Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2025-12-28 @ 5:38 AM
Study NCT ID:
NCT05179057
Status:
TERMINATED
Last Update Posted:
2024-05-08
First Post:
2021-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Posoleucel (ALVR105) for the Treatment of Adenovirus Infection in Pediatric and Adult Participants Receiving Standard of Care Following Allogeneic Hematopoietic Cell Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000257', 'term': 'Adenoviridae Infections'}], 'ancestors': [{'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rriese@allovir.com', 'phone': '+1 617-433-2605', 'title': 'Senior Vice President', 'organization': 'AlloVir, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The study was discontinued following a pre-planned DSMB futility analysis concluding that the study was unlikely to meet its primary endpoint, no safety concerns were identified.'}}, 'adverseEventsModule': {'timeFrame': 'Up to 34 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Posoleucel (Primary Study Period)', 'description': 'Participants were randomized to receive 2 sequential infusions of posoleucel, separated by 14 ± 3 days, during the Primary Study Period.', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 27, 'seriousNumAtRisk': 28, 'deathsNumAffected': 2, 'seriousNumAffected': 16}, {'id': 'EG001', 'title': 'Placebo (Primary Study Period)', 'description': 'Participants were randomized to receive 2 sequential infusions of placebo, separated by 14 ± 3 days, during the Primary Study Period.', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 23, 'seriousNumAtRisk': 23, 'deathsNumAffected': 1, 'seriousNumAffected': 16}, {'id': 'EG002', 'title': 'Posoleucel (Cross-over Period)', 'description': 'Participants were randomized to receive 2 sequential infusions of placebo in the Primary Study Period and were eligible to cross-over between Day 29 and Week 10. Participants received posoleucel during the Cross-over Period.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 5, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG003', 'title': 'Placebo (Cross-over Period)', 'description': 'Participants were randomized to receive 2 sequential infusions of posoleucel in the Primary Study Period and were eligible to cross-over between Day 29 and Week 10. Participants received placebo during the Cross-over Period.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 3, 'seriousNumAtRisk': 4, 'deathsNumAffected': 1, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Rhinovirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'BK virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Candida infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Adenovirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Cytomegalovirus infection reactivation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Cytomegalovirus viraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Gastroenteritis adenovirus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Adenoviral hepatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Enterovirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Epstein-Barr virus infection reactivation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Klebsiella bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Epstein-Barr viraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Klebsiella infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Viral rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Blood bicarbonate decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Activated partial thromboplastin time prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Enterobacter test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Hypervolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Iron overload', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 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'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}, {'term': 'Autoimmune haemolytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Undetectable Adenovirus Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Posoleucel, Then Placebo', 'description': 'Participants were randomized to receive 2 sequential infusions of posoleucel, separated by 14 ± 3 days. The Primary Study Period included a 4-week efficacy evaluation followed by a 20-week safety follow-up.\n\nEligible participants who experienced progression to active target organ disease or progression of existing target organ disease could cross-over to placebo treatment between Day 29 and Week 10. In the Cross-Over Period, participants received 2 sequential infusions of placebo, separated by 14 ± 3 days. The Cross-over Period included a 4-week efficacy evaluation followed by a 20-week safety follow-up.'}, {'id': 'OG001', 'title': 'Placebo, Then Posoleucel', 'description': 'Participants were randomized to receive 2 sequential infusions of placebo, separated by 14 ± 3 days. The Primary Study Period included a 4-week efficacy evaluation followed by a 20-week safety follow-up.\n\nEligible participants who experienced progression to active target organ disease or progression of existing target organ disease could cross-over to posoleucel treatment between Day 29 and Week 10. In the Cross-Over Period, participants received 2 sequential infusions of placebo, separated by 14 ± 3 days. The Cross-over Period included a 4-week efficacy evaluation followed by a 20-week safety follow-up.'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.26', 'ciUpperLimit': '3.69', 'estimateComment': 'Posoleucel versus Placebo', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'A logistic regression model included treatment, level of viremia at baseline (≥10,000 copies/mL or \\<10,000 copies/mL adenovirus DNA), age (≥12 years or \\<12 years), and absolute lymphocyte counts at baseline. The null hypothesis is that the true percentage for posoleucel plus SoC is less than or equal to the true percentage for placebo plus SoC, and the alternative hypothesis is that it is greater.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 29 through Day 43 (Day 29 + 14 days; up to 43 days post-first infusion)', 'description': 'Viral load of adenovirus was measured at the central laboratory using quantitative polymerase chain reaction (qPCR) from blood and stool samples at each study visit and on Day 29 from a nasopharyngeal swab. There was a 14-day window for participants who crossed over from posoleucel to placebo; and for participants who crossed over from placebo to posoleucel, the pre-dose cross-over Day 1 viral load was used. Participants missing the primary endpoint but having undetectable viremia before Day 29 and after Day 43 were imputed as successes. Undetectable adenovirus viremia was less than the lower limit of quantification (LLOQ).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The modified intent-to-treat (mITT) population included all randomized participants who received at least one dose of posoleucel or placebo. Only participants in the mITT population who completed through Day 29 or discontinued early were included.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Posoleucel (Primary Study Period)', 'description': 'Participants were randomized to receive 2 sequential infusions of posoleucel, separated by 14 ± 3 days, during the Primary Study Period.'}, {'id': 'OG001', 'title': 'Placebo (Primary Study Period)', 'description': 'Participants were randomized to receive 2 sequential infusions of placebo, separated by 14 ± 3 days, during the Primary Study Period.'}, {'id': 'OG002', 'title': 'Posoleucel (Cross-over Period)', 'description': 'Participants were randomized to receive 2 sequential infusions of placebo in the Primary Study Period and were eligible to cross-over between Day 29 and Week 10. Participants received posoleucel during the Cross-over Period.'}, {'id': 'OG003', 'title': 'Placebo (Cross-over Period)', 'description': 'Participants were randomized to receive 2 sequential infusions of posoleucel in the Primary Study Period and were eligible to cross-over between Day 29 and Week 10. Participants received placebo during the Cross-over Period.'}], 'classes': [{'title': 'Any TEAE', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Any TEAE related to study treatment', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Any AESI', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Any SAE', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Any SAE related to study treatment', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Any TEAE leading to study treatment discontinuation', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Any TEAE leading to study discontinuation', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Any TEAE leading to death', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 34 weeks', 'description': 'A TEAE was defined as an adverse event (AE) with a start date and time on or after the first dose of study treatment. A serious AE (SAE) was an AE that met at least one of the following serious criteria: fatal, life-threatening, required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect; or other important medical event. TEAEs of special interest (AESI) included acute or chronic graft versus host disease, cytokine release syndrome, infusion-related reactions, and graft failure or rejection. Treatment-related refers to the assessment of a relationship between study treatment and the event by the investigator.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all participants who received any amount of posoleucel or placebo and had at least one post-treatment safety assessment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Overall Disease Progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Posoleucel, Then Placebo', 'description': 'Participants were randomized to receive 2 sequential infusions of posoleucel, separated by 14 ± 3 days. The Primary Study Period included a 4-week efficacy evaluation followed by a 20-week safety follow-up.\n\nEligible participants who experienced progression to active target organ disease or progression of existing target organ disease could cross-over to placebo treatment between Day 29 and Week 10. In the Cross-Over Period, participants received 2 sequential infusions of placebo, separated by 14 ± 3 days. The Cross-over Period included a 4-week efficacy evaluation followed by a 20-week safety follow-up.'}, {'id': 'OG001', 'title': 'Placebo, Then Posoleucel', 'description': 'Participants were randomized to receive 2 sequential infusions of placebo, separated by 14 ± 3 days. The Primary Study Period included a 4-week efficacy evaluation followed by a 20-week safety follow-up.\n\nEligible participants who experienced progression to active target organ disease or progression of existing target organ disease could cross-over to posoleucel treatment between Day 29 and Week 10. In the Cross-Over Period, participants received 2 sequential infusions of placebo, separated by 14 ± 3 days. The Cross-over Period included a 4-week efficacy evaluation followed by a 20-week safety follow-up.'}], 'timeFrame': 'From Day 29 up to Week 10', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected due to early termination after Data and Safety Monitoring Board (DSMB) futility analysis concluded the study was unlikely to meet its primary endpoint.'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve (AUC) Adenovirus Viral Load', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Posoleucel, Then Placebo', 'description': 'Participants were randomized to receive 2 sequential infusions of posoleucel, separated by 14 ± 3 days. The Primary Study Period included a 4-week efficacy evaluation followed by a 20-week safety follow-up.\n\nEligible participants who experienced progression to active target organ disease or progression of existing target organ disease could cross-over to placebo treatment between Day 29 and Week 10. In the Cross-Over Period, participants received 2 sequential infusions of placebo, separated by 14 ± 3 days. The Cross-over Period included a 4-week efficacy evaluation followed by a 20-week safety follow-up.'}, {'id': 'OG001', 'title': 'Placebo, Then Posoleucel', 'description': 'Participants were randomized to receive 2 sequential infusions of placebo, separated by 14 ± 3 days. The Primary Study Period included a 4-week efficacy evaluation followed by a 20-week safety follow-up.\n\nEligible participants who experienced progression to active target organ disease or progression of existing target organ disease could cross-over to posoleucel treatment between Day 29 and Week 10. In the Cross-Over Period, participants received 2 sequential infusions of placebo, separated by 14 ± 3 days. The Cross-over Period included a 4-week efficacy evaluation followed by a 20-week safety follow-up.'}], 'timeFrame': 'Pre-dose and Day 29', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected due to early termination after DSMB futility analysis concluded the study was unlikely to meet its primary endpoint.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Achieved Adenovirus Viremia <400 Copies/mL at Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Posoleucel, Then Placebo', 'description': 'Participants were randomized to receive 2 sequential infusions of posoleucel, separated by 14 ± 3 days. The Primary Study Period included a 4-week efficacy evaluation followed by a 20-week safety follow-up.\n\nEligible participants who experienced progression to active target organ disease or progression of existing target organ disease could cross-over to placebo treatment between Day 29 and Week 10. In the Cross-Over Period, participants received 2 sequential infusions of placebo, separated by 14 ± 3 days. The Cross-over Period included a 4-week efficacy evaluation followed by a 20-week safety follow-up.'}, {'id': 'OG001', 'title': 'Placebo, Then Posoleucel', 'description': 'Participants were randomized to receive 2 sequential infusions of placebo, separated by 14 ± 3 days. The Primary Study Period included a 4-week efficacy evaluation followed by a 20-week safety follow-up.\n\nEligible participants who experienced progression to active target organ disease or progression of existing target organ disease could cross-over to posoleucel treatment between Day 29 and Week 10. In the Cross-Over Period, participants received 2 sequential infusions of placebo, separated by 14 ± 3 days. The Cross-over Period included a 4-week efficacy evaluation followed by a 20-week safety follow-up.'}], 'timeFrame': 'Day 29', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected due to early termination after DSMB futility analysis concluded the study was unlikely to meet its primary endpoint.'}, {'type': 'SECONDARY', 'title': 'Time to Undetectable Adenovirus Viremia (Less Than LLOQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Posoleucel, Then Placebo', 'description': 'Participants were randomized to receive 2 sequential infusions of posoleucel, separated by 14 ± 3 days. The Primary Study Period included a 4-week efficacy evaluation followed by a 20-week safety follow-up.\n\nEligible participants who experienced progression to active target organ disease or progression of existing target organ disease could cross-over to placebo treatment between Day 29 and Week 10. In the Cross-Over Period, participants received 2 sequential infusions of placebo, separated by 14 ± 3 days. The Cross-over Period included a 4-week efficacy evaluation followed by a 20-week safety follow-up.'}, {'id': 'OG001', 'title': 'Placebo, Then Posoleucel', 'description': 'Participants were randomized to receive 2 sequential infusions of placebo, separated by 14 ± 3 days. The Primary Study Period included a 4-week efficacy evaluation followed by a 20-week safety follow-up.\n\nEligible participants who experienced progression to active target organ disease or progression of existing target organ disease could cross-over to posoleucel treatment between Day 29 and Week 10. In the Cross-Over Period, participants received 2 sequential infusions of placebo, separated by 14 ± 3 days. The Cross-over Period included a 4-week efficacy evaluation followed by a 20-week safety follow-up.'}], 'timeFrame': 'Pre-dose to 34 weeks', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected due to early termination after DSMB futility analysis concluded the study was unlikely to meet its primary endpoint.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adenovirus Disease Recurrence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Posoleucel, Then Placebo', 'description': 'Participants were randomized to receive 2 sequential infusions of posoleucel, separated by 14 ± 3 days. The Primary Study Period included a 4-week efficacy evaluation followed by a 20-week safety follow-up.\n\nEligible participants who experienced progression to active target organ disease or progression of existing target organ disease could cross-over to placebo treatment between Day 29 and Week 10. In the Cross-Over Period, participants received 2 sequential infusions of placebo, separated by 14 ± 3 days. The Cross-over Period included a 4-week efficacy evaluation followed by a 20-week safety follow-up.'}, {'id': 'OG001', 'title': 'Placebo, Then Posoleucel', 'description': 'Participants were randomized to receive 2 sequential infusions of placebo, separated by 14 ± 3 days. The Primary Study Period included a 4-week efficacy evaluation followed by a 20-week safety follow-up.\n\nEligible participants who experienced progression to active target organ disease or progression of existing target organ disease could cross-over to posoleucel treatment between Day 29 and Week 10. In the Cross-Over Period, participants received 2 sequential infusions of placebo, separated by 14 ± 3 days. The Cross-over Period included a 4-week efficacy evaluation followed by a 20-week safety follow-up.'}], 'timeFrame': '34 weeks', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected due to early termination after DSMB futility analysis concluded the study was unlikely to meet its primary endpoint.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Posoleucel, Then Placebo', 'description': 'Participants were randomized to receive 2 sequential infusions of posoleucel, separated by 14 ± 3 days. The Primary Study Period included a 4-week efficacy evaluation followed by a 20-week safety follow-up.\n\nEligible participants who experienced progression to active target organ disease or progression of existing target organ disease could cross-over to placebo treatment between Day 29 and Week 10. In the Cross-Over Period, participants received 2 sequential infusions of placebo, separated by 14 ± 3 days. The Cross-over Period included a 4-week efficacy evaluation followed by a 20-week safety follow-up.'}, {'id': 'FG001', 'title': 'Placebo, Then Posoleucel', 'description': 'Participants were randomized to receive 2 sequential infusions of placebo, separated by 14 ± 3 days. The Primary Study Period included a 4-week efficacy evaluation followed by a 20-week safety follow-up.\n\nEligible participants who experienced progression to active target organ disease or progression of existing target organ disease could cross-over to posoleucel treatment between Day 29 and Week 10. In the Cross-Over Period, participants received 2 sequential infusions of placebo, separated by 14 ± 3 days. The Cross-over Period included a 4-week efficacy evaluation followed by a 20-week safety follow-up.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'Received Primary Study Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'Met Cross-over Eligibility Criteria', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Received Cross-over Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '14'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Non-compliance with protocol requirements or study-related procedures', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Study terminated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Discontinuation or withdrawal by participants/parent/legal guardian', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Never received primary or cross-over study treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Participants were enrolled at 47 study centers in the United States, Canada, Italy, Spain, Sweden, and the United Kingdom, and participated from April 2022 to January 2024.', 'preAssignmentDetails': 'Participants with adenovirus infection receiving standard of care following allogeneic hematopoietic stem cell transplant (allo-HCT) were randomized in a 1:1 ratio to receive either posoleucel or placebo. Randomization was stratified by level of viremia (≥10,000 copies/mL or \\<10,000 copies/mL adenovirus DNA) and age (≥12 years or \\<12 years).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Posoleucel, Then Placebo', 'description': 'Participants were randomized to receive 2 sequential infusions of posoleucel, separated by 14 ± 3 days. The Primary Study Period included a 4-week efficacy evaluation followed by a 20-week safety follow-up.\n\nEligible participants who experienced progression to active target organ disease or progression of existing target organ disease could cross-over to placebo treatment between Day 29 and Week 10. In the Cross-Over Period, participants received 2 sequential infusions of placebo, separated by 14 ± 3 days. The Cross-over Period included a 4-week efficacy evaluation followed by a 20-week safety follow-up.'}, {'id': 'BG001', 'title': 'Placebo, Then Posoleucel', 'description': 'Participants were randomized to receive 2 sequential infusions of placebo, separated by 14 ± 3 days. The Primary Study Period included a 4-week efficacy evaluation followed by a 20-week safety follow-up.\n\nEligible participants who experienced progression to active target organ disease or progression of existing target organ disease could cross-over to posoleucel treatment between Day 29 and Week 10. In the Cross-Over Period, participants received 2 sequential infusions of placebo, separated by 14 ± 3 days. The Cross-over Period included a 4-week efficacy evaluation followed by a 20-week safety follow-up.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '16.2', 'spread': '17.10', 'groupId': 'BG000'}, {'value': '14.9', 'spread': '15.80', 'groupId': 'BG001'}, {'value': '15.6', 'spread': '16.36', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}, {'title': 'Not Reported', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-11-30', 'size': 3360998, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-04-12T06:50', 'hasProtocol': True}, {'date': '2024-01-12', 'size': 400610, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-04-12T06:52', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study with option for blinded crossover to assess the safety and efficacy of posoleucel as compared to placebo for the treatment of AdV infection in pediatric and adult recipients of HCT with AdV infections receiving SoC.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}}, 'statusModule': {'whyStopped': 'Study discontinued as DSMB determined it was futile. No safety concerns were noted.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-04-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-15', 'studyFirstSubmitDate': '2021-12-17', 'resultsFirstSubmitDate': '2024-04-15', 'studyFirstSubmitQcDate': '2022-01-04', 'lastUpdatePostDateStruct': {'date': '2024-05-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-04-15', 'studyFirstPostDateStruct': {'date': '2022-01-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Undetectable Adenovirus Infection', 'timeFrame': 'Day 29 through Day 43 (Day 29 + 14 days; up to 43 days post-first infusion)', 'description': 'Viral load of adenovirus was measured at the central laboratory using quantitative polymerase chain reaction (qPCR) from blood and stool samples at each study visit and on Day 29 from a nasopharyngeal swab. There was a 14-day window for participants who crossed over from posoleucel to placebo; and for participants who crossed over from placebo to posoleucel, the pre-dose cross-over Day 1 viral load was used. Participants missing the primary endpoint but having undetectable viremia before Day 29 and after Day 43 were imputed as successes. Undetectable adenovirus viremia was less than the lower limit of quantification (LLOQ).'}, {'measure': 'Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)', 'timeFrame': 'Up to 34 weeks', 'description': 'A TEAE was defined as an adverse event (AE) with a start date and time on or after the first dose of study treatment. A serious AE (SAE) was an AE that met at least one of the following serious criteria: fatal, life-threatening, required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect; or other important medical event. TEAEs of special interest (AESI) included acute or chronic graft versus host disease, cytokine release syndrome, infusion-related reactions, and graft failure or rejection. Treatment-related refers to the assessment of a relationship between study treatment and the event by the investigator.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Overall Disease Progression', 'timeFrame': 'From Day 29 up to Week 10'}, {'measure': 'Area Under the Curve (AUC) Adenovirus Viral Load', 'timeFrame': 'Pre-dose and Day 29'}, {'measure': 'Number of Participants Who Achieved Adenovirus Viremia <400 Copies/mL at Day 29', 'timeFrame': 'Day 29'}, {'measure': 'Time to Undetectable Adenovirus Viremia (Less Than LLOQ)', 'timeFrame': 'Pre-dose to 34 weeks'}, {'measure': 'Number of Participants With Adenovirus Disease Recurrence', 'timeFrame': '34 weeks'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Allogeneic Hematopoietic Cell Transplant', 'Adenoviremia', 'Adenovirus', 'Stem Cell Transplant', 'Posoleucel', 'ALVR105', 'Bone Marrow Transplant'], 'conditions': ['Adenovirus Infection']}, 'referencesModule': {'references': [{'pmid': '38597860', 'type': 'DERIVED', 'citation': 'Vasileiou S, Kuvalekar M, Velazquez Y, Watanabe A, Leen AM, Gilmore SA. Phenotypic and functional characterization of posoleucel, a multivirus-specific T cell therapy for the treatment and prevention of viral infections in immunocompromised patients. Cytotherapy. 2024 Aug;26(8):869-877. doi: 10.1016/j.jcyt.2024.03.012. Epub 2024 Mar 19.'}]}, 'descriptionModule': {'briefSummary': 'This study will assess the safety and efficacy of Posoleucel for the treatment of adenovirus (AdV) infection in pediatric and adult allo-HCT recipients receiving standard of care (SoC).', 'detailedDescription': 'During the period of immune recovery after allogeneic hematopoietic cell transplant (allo-HCT), viral infections and reactivations, including those with AdV, are an important cause of morbidity and mortality. Progression to AdV disease is associated with significant morbidity and mortality rates. This Phase 3, multicenter, randomized, double-blind, placebo-controlled study will assess the safety and efficacy of Posoleucel for the treatment of AdV infection in pediatric and adult allo-HCT recipients receiving SoC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Undergone allogeneic cell transplantation ≥21 days prior to dosing\n* Meet one of the below criteria:\n\n 1. AdV viremia DNA ≥10,000 copies/mL, OR\n 2. AdV viremia DNA results of ≥1,000 copies/mL, AND\n\n 1. has absolute lymphocyte count \\<180/mm3, OR\n 2. has received T cell depletion OR\n 3. had a cord blood transplant.\n\nExclusion Criteria:\n\n* Grade 3 or higher acute GVHD\n* Ongoing therapy with high-dose systemic corticosteroids\n* Uncontrolled viral (other than AdV), bacterial, or fungal infection(s)\n* Pregnant or lactating female unwilling to discontinue nursing prior to randomization\n* History of severe prior reactions to blood product transfusions\n\nNOTE: Other protocol-defined inclusion/exclusion criterion may apply.'}, 'identificationModule': {'nctId': 'NCT05179057', 'briefTitle': 'Posoleucel (ALVR105) for the Treatment of Adenovirus Infection in Pediatric and Adult Participants Receiving Standard of Care Following Allogeneic Hematopoietic Cell Transplantation', 'organization': {'class': 'INDUSTRY', 'fullName': 'AlloVir'}, 'officialTitle': 'Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial, With Cross-Over, of Posoleucel (ALVR105) for the Treatment of Adenovirus Infection in Pediatric and Adult Participants Receiving Standard of Care Following Allogeneic Hematopoietic Cell Transplantation', 'orgStudyIdInfo': {'id': 'P-105-303'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Posoleucel + SoC', 'description': 'Posoleucel + SOC; then placebo + SOC for patients who meet optional protocol-defined crossover criteria', 'interventionNames': ['Drug: Posoleucel']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo + SoC', 'description': 'Placebo + SOC; then Posoleucel + SOC for patients who meet optional protocol-defined crossover criteria', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Posoleucel', 'type': 'DRUG', 'description': 'Administered as 2-4 milliliter infusion, visually identical to placebo', 'armGroupLabels': ['Posoleucel + SoC']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered as 2-4 milliliter infusion, visually identical to Posoleucel', 'armGroupLabels': ['Placebo + SoC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85234', 'city': 'Gilbert', 'state': 'Arizona', 'country': 'United States', 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 33.35283, 'lon': -111.78903}}, {'zip': '85016', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': "Phoenix Children's Hospital", 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Los Angeles (UCLA)', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94303', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': "Lucile Packard Children's Hospital - Stanford University", 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': "University of California, San Diego - Rady Children's Hospital", 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': "Children's Hospital Colorado - Center for Cancer and Blood Disorders", 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': "Children's National Medical Center", 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '32611', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida (UF) - Gainesville', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "Ann and Robert H. Lurie Children's Hospital of Chicago", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana-Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine in St. Louis', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '07601', 'city': 'Hackensack', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Hackensack University Medical Center', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York Presbyterian Hospital', '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': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'University of Oklahoma', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Southwestern', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': "Cook Children's Medical Center", 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '81432', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': "Intermountain HealthCare - Primary Children's Hospital", 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '98101', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': "Seattle Children's Hospital", 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': 'M5G 1X8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Hospital for Sick Children (SickKids)', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H3T 1C5', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'CHU Sainte-Justine', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': '20132', 'city': 'Milan', 'country': 'Italy', 'facility': 'IRCCS Ospedale San Raffaele', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '20900', 'city': 'Monza', 'country': 'Italy', 'facility': 'Fondazione IRCCS San Gerardo dei Tintori', 'geoPoint': {'lat': 45.58005, 'lon': 9.27246}}, {'zip': '80123', 'city': 'Napoli', 'country': 'Italy', 'facility': 'A.O.R.N. Santobono-Pausilipon', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'zip': '35128', 'city': 'Padua', 'country': 'Italy', 'facility': 'Azienda Ospedaliera di Padova', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'zip': '27100', 'city': 'Pavia', 'country': 'Italy', 'facility': 'Fondazione IRCCS Policlinico San Matteo', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}, {'zip': '165', 'city': 'Roma', 'country': 'Italy', 'facility': 'Ospedale Pediatrico Bambino Gesù', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '10126', 'city': 'Torino', 'country': 'Italy', 'facility': 'Ospedale Regina Margherita', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'zip': '1-37126', 'city': 'Verona', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Universitaria Integrata Verona-Ospedale Borgo Trento', 'geoPoint': {'lat': 45.43854, 'lon': 10.9938}}, {'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': "Hospital Universitario Vall d'Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28046', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario La Paz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '46026', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Universitari i Politecnic La Fe', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '41685', 'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Sahlgrenska University Hospital', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'zip': '221 85', 'city': 'Lund', 'country': 'Sweden', 'facility': 'Skane University Hospital Lund', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}, {'zip': '171 64', 'city': 'Solna', 'country': 'Sweden', 'facility': 'Karolinska University Hospital', 'geoPoint': {'lat': 59.36004, 'lon': 18.00086}}, {'zip': 'B4 6NH', 'city': 'Birmingham', 'country': 'United Kingdom', 'facility': "Birmingham Children's Hospital", 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'BS2 8BJ', 'city': 'Bristol', 'country': 'United Kingdom', 'facility': 'Bristol Royal Hospital for Children', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}, {'zip': 'G51 4TF', 'city': 'Glasgow', 'country': 'United Kingdom', 'facility': 'Royal Hospital for Children - Glasgow', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'zip': 'NW1 2PG', 'city': 'London', 'country': 'United Kingdom', 'facility': 'University College London Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'W2 1NY', 'city': 'London', 'country': 'United Kingdom', 'facility': "St. Mary's Hospital, Paddington", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'WC1n 3JH', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Great Ormond Street Hospital for Children', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'M13 9WL', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': "Royal Manchester Children's Hospital", 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'zip': 'S10 2TH', 'city': 'Sheffield', 'country': 'United Kingdom', 'facility': "Sheffield Children's NHS Foundation Trust", 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AlloVir', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}