescent PK set consisted of all participants of ≥16 to \\<18 years of age in the safety set who received maribavir treatment and had plasma samples drawn and tested for maribavir concentrations. Overall number analyzed is the number of participants available for analyses.'}, {'type': 'SECONDARY', 'title': 'Apparent Volume of Distribution (Vz/F) of Maribavir for Adolescent Participants Only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Maribavir 400 mg BID', 'description': 'Participants received 400 mg of maribavir along with a placebo matched to valganciclovir, BID orally for 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.3', 'groupId': 'OG000', 'lowerLimit': '18.3', 'upperLimit': '18.3'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-morning dose, 1, 2, 3, 4, 6, 8, and 12 hours post-morning dose of Week 1', 'unitOfMeasure': 'liters (L)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'An adolescent PK set consisted of all participants of ≥16 to \\<18 years of age in the safety set who received maribavir treatment and had plasma samples drawn and tested for maribavir concentrations. Overall number analyzed is the number of participants available for analyses.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants Developing Resistance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '274', 'groupId': 'OG000'}, {'value': '273', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Valganciclovir 900 mg BID', 'description': 'Participants received 900 mg of valganciclovir along with a placebo matched to maribavir, BID orally for 8 weeks. Valganciclovir dose was allowed to be adjusted to 450 mg BID or 450 mg QD based on renal function impairment assessed at baseline or development of neutropenia during the study.'}, {'id': 'OG001', 'title': 'Maribavir 400 mg BID', 'description': 'Participants received 400 mg of maribavir along with a placebo matched to valganciclovir, BID orally for 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From start of study drug up to end of the study (up to Week 20)', 'description': 'Resistance was defined as the presence of any CMV resistance-associated amino acid substitution that has been documented (or suspected) to be associated with reduced susceptibility to conventional anti-CMV therapies (ganciclovir/valganciclovir, foscarnet, and cidofovir) or maribavir. Genotypic resistance analyses were restricted to sequence variants that were known or suspected to be associated with resistance to conventional anti-CMV therapies or maribavir as of January 21, 2022. A participant was categorized as having developed resistance if the central lab genotyping results indicated the presence of one or more treatment-emergent resistance mutations.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set included all participants who took at least 1 dose of study treatment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Valganciclovir 900 mg BID', 'description': 'Participants received 900 milligrams (mg) of valganciclovir along with a placebo matched to maribavir, twice daily (BID) orally for 8 weeks. Valganciclovir dose was allowed to be adjusted to 450 mg BID or 450 mg QD based on renal function impairment assessed at baseline or development of neutropenia during the study.'}, {'id': 'FG001', 'title': 'Maribavir 400 mg BID', 'description': 'Participants received 400 mg of maribavir along with a placebo matched to valganciclovir, BID orally for 8 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '277'}, {'groupId': 'FG001', 'numSubjects': '276'}]}, {'type': 'Treated Participants', 'comment': 'Treated participants (full analysis set) included the participants from the randomized set who took at least one dose of assigned study drug and were analyzed for efficacy and safety evaluations.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '274'}, {'groupId': 'FG001', 'numSubjects': '273'}]}, {'type': 'Participants Received 8 Weeks Treatment', 'comment': 'Participants who received 8 weeks of treatment include the participants who completed study drug treatment.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '140'}, {'groupId': 'FG001', 'numSubjects': '179'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '217'}, {'groupId': 'FG001', 'numSubjects': '215'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '61'}]}], 'dropWithdraws': [{'type': 'Withdrawn Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Noncompliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Reason not Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}], 'recruitmentDetails': 'Participants were randomized at 97 sites in United States,Spain,France,Germany,United Kingdom,Belgium,China,Italy,Israel,Australia,Canada,Singapore,Croatia, Czech Republic,Greece,Hungary,Korea,New Zealand,Poland,Russia,Switzerland, and Turkey from 14 April 2017(first participant first visit) to 01 July 2022(last participant last visit).', 'preAssignmentDetails': 'Participants who were hematopoietic stem cell transplant (HSCT) recipients with a diagnosis of asymptomatic cytomegalovirus (CMV) infection were enrolled then randomized in a 1:1 ratio to receive either maribavir or valganciclovir (along with placebo matched to comparator) in each arm in a double-blind, double-dummy fashion.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'BG000'}, {'value': '276', 'groupId': 'BG001'}, {'value': '553', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Valganciclovir 900 mg BID', 'description': 'Participants received 900 mg of valganciclovir along with a placebo matched to maribavir, BID orally for 8 weeks. Valganciclovir dose was allowed to be adjusted to 450 mg BID or 450 mg QD based on renal function impairment assessed at baseline or development of neutropenia during the study.'}, {'id': 'BG001', 'title': 'Maribavir 400 mg BID', 'description': 'Participants received 400 mg of maribavir along with a placebo matched to valganciclovir, BID orally for 8 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'BG000'}, {'value': '276', 'groupId': 'BG001'}, {'value': '553', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '51.8', 'spread': '15.22', 'groupId': 'BG000'}, {'value': '53.1', 'spread': '13.96', 'groupId': 'BG001'}, {'value': '52.5', 'spread': '14.61', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'BG000'}, {'value': '276', 'groupId': 'BG001'}, {'value': '553', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '110', 'groupId': 'BG000'}, {'value': '126', 'groupId': 'BG001'}, {'value': '236', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '167', 'groupId': 'BG000'}, {'value': '150', 'groupId': 'BG001'}, {'value': '317', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'BG000'}, {'value': '276', 'groupId': 'BG001'}, {'value': '553', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '193', 'groupId': 'BG000'}, {'value': '216', 'groupId': 'BG001'}, {'value': '409', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'BG000'}, {'value': '276', 'groupId': 'BG001'}, {'value': '553', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '200', 'groupId': 'BG000'}, {'value': '221', 'groupId': 'BG001'}, {'value': '421', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Australia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'BG000'}, {'value': '276', 'groupId': 'BG001'}, {'value': '553', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}, {'title': 'China', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'BG000'}, {'value': '276', 'groupId': 'BG001'}, {'value': '553', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}, {'title': 'Korea, South', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'BG000'}, {'value': '276', 'groupId': 'BG001'}, {'value': '553', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'New Zealand', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'BG000'}, {'value': '276', 'groupId': 'BG001'}, {'value': '553', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}, {'title': 'Belgium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'BG000'}, {'value': '276', 'groupId': 'BG001'}, {'value': '553', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}]}, {'title': 'Switzerland', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'BG000'}, {'value': '276', 'groupId': 'BG001'}, {'value': '553', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Czech Republic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'BG000'}, {'value': '276', 'groupId': 'BG001'}, {'value': '553', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'BG000'}, {'value': '276', 'groupId': 'BG001'}, {'value': '553', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}, {'title': 'Spain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'BG000'}, {'value': '276', 'groupId': 'BG001'}, {'value': '553', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '130', 'groupId': 'BG002'}]}]}, {'title': 'France', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'BG000'}, {'value': '276', 'groupId': 'BG001'}, {'value': '553', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'BG000'}, {'value': '276', 'groupId': 'BG001'}, {'value': '553', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}, {'title': 'Greece', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'BG000'}, {'value': '276', 'groupId': 'BG001'}, {'value': '553', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Croatia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'BG000'}, {'value': '276', 'groupId': 'BG001'}, {'value': '553', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Hungary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'BG000'}, {'value': '276', 'groupId': 'BG001'}, {'value': '553', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Israel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'BG000'}, {'value': '276', 'groupId': 'BG001'}, {'value': '553', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Italy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'BG000'}, {'value': '276', 'groupId': 'BG001'}, {'value': '553', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'Poland', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'BG000'}, {'value': '276', 'groupId': 'BG001'}, {'value': '553', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Russia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'BG000'}, {'value': '276', 'groupId': 'BG001'}, {'value': '553', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Turkey', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'BG000'}, {'value': '276', 'groupId': 'BG001'}, {'value': '553', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'Canada', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'BG000'}, {'value': '276', 'groupId': 'BG001'}, {'value': '553', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'BG000'}, {'value': '276', 'groupId': 'BG001'}, {'value': '553', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}]}]}, {'title': 'Singapore', 'denoms': [{'units': 'Participants', 'counts': [{'value': '277', 'groupId': 'BG000'}, {'value': '276', 'groupId': 'BG001'}, {'value': '553', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Height', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'BG000'}, {'value': '267', 'groupId': 'BG001'}, {'value': '531', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '169.58', 'spread': '9.391', 'groupId': 'BG000'}, {'value': '168.75', 'spread': '9.579', 'groupId': 'BG001'}, {'value': '169.17', 'spread': '9.486', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Number analyzed is the number of participants with data available for analysis for height.'}, {'title': 'Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'BG000'}, {'value': '275', 'groupId': 'BG001'}, {'value': '545', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '70.31', 'spread': '15.247', 'groupId': 'BG000'}, {'value': '70.98', 'spread': '16.779', 'groupId': 'BG001'}, {'value': '70.65', 'spread': '16.027', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Number analyzed is the number of participants with data available for analysis for weight.'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'BG000'}, {'value': '266', 'groupId': 'BG001'}, {'value': '529', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '24.38', 'spread': '4.628', 'groupId': 'BG000'}, {'value': '24.90', 'spread': '5.007', 'groupId': 'BG001'}, {'value': '24.64', 'spread': '4.825', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'BMI = Body Mass Index. It is computed by \\[weight (kg) / height (cm)\\^2\\] x 10,000.', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Number analyzed is the number of participants with data available for analysis for BMI.'}], 'populationDescription': 'Randomized set included all participants in the enrolled set for whom a randomization number had been assigned.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-09-15', 'size': 5527351, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-12-14T08:56', 'hasProtocol': True}, {'date': '2022-04-27', 'size': 1276293, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-12-14T08:56', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 553}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-02', 'studyFirstSubmitDate': '2016-09-29', 'resultsFirstSubmitDate': '2022-12-19', 'studyFirstSubmitQcDate': '2016-10-05', 'lastUpdatePostDateStruct': {'date': '2023-03-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-02-02', 'studyFirstPostDateStruct': {'date': '2016-10-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Participants Developing Resistance', 'timeFrame': 'From start of study drug up to end of the study (up to Week 20)', 'description': 'Resistance was defined as the presence of any CMV resistance-associated amino acid substitution that has been documented (or suspected) to be associated with reduced susceptibility to conventional anti-CMV therapies (ganciclovir/valganciclovir, foscarnet, and cidofovir) or maribavir. Genotypic resistance analyses were restricted to sequence variants that were known or suspected to be associated with resistance to conventional anti-CMV therapies or maribavir as of January 21, 2022. A participant was categorized as having developed resistance if the central lab genotyping results indicated the presence of one or more treatment-emergent resistance mutations.'}], 'primaryOutcomes': [{'measure': 'Number of Participants Who Achieved Confirmed Clearance of Plasma Cytomegalovirus (CMV) Deoxyribose Nucleic Acid (DNA) at the End of Study Week 8', 'timeFrame': 'Week 8', 'description': 'Confirmed CMV viremia clearance is defined as plasma CMV DNA concentrations less than lower limit of quantification (LLOQ; i.e. \\<137 International units per milliliter \\[IU/mL\\]), when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV Test in 2 consecutive post baseline samples separated by at least 5 days. To be considered a responder for the primary endpoint, the participant must have received exclusively study-assigned treatment (regardless of whether study-assigned treatment was completed).'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Who Achieved Confirmed CMV Viremia Clearance and CMV Infection Symptom Control at the End of Week 8, Followed by Maintenance of Treatment Effect at Week 16', 'timeFrame': 'Week 8 up to Week 16', 'description': 'Confirmed CMV viremia clearance is defined as plasma CMV DNA concentrations less than lower limit of quantification (LLOQ; i.e. \\<137 International units per milliliter \\[IU/mL\\]), when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV Test in 2 consecutive post baseline samples separated by at least 5 days. To be considered a responder for this key secondary endpoint, the participant must have received exclusively study-assigned treatment (regardless of whether study-assigned treatment was completed). CMV Infection Symptom Control is defined as no new clinical findings of CMV tissue invasive disease. Maintenance of Treatment Effect is defined as maintaining confirmed CMV viremia clearance and CMV infection symptom control through Week 16.'}, {'measure': 'Number of Participants Who Achieved Confirmed Clearance of Plasma CMV DNA (CMV Viremia Clearance) at Week 8 After Receiving 8 Weeks of Study Assigned Treatment', 'timeFrame': 'Week 8', 'description': 'Confirmed CMV viremia clearance is defined as plasma CMV DNA concentrations less than lower limit of quantification (LLOQ; i.e. \\<137 International units per milliliter \\[IU/mL\\]), when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV Test in 2 consecutive post baseline samples separated by at least 5 days. To be considered a responder for this secondary endpoint, the participant must have received exclusively study-assigned treatment for 8 weeks. Participants who discontinued treatment early were non-responders for this endpoint.'}, {'measure': 'Number of Participants Who Achieved Confirmed CMV Viremia Clearance After Receiving 8 Weeks of Study-assigned Treatment Through Weeks 12, 16 and 20', 'timeFrame': 'Week 8 through Weeks 12, 16 and 20', 'description': 'Confirmed CMV viremia clearance is defined as plasma CMV DNA concentrations less than lower limit of quantification (LLOQ; i.e. \\<137 International units per milliliter \\[IU/mL\\]), when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV Test in 2 consecutive post baseline samples separated by at least 5 days. To be considered a responder for this secondary endpoint, the participant must have received exclusively study-assigned treatment for 8 weeks.'}, {'measure': 'Number of Participants Who Maintained Confirmed CMV Viremia Clearance at Week 8 After Receiving Study-Assigned Treatment Through Study Weeks 12 and 20 Regardless of Whether Study Assigned Treatment Was Completed', 'timeFrame': 'Week 8 through Weeks 12 and 20', 'description': 'Confirmed CMV viremia clearance is defined as plasma CMV DNA concentrations less than lower limit of quantification (LLOQ; i.e. \\<137 International units per milliliter \\[IU/mL\\]), when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV Test in 2 consecutive post baseline samples separated by at least 5 days. To be considered a responder for this secondary endpoint, the participant must have received exclusively study-assigned treatment (regardless of whether the 8-week study-assigned treatment was completed or discontinued early) and had no symptoms of tissue invasive CMV disease at Week 8, Week 8 through Week 12, and Week 8 through Week 20, respectively.'}, {'measure': 'Number of Participants With Confirmed Recurrence of Viremia During First 8 Weeks of the Study', 'timeFrame': 'Up to Week 8', 'description': 'Recurrence of CMV viremia is defined as plasma CMV DNA concentration greater than or equal to (\\>=) lower limit of quantification (LLOQ, i.e. \\>=137 International units per milliliter \\[IU/mL\\]) when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV Test in 2 consecutive plasma samples at least 5 days apart, after being unquantifiable (\\<LLOQ, i.e. \\<137 IU/mL) for at least 5 days in 2 consecutive samples during the first 8 weeks of the study, during the 12 weeks of the follow up study phase, and at any time during the study.'}, {'measure': 'Number of Participants With Confirmed Recurrence of Viremia During the Follow-up Period', 'timeFrame': 'From Week 9 up to Week 20', 'description': 'Recurrence of CMV viremia is defined as plasma CMV DNA concentration greater than or equal to (\\>=) LLOQ when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV Test in 2 consecutive plasma samples at least 5 days apart, after being unquantifiable (\\<LLOQ) for at least 5 days in 2 consecutive samples during the first 8 weeks of the study, during the 12 weeks of the follow up study phase, and at any time during the study.'}, {'measure': 'Number of Participants With Confirmed Recurrence of Viremia at Any Time During the Study', 'timeFrame': 'Up to Week 20', 'description': 'Recurrence of CMV viremia is defined as plasma CMV DNA concentration greater than or equal to (\\>=) LLOQ when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV Test in 2 consecutive plasma samples at least 5 days apart, after being unquantifiable (\\<LLOQ) for at least 5 days in 2 consecutive samples during the first 8 weeks of the study, during the 12 weeks of the follow up study phase, and at any time during the study.'}, {'measure': 'Number of Participants With Confirmed Recurrence of Viremia While on Study Treatment and Off Treatment', 'timeFrame': 'Baseline up to Week 20', 'description': 'Recurrence of CMV viremia is defined as plasma CMV DNA concentration greater than or equal to (\\>=) LLOQ when assessed by COBAS® AmpliPrep/COBAS® TaqMan® CMV Test in 2 consecutive plasma samples at least 5 days apart, after being unquantifiable (\\<LLOQ) for at least 5 days in 2 consecutive samples during the first 8 weeks of the study, during the 12 weeks of the follow up study phase, and at any time during the study.'}, {'measure': 'Number of Participants With Grade 3 or 4 (Shift From Baseline Grade <3) and Grade 4 Neutropenia (Shift From Baseline Grade <4) While on Study Treatment', 'timeFrame': 'From start of study drug to end of study drug + 1 day (up to approximately Week 8)', 'description': 'Grade 3 and grade 4 neutropenia are defined as absolute neutrophil count (ANC) \\<1000 per cubic millimeter (/mm\\^3) and ANC \\<500/mm\\^3 respectively. Incidence of Grade 3 or 4 neutropenia represents the percentage of participants with Grade \\<3 (or missing) neutropenia at baseline, but Grade 3 or 4 while on study treatment. Incidence of Grade 4 neutropenia represents the number of participants with Grade \\<4 (or missing) neutropenia at baseline, but Grade 4 while on study treatment.'}, {'measure': 'Number of Participants With Treatment-Emergent Adverse Events During the On-Treatment Period', 'timeFrame': 'From the start of the study treatment to 7 days after the last dose of study treatment (up to approximately Week 9)', 'description': 'An adverse event (AE) is any untoward medical occurrence in a clinical investigation participants administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE that has a start date on or after the first dose of study treatment, or that has a start date before the date of first dose of study treatment but increases in severity after the first dose of study treatment, will be considered a treatment-emergent AE (TEAE).'}, {'measure': 'Predose Concentration (Cmin) of Maribavir', 'timeFrame': 'Weeks 1, 4, and 8: pre-morning dose', 'description': 'The primary plasma maribavir concentration dataset (primary concentration dataset) includes all plasma maribavir concentrations. Missing PK sampling times are imputed according to the sparse sampling schedule in primary concentration dataset.'}, {'measure': 'Area Under the Concentration-Time Curve Over the 12-Hour Dosing Interval at Steady State AUC(0-tau) of Maribavir for Adolescent Participants Only', 'timeFrame': 'Pre-morning dose, 1, 2, 3, 4, 6, 8, and 12 hours post-morning dose of Week 1'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax) of Maribavir for Adolescent Participants Only', 'timeFrame': 'Pre-morning dose, 1, 2, 3, 4, 6, 8, and 12 hours post-morning dose of Week 1'}, {'measure': 'Time When Maximum Concentration is Observed (Tmax) of Maribavir for Adolescent Participants Only', 'timeFrame': 'Pre-morning dose, 1, 2, 3, 4, 6, 8, and 12 hours post-morning dose of Week 1'}, {'measure': 'Apparent Oral Clearance (CL/F) of Maribavir for Adolescent Participants Only', 'timeFrame': 'Pre-morning dose, 1, 2, 3, 4, 6, 8, and 12 hours post-morning dose of Week 1'}, {'measure': 'Apparent Volume of Distribution (Vz/F) of Maribavir for Adolescent Participants Only', 'timeFrame': 'Pre-morning dose, 1, 2, 3, 4, 6, 8, and 12 hours post-morning dose of Week 1'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cytomegalovirus (CMV)']}, 'referencesModule': {'references': [{'pmid': '39302855', 'type': 'DERIVED', 'citation': 'Chou S, Winston DJ, Avery RK, Cordonnier C, Duarte RF, Haider S, Maertens J, Peggs KS, Solano C, Young JH, Gu J, Pocock G, Papanicolaou GA. Comparative Emergence of Maribavir and Ganciclovir Resistance in a Randomized Phase 3 Clinical Trial for Treatment of Cytomegalovirus Infection. J Infect Dis. 2025 Mar 17;231(3):e470-e477. doi: 10.1093/infdis/jiae469.'}, {'pmid': '38036487', 'type': 'DERIVED', 'citation': 'Papanicolaou GA, Avery RK, Cordonnier C, Duarte RF, Haider S, Maertens J, Peggs KS, Solano C, Young JH, Fournier M, Murray RA, Wu J, Winston DJ; AURORA Trial Investigators. Treatment for First Cytomegalovirus Infection Post-Hematopoietic Cell Transplant in the AURORA Trial: A Multicenter, Double-Blind, Randomized, Phase 3 Trial Comparing Maribavir With Valganciclovir. Clin Infect Dis. 2024 Mar 20;78(3):562-572. doi: 10.1093/cid/ciad709.'}, {'pmid': '37899366', 'type': 'DERIVED', 'citation': "Stewart AG, Kotton CN. What's New: Updates on Cytomegalovirus in Solid Organ Transplantation. Transplantation. 2024 Apr 1;108(4):884-897. doi: 10.1097/TP.0000000000004855. Epub 2023 Oct 30."}], 'seeAlsoLinks': [{'url': 'https://clinicaltrials.takeda.com/study-detail/5f6b5fd74db2bf003ab46ecf', 'label': 'To obtain more information on the study, click here/on this link'}]}, 'descriptionModule': {'briefSummary': 'This study is about treatment options for cytomegalovirus infections in people who have received stem cell transplants. The main aim of the study is to check if the cytomegalovirus infection can no longer be detected after treatment with marivabir or valganciclovir.\n\nParticipants will take 2 tablets of marivabir or valganciclovir and 2 tablets of placebo twice a day for 8 weeks. A placebo will look like marivabir or valganciclovir but will not have any medicine in it.\n\nAfter treatment, each participant will be followed up for up to 12 weeks.\n\nParticipants will visit their study clinic up to 18 times during the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Be able to provide written, personally signed, and dated informed consent to participate in the study before completing any study-related procedures. As applicable, a parent/both parents or legally authorized representative (LAR) must provide signature of informed consent and there must be documentation of assent by the participants before completing any study-related procedures. During the COVID-19 public health emergency, informed consent from a potential or current trial participant may, if permitted by local laws and regulations, be obtained via electronic informed consent (eIC) capabilities or an electronic face-to-face consent interview when these individuals are unable to travel to the site (FDA COVID-19 Guidance, 27 January 2021, Q11).\n* Be greater than or equal to (\\>=) 16 years of age at the time of consent.\n* Be a recipient of hematopoietic stem cell transplant.\n* Have a documented asymptomatic CMV infection, with a screening value of CMV DNA \\>=1365 International Units per millilitre (IU/mL) to less than or equal to (\\<=) 273000 IU/mL in whole blood or \\>=455 IU/mL to \\<=91000 IU/mL in plasma in 2 consecutive assessments, separated by at least 1 day, as determined by local or central specialty laboratory quantitative polymerase chain reaction (qPCR) or comparable quantitative CMV DNA results. Both samples should be taken within 14 days prior to randomization with second sample obtained within 5 days prior to randomization. Same laboratory and same sample type (whole blood or plasma) should be used for these assessments. Asymptomatic CMV infection is defined as an infection that does not present with tissue invasive CMV disease, as assessed by the investigator. Participants with CMV DNA less than (\\<) 910 and \\>=455 IU/mL in plasma or \\<2730 and \\>=1365 IU/mL in whole blood will also need to meet at least 1 of the following criteria for high-risk CMV infection to be eligible:\n\n 1. Human leukocyte antigen (HLA)-related (sibling) donor with at least 1 mismatch at 1 of the following 3 HLA-gene loci: HLA-A, -B or -DR,\n 2. Haploidentical donor\n 3. Unrelated donor with at least 1 mismatch at 1 of the following 4 HLA -gene loci: HLA-A, -B, -C and -DRB1,\n 4. Use of umbilical cord blood as stem cell source,\n 5. Use of ex vivo T-cell-depleted grafts,\n 6. Grade 2 or greater graft-versus-host-disease (GVHD), requiring the use of systemic corticosteroids (defined as the use of \\>=1 milligram per kilogram per day (mg/kg/day) of prednisone or equivalent dose of another corticosteroid).\n* Have the current CMV infection as the first episode of CMV viremia after HSCT, either primary or reactivation, which in the investigator's opinion requires treatment.\n* Per investigator's judgment, be eligible for treatment with valganciclovir.\n* Have all of the following results as part of screening laboratory assessments (results from either the central laboratory or a local laboratory can be used for qualification):\n\n 1. Absolute neutrophil count to \\>=1000 per cubic millimeter (/mm\\^3) \\[1.0\\*10\\^9/L\\].\n 2. Platelet count \\>=25,000/mm\\^3 \\[25\\*10\\^9/L\\].\n 3. Hemoglobin \\>=8 grams per deciliter (g/dL).\n 4. Estimated creatinine clearance \\>=30 milliliters per minute (mL/min).\n* Have a negative serum beta human chorionic gonadotropin (beta-HCG) pregnancy test at screening, if a female of child bearing potential. Urine pregnancy tests may be done per institutional requirements; however they are not sufficient for eligibility determination. Sexually active females of child bearing potential must agree to comply with any applicable contraceptive requirements of the protocol. If male, must agree to use an acceptable method of birth control, as defined in the protocol, during the study treatment administration period and for 90 days afterward the last dose of study treatment.\n* Be able to swallow tablets.\n* Have life expectancy of \\>=8 weeks.\n* Weigh \\>=40 kilograms (kg).\n* Be willing and have an understanding and ability to fully comply with study procedures and restrictions defined in the protocol.\n\nExclusion Criteria:\n\n* Have CMV tissue invasive disease as assessed by the investigator at the time of screening and randomization at Visit 2/Day 0.\n* Have a CMV infection that is known to be genotypically resistant to ganciclovir, valganciclovir, foscarnet, or cidofovir based on documented evidence.\n* Be presenting with recurrent CMV infection (defined as a new detection of CMV infection in a participants who had at least one previously documented episode of CMV infection post-transplant, and who has had at least 2 weeks of undetectable CMV DNA between the episodes during active surveillance, based on same local laboratory and same sample type). The Participants must also have been off any anti-CMV treatment between the current and prior infection. Otherwise, the current infection may be considered continuation of the prior infection.\n* Require ganciclovir, valganciclovir, foscarnet, or cidofovir administration for conditions other than CMV when study treatment is initiated (example: herpes simplex virus \\[HSV\\] co-infection requiring use of any of these agents after the randomization) or would need a co-administration with maribavir for CMV infection.\n* Be receiving leflunomide, letermovir, or artesunate when study treatment is initiated.\n\nNote: Participants who may be receiving leflunomide must discontinue the use at least 14 days prior to randomization at Visit 2/Day 0 and the first dose of study treatment. Participants receiving letermovir must discontinue use 3 days prior to first dose of study treatment. Participants receiving artesunate must discontinue the use prior to the first dose of study treatment.\n\n* Be on treatment with anti-CMV agents (ganciclovir, valganciclovir, foscarnet or letermovir) for the current CMV infection for longer than 72 hours.\n* Have known hypersensitivity to the active substance or to an excipient of the study treatments.\n* Have severe vomiting, diarrhea, or other severe gastrointestinal illness within 24 hours prior to the first dose of study treatment that would preclude administration of oral medication.\n* Require mechanical ventilation or vasopressors for hemodynamic support at the time of randomization.\n* Be female and pregnant or nursing.\n* Have previously completed, discontinued, or have been withdrawn from this study.\n* Have received any investigational agent with known anti-CMV activity within 30 days before initiation of study treatment or CMV vaccine at any time.\n* Have received any unapproved agent or device within 30 days before initiation of study treatment.\n* Have any clinically significant medical or surgical condition that, in the investigator's opinion, could interfere with interpretation of study results, contraindicate the administration of the assigned study treatment, or compromise the safety or well-being of the participant.\n* Have previously received maribavir.\n* Have serum aspartate aminotransferase (AST) greater than (\\>) 5 times upper limit of normal (ULN) at screening, or serum alanine aminotransferase (ALT) \\>5 times ULN at screening, or total bilirubin \\>= 3.0\\*ULN at screening (except for documented Gilbert's syndrome), as analyzed by local or central laboratory.\n* Have known (previously documented) positive results for human immunodeficiency virus (HIV). Participants must have a confirmed negative HIV test result within 3 months of study entry or, if unavailable, be tested by a local laboratory during the screening period.\n* Have active malignancy with the exception of nonmelanoma skin cancer, as determined by the investigator. Participants who experience relapse or progression of their underlying malignancy (for which HSCT was performed), as determined by the investigator, are not to be enrolled.\n* Be undergoing treatment for acute or chronic hepatitis C"}, 'identificationModule': {'nctId': 'NCT02927067', 'briefTitle': 'A Study of Maribavir Compared to Valganciclovir to Treat Cytomegalovirus Infections in People Who Have Received Stem Cell Transplants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'A Phase 3, Multicenter, Randomized, Double-blind, Double-dummy, Active-controlled Study to Assess the Efficacy and Safety of Maribavir Compared to Valganciclovir for the Treatment of Cytomegalovirus (CMV) Infection in Hematopoietic Stem Cell Transplant Recipients', 'orgStudyIdInfo': {'id': 'SHP620-302'}, 'secondaryIdInfos': [{'id': '2015-004726-34', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Valganciclovir 900 mg BID', 'description': 'Participants received 900 milligrams (mg) of valganciclovir along with a placebo matched to maribavir, twice daily (BID) orally for 8 weeks. Valganciclovir dose was allowed to be adjusted to 450 mg BID or 450 mg QD based on renal function impairment assessed at baseline or development of neutropenia during the study.', 'interventionNames': ['Drug: Valganciclovir', 'Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Maribavir 400 mg BID', 'description': 'Participants received 400 mg of maribavir along with a placebo matched to valganciclovir, BID orally for 8 weeks.', 'interventionNames': ['Drug: Maribavir', 'Other: Placebo']}], 'interventions': [{'name': 'Maribavir', 'type': 'DRUG', 'description': 'Participants will receive 400 mg of maribavir BID orally.', 'armGroupLabels': ['Maribavir 400 mg BID']}, {'name': 'Valganciclovir', 'type': 'DRUG', 'description': 'Participants will receive valganciclovir tablets orally.', 'armGroupLabels': ['Valganciclovir 900 mg BID']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Participants will receive placebo tablets matched to either maribavir or valganciclovir.', 'armGroupLabels': ['Maribavir 400 mg BID', 'Valganciclovir 900 mg BID']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Colorado Blood Cancer Institute - PPDS', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '06520', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University School of Medicine', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60153', 'city': 'Maywood', 'state': 'Illinois', 'country': 'United States', 'facility': 'Loyola University Medical Center', 'geoPoint': {'lat': 41.8792, 'lon': -87.84312}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland School of Medicine', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Brigham and Womens Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '01655', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'UMass Memorial Medical Center', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Harper University Hospital', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Health System', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '55454', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '59905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic - PIN', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '07601', 'city': 'Hackensack', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Hackensack University Medical Center', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Joan and sandford I. Weill Medical College of Cornell University Clinic', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '37203-1624', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'TriStar Centennial Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '78704', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Saint Davids South Austin Medical Center', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Transplant Institute', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '98108', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'VA Puget Sound Health Care System - NAVREF - PPDS', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'The Medical College of Wisconsin, Inc.', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': '2145', 'city': 'Westmead', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Westmead Hospital', 'geoPoint': {'lat': -33.80383, 'lon': 150.98768}}, {'zip': '5000', 'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Royal Adelaide Hospital', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'zip': '3050', 'city': 'Parkville', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Royal Melbourne Hospital', 'geoPoint': {'lat': -37.78333, 'lon': 144.95}}, {'city': 'Vienna', 'state': 'Vienna', 'country': 'Austria', 'facility': 'Medizinische Universitat Wien (Medical University of Vienna)', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '4020', 'city': 'Linz', 'country': 'Austria', 'facility': 'Elisabethinen Hospital Linz', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'zip': '2650', 'city': 'Edegem', 'state': 'Antwerpen', 'country': 'Belgium', 'facility': 'UZ Antwerpen', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}, {'zip': '1000', 'city': 'Brussels', 'state': 'Brussels Capital', 'country': 'Belgium', 'facility': 'Institute Jules Bordet', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '1200', 'city': 'Brussels', 'state': 'Brussels Capital', 'country': 'Belgium', 'facility': 'Cliniques Universitaires Saint-Luc', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '1090', 'city': 'Jette', 'state': 'Brussels Capital', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Brussel - PIN', 'geoPoint': {'lat': 50.87309, 'lon': 4.33419}}, {'zip': '9000', 'city': 'Ghent', 'state': 'Oost-Vlaanderen', 'country': 'Belgium', 'facility': 'University Hospital Gent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '3000', 'city': 'Leuven', 'state': 'Vlaams Brabant', 'country': 'Belgium', 'facility': 'UZ Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '8000', 'city': 'Bruges', 'state': 'West-Vlaanderen', 'country': 'Belgium', 'facility': 'AZ Sint-Jan AV', 'geoPoint': {'lat': 51.20892, 'lon': 3.22424}}, {'zip': '4000', 'city': 'Liège', 'country': 'Belgium', 'facility': 'CHU de Liège', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'zip': 'V5Z 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'facility': 'Nanfang Hospital Southern Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '215006', 'city': 'Suzhou', 'state': 'Jiangsu', 'country': 'China', 'facility': 'The First Affiliated Hospital of Soochow University', 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}, {'zip': '410008', 'city': 'Changsha', 'country': 'China', 'facility': 'Xiangya Hospital Central South University', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'zip': '510180', 'city': 'Guangzhou', 'country': 'China', 'facility': "Guangzhou First People's Hospital", 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '310003', 'city': 'Hangzhou Zhejiang', 'country': 'China', 'facility': 'The First Affiliated Hospital, College of Medicine, Zhejiang University'}, {'zip': '450008', 'city': 'Zhengzhou', 'country': 'China', 'facility': 'Henan Cancer Hospital', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'zip': '10000', 'city': 'Zagreb', 'country': 'Croatia', 'facility': 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