Viewing Study NCT04140266

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Ignite Creation Date: 2025-12-24 @ 4:21 PM
Ignite Modification Date: 2026-02-24 @ 2:06 PM
Study NCT ID: NCT04140266
Status: COMPLETED
Last Update Posted: 2023-08-04
First Post: 2019-10-24
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Safety and Drug Detection Study of Dapivirine Vaginal Ring and Oral TRUVADA® in Breastfeeding Mother-Infant Pairs
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-05-06', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C481671', 'term': 'Dapivirine'}, {'id': 'D003274', 'term': 'Contraceptive Devices, Female'}, {'id': 'D000069480', 'term': 'Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination'}], 'ancestors': [{'id': 'D003273', 'term': 'Contraceptive Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D000068698', 'term': 'Tenofovir'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000068679', 'term': 'Emtricitabine'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000225', 'term': 'Adenine'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jbalkus@uw.edu', 'phone': '260 616 6614', 'title': 'Jen Balkus', 'organization': 'Hans Rosling Center for Population Health'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'The participant is followed for adverse events during study follow-up which was scheduled to be up to 14 weeks (98 days).', 'description': 'The "Any Event in SOC" rows summarize the total number of adverse events within an SOC. In addition, these events are summarized using the specific Adverse Event Term for the event.', 'eventGroups': [{'id': 'EG000', 'title': 'Mothers - Group A: Dapivirine (DPV) Vaginal Ring (VR)-004', 'description': 'Adverse Events for Mothers randomized to the DPV VR study arm.', 'otherNumAtRisk': 148, 'deathsNumAtRisk': 148, 'otherNumAffected': 92, 'seriousNumAtRisk': 148, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Mothers - Group B: Truvada Tablet', 'description': 'Adverse Events for Mothers randomized to the Truvada oral tablet study arm.', 'otherNumAtRisk': 49, 'deathsNumAtRisk': 49, 'otherNumAffected': 35, 'seriousNumAtRisk': 49, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Infants - Group A: DPV VR', 'description': 'Adverse Events for Infants of Mothers randomized to the DPV VR study arm.', 'otherNumAtRisk': 148, 'deathsNumAtRisk': 148, 'otherNumAffected': 112, 'seriousNumAtRisk': 148, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG003', 'title': 'Infants - Group B: Truvada Tablet', 'description': 'Adverse Events for Infants of Mothers randomized to the Truvada oral tablet study arm.', 'otherNumAtRisk': 49, 'deathsNumAtRisk': 49, 'otherNumAffected': 32, 'seriousNumAtRisk': 49, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Any Event in SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Any Event in SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Micropenis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Any Event in SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Excessive cerumen production', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Amblyopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Any Event in SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Conjunctivitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Eye inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Eye pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pterygium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Any Event in SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 16, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 17, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 16, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Aphthous ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Gingival cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Umbilical hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Any Event in SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Any Event in SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Abscess rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Adenoiditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 1, 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'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Vaginal discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Vaginal odour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Vulvovaginal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Vulvovaginal pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Acute respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Any Event in SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Bronchial hyperreactivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Dry throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Upper-airway cough syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Any Event in SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 28, 'numAffected': 24}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Dermatitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Dermatitis atopic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Dermatitis diaper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Miliaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Rash papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Any Event in SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Phlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}], 'seriousEvents': [{'term': 'Any Event in SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Appendiceal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Dysentery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Any Event in SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Uterine leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 148, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 148, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Mother Participants With Serious Adverse Events (SAEs) Including Maternal Deaths in Both Study Arms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mothers - Group A: Dapivirine (DPV) Vaginal Ring (VR)-004', 'description': 'Adverse Events for Mothers randomized to the DPV VR study arm.'}, {'id': 'OG001', 'title': 'Mothers - Group B: Truvada Tablet', 'description': 'Adverse Events for Mothers randomized to the Truvada oral tablet study arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Measured through Month 3.5', 'description': 'As defined by the Manual for Expedited Reporting of Adverse Events to the Division of AIDS (DAIDS) (Version 2.0, January 2010)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Mothers received study product and are used in the analysis population.'}, {'type': 'PRIMARY', 'title': 'Number of Mother Participants With Grade 3 or Higher Adverse Events (AEs) in Both Study Arms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A: Dapivirine (DPV) Vaginal Ring (VR)-004', 'description': 'Mothers will use one DPV VR continuously for approximately one month, replacing the DPV VR each month for approximately three months.\n\nDapivirine (DPV) Vaginal Ring (VR)-004: Vaginal ring containing 25 mg of DPV'}, {'id': 'OG001', 'title': 'Group B: Truvada Tablet', 'description': 'Mothers will take one Truvada oral tablet daily for approximately three months.\n\nTruvada Tablet: Oral tablet containing 200 mg emtricitabine (FTC)/300 mg tenofovir disoproxil fumarate (TDF)'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Measured through Month 3.5', 'description': 'As defined by the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 and/or Addendum 1 (Female Genital Grading Table for Use in Microbicide Studies \\[Dated November 2007\\])', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled mothers received study product.'}, {'type': 'PRIMARY', 'title': 'Number of Infant Participants With SAEs Including Infant Deaths in Both Study Arms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Infants - Group A: DPV VR', 'description': 'Adverse Events for Infants of Mothers randomized to the DPV VR study arm.'}, {'id': 'OG001', 'title': 'Infants - Group B: Truvada Tablet', 'description': 'Adverse Events for Infants of Mothers randomized to the Truvada oral tablet study arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Measured through Month 3.5', 'description': 'As defined by the Manual for Expedited Reporting of Adverse Events to DAIDS (Version 2.0, January 2010)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "All infants were exposed to study product through mothers' breastmilk. All enrolled mothers received study product."}, {'type': 'PRIMARY', 'title': 'Number of Infant Participants With Grade 3 or Higher AEs in Both Study Arms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Infants - Group A: DPV VR', 'description': 'Adverse Events for Infants of Mothers randomized to the DPV VR study arm.'}, {'id': 'OG001', 'title': 'Infants - Group B: Truvada Tablet', 'description': 'Adverse Events for Infants of Mothers randomized to the Truvada oral tablet study arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Measured through Month 3.5', 'description': 'As defined by the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Infants were exposed to study product through breastmilk. All enrolled mothers received study product.'}, {'type': 'PRIMARY', 'title': 'Number and Proportion of Mothers With Detectable Plasma Dapivirine (DPV) Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mothers - Group A: Dapivirine (DPV) Vaginal Ring (VR)-004', 'description': 'Mothers randomized to the DPV Vaginal Ring study arm with evaluable plasma specimens.'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '139', 'groupId': 'OG000'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '136', 'groupId': 'OG000'}]}]}, {'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '139', 'groupId': 'OG000'}]}]}, {'title': 'Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '138', 'groupId': 'OG000'}]}]}, {'title': 'Product Use End Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '136', 'groupId': 'OG000'}]}]}, {'title': 'Study End Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Measured through Month 3.5', 'description': 'This endpoint is based on DPV concentration laboratory results from evaluable plasma specimens from mother participants. DPV concentrations above the lower limit of quantification (LLOQ) are considered detectable. For DPV concentration in plasma, the LLOQ is 20 pg/ml. The infant endpoint is included as a separate section below.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This endpoint includes the mothers randomized to the DPV VR arm with available and evaluable plasma specimens at the specific timepoint. The "Overall Number of Participants Analyzed" includes mothers with an evaluable specimen for at least one timepoint. Evaluable is defined as the specimens that were successfully tested at the central laboratory. Infant results are in a separate section below.'}, {'type': 'PRIMARY', 'title': 'Number and Proportion of Mothers With Detectable Emtricitabine Triphosphate (FTC-TP) Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mothers - Group B: Truvada Tablet', 'description': 'Mothers randomized to the Truvada oral tablet study arm with evaluable Dried Blood Spot specimens,'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}]}]}, {'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}]}]}, {'title': 'Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}]}]}, {'title': 'Product Use End Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}]}]}, {'title': 'Study End Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Measured through Month 3.5', 'description': 'This endpoint is based on FTC-TP concentration laboratory results from evaluable dried blood spot (DBS) specimens from mother participants. FTC-TP concentrations above the lower limit of quantification (LLOQ) are considered detectable. For FTC-TP concentration in DBS specimens, the LLOQ is 0.125 pmol/punch. The infant endpoint is included as a separate section below.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This endpoint includes the mothers randomized to the Truvada arm with available and evaluable DBS specimens at the specific timepoint. The "Overall Number of Participants Analyzed" includes mothers with an evaluable specimen for at least one timepoint. Evaluable is defined as the specimens that were successfully tested at the central laboratory. Infant results are in a separate section below.'}, {'type': 'PRIMARY', 'title': 'Number and Proportion of Mothers With Detectable Tenofovir Diphosphate (TFV-DP) Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mothers - Group B: Truvada Tablet', 'description': 'Mothers randomized to the Truvada oral tablet study arm with evaluable Dried Blood Spot specimens,'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}]}]}, {'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}]}]}, {'title': 'Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}]}]}, {'title': 'Product Use End Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}]}]}, {'title': 'Study End Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Measured through Month 3.5', 'description': 'This endpoint is based on TFV-DP concentration laboratory results from evaluable dried blood spot (DBS) specimens from mother participants. TFV-DP concentrations above the lower limit of quantification (LLOQ) are considered detectable. For TFV-DP concentrations, the LLOQ is 31.3 fmol/punch. The infant endpoint is included as a separate section below.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This endpoint includes the mothers randomized to the Truvada arm with available and evaluable DBS specimens at the specific timepoint. The "Overall Number of Participants Analyzed" includes mothers with an evaluable specimen for at least one timepoint. Evaluable is defined as the specimens that were successfully tested at the central laboratory. Infant results are in a separate section below.'}, {'type': 'PRIMARY', 'title': 'Number and Proportion of Mothers With Detectable Breastmilk DPV Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mothers - Group A: Dapivirine (DPV) Vaginal Ring (VR)-004', 'description': 'Mothers randomized to the DPV Vaginal Ring study arm with evaluable breast milk specimens.'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '137', 'groupId': 'OG000'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '137', 'groupId': 'OG000'}]}]}, {'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '138', 'groupId': 'OG000'}]}]}, {'title': 'Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '138', 'groupId': 'OG000'}]}]}, {'title': 'Product Use End Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '135', 'groupId': 'OG000'}]}]}, {'title': 'Study End Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Measured through Month 3.5', 'description': 'This endpoint is based on DPV concentration laboratory results from evaluable breastmilk specimens from mother participants. DPV concentrations above the lower limit of quantification (LLOQ) are considered detectable. For DPV concentration in breastmilk, the LLOQ is 10 pg/ml.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This endpoint includes the mothers randomized to the DPV VR arm with available and evaluable breastmilk specimens at the specific timepoint. The "Overall Number of Participants Analyzed" includes mothers with an evaluable specimen for at least one timepoint. Evaluable is defined as the specimens that were successfully tested at the central laboratory. Infants are not included in this population.'}, {'type': 'PRIMARY', 'title': 'Number and Proportion of Mothers With Detectable Breastmilk FTC Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mothers - Group B: Truvada Tablet', 'description': 'Mothers randomized to the Truvada oral tablet study arm with evaluable breast milk specimens,'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}]}]}, {'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}]}]}, {'title': 'Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}]}]}, {'title': 'Product Use End Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}]}]}, {'title': 'Study End Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Measured through Month 3.5', 'description': 'This endpoint is based on FTC concentration laboratory results from evaluable breastmilk specimens from mother participants. FTC concentrations above the lower limit of quantification (LLOQ) are considered detectable. For FTC concentrations in breastmilk, the LLOQ is 5 mg/ml.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This endpoint includes the mothers randomized to the Truvada arm with available and evaluable breastmilk specimens at the specific timepoint. The "Overall Number of Participants Analyzed" includes mothers with an evaluable specimen for at least one timepoint. Evaluable is defined as the specimens that were successfully tested at the central laboratory. Infants are not included in this population.'}, {'type': 'PRIMARY', 'title': 'Number and Proportion of Mothers With Detectable Breastmilk TFV Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mothers - Group B: Truvada Tablet', 'description': 'Mothers randomized to the Truvada oral tablet study arm with evaluable breast milk specimens,'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}]}]}, {'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}]}]}, {'title': 'Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}]}]}, {'title': 'Product Use End Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}]}]}, {'title': 'Study End Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Measured through Month 3.5', 'description': 'This endpoint is based on TFV concentration laboratory results from evaluable breastmilk specimens from mother participants. TFV concentrations above the lower limit of quantification (LLOQ) are considered detectable. For TFV concentrations in breastmilk, the LLOQ is 1 ng/ml.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This endpoint includes the mothers randomized to the Truvada arm with available and evaluable breastmilk specimens at the specific timepoint. The "Overall Number of Participants Analyzed" includes mothers with an evaluable specimen for at least one timepoint. Evaluable is defined as the specimens that were successfully tested at the central laboratory. Infants are not included in this population.'}, {'type': 'PRIMARY', 'title': 'Number and Proportion of Infants With Detectable Plasma DPV Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Infants - Group A: DPV VR', 'description': 'Infants of Mothers randomized to the DPV VR study arm.'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}, {'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}, {'title': 'Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Product Use End Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Study Exit Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Measured through Month 3.5', 'description': 'This endpoint is based on DPV concentration laboratory results from evaluable plasma specimens from infant participants. DPV concentrations above the lower limit of quantification (LLOQ) are considered detectable. For DPV concentration in plasma, the LLOQ is 20 pg/ml. The mother endpoints are included as separate sections above.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This endpoint includes the infants of mothers randomized to the DPV VR arm with available and evaluable plasma specimens at the specific timepoint. The "Overall Number of Participants Analyzed" includes infants with an evaluable specimen for at least one timepoint. Evaluable is defined as the specimens that were successfully tested at the central laboratory. Mother results are in a separate section above.'}, {'type': 'PRIMARY', 'title': 'Number and Proportion of Infants With Detectable FTC-TP Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Infants - Group B: Truvada Tablet', 'description': 'Infants of Mothers randomized to the Truvada oral tablet study arm.'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Product Use End Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Study Exit Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Measured through Month 3.5', 'description': 'This endpoint is based on FTC-TP concentration laboratory results from evaluable dried blood spot (DBS) specimens from infant participants. FTC-TP concentrations above the lower limit of quantification (LLOQ) are considered detectable. For FTC-TP concentrations from DBS specimens, the LLOQ is 0.125 pmol/punch. The mother endpoints are included as separate sections above.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This endpoint includes the infants of mothers randomized to the Truvada arm with available and evaluable DBS specimens at the specific timepoint. The "Overall Number of Participants Analyzed" includes infants with an evaluable specimen for at least one timepoint. Evaluable is defined as the specimens that were successfully tested at the central laboratory. Mother results are in a separate section above.'}, {'type': 'PRIMARY', 'title': 'Number and Proportion of Infants With Detectable TFV-DP Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Infants - Group B: Truvada Tablet', 'description': 'Infants of Mothers randomized to the Truvada oral tablet study arm.'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Product Use End Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Study Exit Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Measured through Month 3.5', 'description': 'This endpoint is based on TFV-DP concentration laboratory results from evaluable dried blood spot (DBS) specimens from infant participants. TFV-DP concentrations above the lower limit of quantification (LLOQ) are considered detectable. For TFV-DP concentrations from DBS specimens, the LLOQ is 31.3 fmol/punch. The mother endpoints are included as separate sections above.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This endpoint includes the infants of mothers randomized to the Truvada arm with available and evaluable DBS specimens at the specific timepoint. The "Overall Number of Participants Analyzed" includes infants with an evaluable specimen for at least one timepoint. Evaluable is defined as the specimens that were successfully tested at the central laboratory. Mother results are in a separate section above.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean of Maternal DPV Concentrations From Plasma by Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mothers - Group A: Dapivirine (DPV) Vaginal Ring (VR)-004', 'description': 'Mothers randomized to the DPV Vaginal Ring study arm with evaluable plasma specimens.'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '327.9', 'spread': '61.3', 'groupId': 'OG000'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '314.9', 'spread': '92.1', 'groupId': 'OG000'}]}]}, {'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '275.4', 'spread': '76.9', 'groupId': 'OG000'}]}]}, {'title': 'Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '263.8', 'spread': '111.9', 'groupId': 'OG000'}]}]}, {'title': 'Product Use End Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '260.4', 'spread': '87.3', 'groupId': 'OG000'}]}]}, {'title': 'Study End Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16.7', 'spread': '93.5', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Measured through Month 3.5', 'description': 'This endpoint is based on DPV concentration laboratory results from evaluable plasma specimens from mother participants. The geometric mean is summarized by study visit and includes only mothers randomized to the DPV VR arm. A value of 1/2 of the LLOQ is used if the concentration falls below the LLOQ (20pg/ml). The infant endpoints for geometric mean concentrations are included as separate sections below.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'This endpoint includes the mothers randomized to the DPV VR arm with available and evaluable plasma specimens at the specific timepoint. The "Overall Number of Participants Analyzed" includes mothers with an evaluable specimen for at least one timepoint. Evaluable is defined as the specimens that were successfully tested at the central laboratory. Infant results are in a separate section below.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean of Maternal FTC-TP Concentrations by Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mothers - Group B: Truvada Tablet', 'description': 'Mothers randomized to the Truvada oral tablet study arm with evaluable Dried Blood Spot specimens,'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '51.3', 'groupId': 'OG000'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '58.4', 'groupId': 'OG000'}]}]}, {'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '91.5', 'groupId': 'OG000'}]}]}, {'title': 'Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '90.9', 'groupId': 'OG000'}]}]}, {'title': 'Product Use End Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '91.3', 'groupId': 'OG000'}]}]}, {'title': 'Study End Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '21.9', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Measured through Month 3.5', 'description': 'This endpoint is based on FTC-TP concentration laboratory results from evaluable dried blood spot (DBS) specimens from mother participants. The geometric mean is summarized by study visit and includes only mothers randomized to the Truvada arm. A value of 1/2 of the LLOQ is used if the concentration falls below the LLOQ (0.125 pmol/punch). The infant endpoints for geometric mean concentrations are included as separate sections below.', 'unitOfMeasure': 'pmol/punch', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'This endpoint includes the mothers randomized to the Truvada arm with available and evaluable DBS specimens at the specific timepoint. The "Overall Number of Participants Analyzed" includes mothers with an evaluable specimen for at least one timepoint. Evaluable is defined as the specimens that were successfully tested at the central laboratory. Infant results are in a separate section below.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean of Maternal TFV-DP Concentrations by Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mothers - Group B: Truvada Tablet', 'description': 'Mothers randomized to the Truvada oral tablet study arm with evaluable Dried Blood Spot specimens,'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '254.6', 'spread': '62.8', 'groupId': 'OG000'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '424.2', 'spread': '65.2', 'groupId': 'OG000'}]}]}, {'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '524.7', 'spread': '117.8', 'groupId': 'OG000'}]}]}, {'title': 'Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '551.9', 'spread': '97.5', 'groupId': 'OG000'}]}]}, {'title': 'Product Use End Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '591.5', 'spread': '135.5', 'groupId': 'OG000'}]}]}, {'title': 'Study End Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '330.8', 'spread': '137.8', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Measured through Month 3.5', 'description': 'This endpoint is based on TFV-DP concentration laboratory results from evaluable dried blood spot (DBS) specimens from mother participants. The geometric mean is summarized by study visit and includes only mothers randomized to the Truvada arm. A value of 1/2 of the LLOQ is used if the concentration falls below the LLOQ (31.3 fmol/punch). The infant endpoints for geometric mean concentrations are included as separate sections below.', 'unitOfMeasure': 'fmol/punch', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'This endpoint includes the mothers randomized to the Truvada arm with available and evaluable DBS specimens at the specific timepoint. The "Overall Number of Participants Analyzed" includes mothers with an evaluable specimen for at least one timepoint. Evaluable is defined as the specimens that were successfully tested at the central laboratory. Infant results are in a separate section below.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean of Maternal DPV Concentrations From Breastmilk by Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mothers - Group A: Dapivirine (DPV) Vaginal Ring (VR)-004', 'description': 'Mothers randomized to the DPV Vaginal Ring study arm with evaluable breast milk specimens.'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '529.4', 'spread': '108.0', 'groupId': 'OG000'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '492.0', 'spread': '122.3', 'groupId': 'OG000'}]}]}, {'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '457.0', 'spread': '119.3', 'groupId': 'OG000'}]}]}, {'title': 'Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '418.9', 'spread': '545.0', 'groupId': 'OG000'}]}]}, {'title': 'Product Use End Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '402.8', 'spread': '154.5', 'groupId': 'OG000'}]}]}, {'title': 'Study End Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '20.0', 'spread': '210.7', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Measured through Month 3.5', 'description': 'This endpoint is based on DPV concentration laboratory results from evaluable breastmilk specimens from mother participants. The geometric mean is summarized by study visit and includes only mothers randomized to the DPV VR arm. A value of 1/2 of the LLOQ is used if the concentration falls below the LLOQ (10pg/ml). The infant endpoints for geometric mean concentrations are included as separate sections below.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'This endpoint includes the mothers randomized to the DPV VR arm with available and evaluable breastmilk specimens at the specific timepoint. The "Overall Number of Participants Analyzed" includes mothers with an evaluable specimen for at least one timepoint. Evaluable is defined as the specimens that were successfully tested at the central laboratory. Infant results are in a separate section below.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean of Maternal FTC Concentrations From Breastmilk by Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mothers - Group B: Truvada Tablet', 'description': 'Mothers randomized to the Truvada oral tablet study arm with evaluable breast milk specimens,'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '552.6', 'spread': '167.4', 'groupId': 'OG000'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '447.6', 'spread': '329.0', 'groupId': 'OG000'}]}]}, {'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '319.9', 'spread': '453.8', 'groupId': 'OG000'}]}]}, {'title': 'Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '313.0', 'spread': '707.9', 'groupId': 'OG000'}]}]}, {'title': 'Product Use End Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '296.6', 'spread': '1099.2', 'groupId': 'OG000'}]}]}, {'title': 'Study End Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.8', 'spread': '88.9', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Measured through Month 3.5', 'description': 'This endpoint is based on FTC concentration laboratory results from evaluable breastmilk specimens from mother participants. The geometric mean is summarized by study visit and includes only mothers randomized to the Truvada arm. A value of 1/2 of the LLOQ is used if the concentration falls below the LLOQ (5 mg/ml). The infant endpoints for geometric mean concentrations are included as separate sections below.', 'unitOfMeasure': 'mg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'This endpoint includes the mothers randomized to the Truvada arm with available and evaluable breastmilk specimens at the specific timepoint. The "Overall Number of Participants Analyzed" includes mothers with an evaluable specimen for at least one timepoint. Evaluable is defined as the specimens that were successfully tested at the central laboratory. Infant results are in a separate section below.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean of Maternal TFV Concentrations From Breastmilk by Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mothers - Group B: Truvada Tablet', 'description': 'Mothers randomized to the Truvada oral tablet study arm with evaluable breast milk specimens,'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.6', 'spread': '72.3', 'groupId': 'OG000'}]}]}, {'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.3', 'spread': '89.5', 'groupId': 'OG000'}]}]}, {'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.3', 'spread': '108.3', 'groupId': 'OG000'}]}]}, {'title': 'Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.2', 'spread': '120.0', 'groupId': 'OG000'}]}]}, {'title': 'Product Use End Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.7', 'spread': '107.2', 'groupId': 'OG000'}]}]}, {'title': 'Study End Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '106.5', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Measured through Month 3.5', 'description': 'This endpoint is based on TFV concentration laboratory results from evaluable breastmilk specimens from mother participants. The geometric mean is summarized by study visit and includes only mothers randomized to the Truvada arm. A value of 1/2 of the LLOQ is used if the concentration falls below the LLOQ (1 ng/ml). The infant endpoints for geometric mean concentrations are included as separate sections below.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'This endpoint includes the mothers randomized to the Truvada arm with available and evaluable breastmilk specimens at the specific timepoint. The "Overall Number of Participants Analyzed" includes mothers with an evaluable specimen for at least one timepoint. Evaluable is defined as the specimens that were successfully tested at the central laboratory. Infant results are in a separate section below.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean of Infant DPV Concentrations From Plasma by Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Infants - Group A: DPV VR', 'description': 'Infants of Mothers randomized to the DPV VR study arm.'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.7', 'spread': '46.3', 'groupId': 'OG000'}]}]}, {'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.5', 'spread': '35.7', 'groupId': 'OG000'}]}]}, {'title': 'Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.0', 'spread': '31.7', 'groupId': 'OG000'}]}]}, {'title': 'Product Use End Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '138', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.5', 'spread': '19.8', 'groupId': 'OG000'}]}]}, {'title': 'Study End Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10', 'spread': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Measured through Month 3.5', 'description': 'This endpoint is based on DPV concentration laboratory results from evaluable plasma specimens from infant participants. The geometric mean is summarized by study visit and includes only infants of mothers randomized to the DPV VR arm. A value of 1/2 of the LLOQ is used if the concentration falls below the LLOQ (20pg/ml). The mother endpoints for geometric mean concentrations are included as separate sections above.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'This endpoint includes the infants of mothers randomized to the DPV VR arm with available and evaluable plasma specimens at the specific timepoint. The "Overall Number of Participants Analyzed" includes infants with an evaluable specimen for at least one timepoint. Evaluable is defined as the specimens that were successfully tested at the central laboratory. Mother results are in a separate section above.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean of Infant FTC-TP Concentration by Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Infants - Group B: Truvada Tablet', 'description': 'Infants of Mothers randomized to the Truvada oral tablet study arm.'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '23.5', 'groupId': 'OG000'}]}]}, {'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '16.3', 'groupId': 'OG000'}]}]}, {'title': 'Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '15.4', 'groupId': 'OG000'}]}]}, {'title': 'Product Use End Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '12.1', 'groupId': 'OG000'}]}]}, {'title': 'Study End Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Measured through Month 3.5', 'description': 'This endpoint is based on FTC-TP concentration laboratory results from evaluable dried blood spot (DBS) specimens from infant participants. The geometric mean is summarized by study visit and includes only infants of mothers randomized to the Truvada arm. A value of 1/2 of the LLOQ is used if the concentration falls below the LLOQ (0.125 pmol/punch). The mother endpoints for geometric mean concentrations are included as separate sections above.', 'unitOfMeasure': 'pmol/punch', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'This endpoint includes the infants of mothers randomized to the Truvada arm with available and evaluable DBS specimens at the specific timepoint. The "Overall Number of Participants Analyzed" includes infants with an evaluable specimen for at least one timepoint. Evaluable is defined as the specimens that were successfully tested at the central laboratory. Mother results are in a separate section above.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean of Infant TFV-DP Concentrations by Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Infants - Group B: Truvada Tablet', 'description': 'Infants of Mothers randomized to the Truvada oral tablet study arm.'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15.6', 'spread': '0', 'groupId': 'OG000'}]}]}, {'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15.6', 'spread': '0', 'groupId': 'OG000'}]}]}, {'title': 'Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15.6', 'spread': '0', 'groupId': 'OG000'}]}]}, {'title': 'Product Use End Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15.6', 'spread': '0', 'groupId': 'OG000'}]}]}, {'title': 'Study End Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15.6', 'spread': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Measured through Month 3.5', 'description': 'This endpoint is based on TFV-DP concentration laboratory results from evaluable dried blood spot (DBS) specimens from infant participants. The geometric mean is summarized by study visit and includes only infants of mothers randomized to the Truvada arm. A value of 1/2 of the LLOQ is used if the concentration falls below the LLOQ (31.3 fmol/punch). The mother endpoints for geometric mean concentrations are included as separate sections above.', 'unitOfMeasure': 'fmol/punch', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'This endpoint includes the infants of mothers randomized to the Truvada arm with available and evaluable DBS specimens at the specific timepoint. The "Overall Number of Participants Analyzed" includes infants with an evaluable specimen for at least one timepoint. Evaluable is defined as the specimens that were successfully tested at the central laboratory. Mother results are in a separate section above.'}, {'type': 'SECONDARY', 'title': 'The Number of Mothers Non-adherent to Study Product for Each Month of Product Use by Study Product', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mothers - Group A: Dapivirine (DPV) Vaginal Ring (VR)-004', 'description': 'Non-adherence of Mothers randomized to the DPV VR study arm.'}, {'id': 'OG001', 'title': 'Mothers - Group B: Truvada Tablet', 'description': 'Non-adherence of Mothers randomized to the Truvada oral tablet study arm.'}], 'classes': [{'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Measured through Month 3', 'description': "The number and proportion of mother's visits with drug concentration indicative of non-adherence (no use) are reported by study month. Non-adherence is measured by residual drug in returned VRs for mothers assigned the DPV VR arm and by TFV-DP concentrations in dried blood spot specimens for mothers assigned the Truvada tablet arm. For mothers on the DPV VR arm, no use is defined as residual DPV concentration in the returned VRs \\<= 0.9mg/month. For mothers on the Truvada arm, no use is defined as TFV-DP concentrations \\< 16.6 fmol/punch. Only mother participants are included in this endpoint since infants did not directly use study product in this study.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only mother participants are included in this endpoint since infants did not directly use study product. The number of mothers analyzed includes mother participants with a returned/used vaginal ring that was successfully analyzed for residual drug concentration (evaluable) for Group A (DPV VR) and only those participants with an available and evaluable dried blood plot specimen for mothers in Group B (Truvada). Rings returned after the Month 3 Product Use End Visit (PUEV) are excluded.'}, {'type': 'SECONDARY', 'title': 'Residual Drug Levels in Returned VRs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Mothers - Group A: Dapivirine (DPV) Vaginal Ring (VR)-004', 'description': 'Mothers randomized to the DPV Vaginal Ring study arm with evaluable results for residual DPV concentrations from returned VRs.'}], 'classes': [{'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '22.1', 'groupId': 'OG000', 'lowerLimit': '21.4', 'upperLimit': '22.8'}]}]}, {'title': 'Month 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '22.4', 'groupId': 'OG000', 'lowerLimit': '21.5', 'upperLimit': '23.3'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '22.1', 'groupId': 'OG000', 'lowerLimit': '21.3', 'upperLimit': '23.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Measured through Month 3.5', 'description': 'The residual DPV concentrations from the returned VRs are summarized.', 'unitOfMeasure': 'mg', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population includes mothers with evaluable residual DPV concentrations from returned vaginal rings (VRs). Rings returned on or after the Month 3 visit are included in the Month 3 summary.'}, {'type': 'SECONDARY', 'title': 'Participant Willingness to Use Their Assigned Study Products During Breastfeeding in the Future (Y/N)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mothers - Group A: Dapivirine (DPV) Vaginal Ring (VR)-004', 'description': 'Mothers randomized to the Dapivirine (DPV) monthly Vaginal Ring (VR) study arm.'}, {'id': 'OG001', 'title': 'Mothers - Group B: Truvada Tablet', 'description': 'Mothers randomized to the Truvada oral tablet study arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '142', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Measured through Month 3.5', 'description': 'Based on participant report to the question "Would you be willing to use the study product for HIV prevention while breastfeeding in the future?"', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of mothers analyzed includes all mothers who completed the Product End Use Visit Behavioral Assessment and responded to the willingness question. The count of participants who are willing, responded "Yes" to the question.'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants Who Find Their Study Product to be at Least as Acceptable as Other HIV Prevention Methods', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mothers - Group A: Dapivirine (DPV) Vaginal Ring (VR)-004', 'description': 'Mothers randomized to the Dapivirine (DPV) monthly Vaginal Ring (VR) study arm.'}, {'id': 'OG001', 'title': 'Mothers - Group B: Truvada Tablet', 'description': 'Mothers randomized to the Truvada oral tablet study arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '141', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Measured through Month 3.5', 'description': 'Based on participant report on the question "Overall, how much did you like using the study product?" on the Product End Use Visit Behavioral Assessment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of mothers analyzed included those who completed the Product End Use Visit Behavioral Assessment and responded to the acceptability question. The mothers who answered "Like very much" or "Like" are included in the total who find the study product acceptable.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group A: Dapivirine (DPV) Vaginal Ring (VR)-004', 'description': 'Mothers will use one DPV VR continuously for approximately one month, replacing the DPV VR each month for approximately three months.\n\nDapivirine (DPV) Vaginal Ring (VR)-004: Vaginal ring containing 25 mg of DPV'}, {'id': 'FG001', 'title': 'Group B: Truvada Tablet', 'description': 'Mothers will take one Truvada oral tablet daily for approximately three months.\n\nTruvada Tablet: Oral tablet containing 200 mg emtricitabine (FTC)/300 mg tenofovir disoproxil fumarate (TDF)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Mothers and infants are added as two milestones.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '296'}, {'groupId': 'FG001', 'numSubjects': '98'}]}, {'type': 'Mothers', 'achievements': [{'groupId': 'FG000', 'numSubjects': '148'}, {'groupId': 'FG001', 'numSubjects': '49'}]}, {'type': 'Infants', 'achievements': [{'groupId': 'FG000', 'numSubjects': '148'}, {'groupId': 'FG001', 'numSubjects': '49'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '290'}, {'groupId': 'FG001', 'numSubjects': '96'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': '197 mother-infant pairs were enrolled in 4 African countries from September 2020 until July 2021.', 'preAssignmentDetails': '197 mother-infant pairs were enrolled in the study. When the mothers are enrolled and discontinued from the study, their infants are enrolled or discontinued.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}, {'value': '394', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Mothers - Group A: Dapivirine (DPV) Vaginal Ring (VR)-004', 'description': 'Adverse Events for Mothers randomized to the DPV VR study arm.'}, {'id': 'BG001', 'title': 'Mothers - Group B: Truvada Tablet', 'description': 'Adverse Events for Mothers randomized to the Truvada oral tablet study arm.'}, {'id': 'BG002', 'title': 'Infants - Group A: DPV VR', 'description': 'Adverse Events for Infants of Mothers randomized to the DPV VR study arm.'}, {'id': 'BG003', 'title': 'Infants - Group B: Truvada Tablet', 'description': 'Adverse Events for Infants of Mothers randomized to the Truvada oral tablet study arm.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': "Mothers' Age, years", 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '197', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '43'}, {'value': '25', 'groupId': 'BG001', 'lowerLimit': '18', 'upperLimit': '38'}, {'value': '26', 'groupId': 'BG004', 'lowerLimit': '18', 'upperLimit': '43'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'Only mothers are included in this baseline measure since mother age is summarized in years. Infants age is summarized below in weeks.'}, {'title': 'Age, Continuous', 'classes': [{'title': "Infants' Age, weeks", 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}, {'value': '197', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG002', 'lowerLimit': '6', 'upperLimit': '12'}, {'value': '8', 'groupId': 'BG003', 'lowerLimit': '6', 'upperLimit': '12'}, {'value': '9', 'groupId': 'BG004', 'lowerLimit': '6', 'upperLimit': '12'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'weeks', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'Only infants are included in this baseline measure since infant age is summarized in weeks.'}, {'title': 'Age, Customized', 'classes': [{'title': 'mother age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '197', 'groupId': 'BG004'}]}], 'categories': [{'title': '18-19 years', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}]}, {'title': '20-24 years', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '67', 'groupId': 'BG004'}]}, {'title': '25-29 years', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '54', 'groupId': 'BG004'}]}, {'title': '30-34 years', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '40', 'groupId': 'BG004'}]}, {'title': '35-39 years', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}]}, {'title': '40-45 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Only mothers are included in this baseline measure since mothers age is in years. Infants are categorized below in weeks.'}, {'title': 'Age, Customized', 'classes': [{'title': 'Infant age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}, {'value': '197', 'groupId': 'BG004'}]}], 'categories': [{'title': '6 to 9 weeks', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}, {'value': '121', 'groupId': 'BG004'}]}, {'title': '>9 weeks to 12 weeks', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '76', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Only infants are included in this baseline measure since infant age is categorized in weeks.'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}, {'value': '394', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '148', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '305', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '89', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}, {'value': '394', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '148', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}, {'value': '394', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}, {'value': '394', 'groupId': 'BG004'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '148', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}, {'value': '394', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Malawi', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}, {'value': '394', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '78', 'groupId': 'BG004'}]}]}, {'title': 'South Africa', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}, {'value': '394', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '72', 'groupId': 'BG004'}]}]}, {'title': 'Uganda', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}, {'value': '394', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '110', 'groupId': 'BG004'}]}]}, {'title': 'Zimbabwe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}, {'value': '394', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '134', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-07-24', 'size': 18082625, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-04-07T11:59', 'hasProtocol': True}, {'date': '2022-11-04', 'size': 405783, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-04-06T01:39', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 394}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2021-11-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-14', 'studyFirstSubmitDate': '2019-10-24', 'resultsFirstSubmitDate': '2023-04-10', 'studyFirstSubmitQcDate': '2019-10-24', 'lastUpdatePostDateStruct': {'date': '2023-08-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-07-14', 'studyFirstPostDateStruct': {'date': '2019-10-25', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-08-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Mother Participants With Serious Adverse Events (SAEs) Including Maternal Deaths in Both Study Arms', 'timeFrame': 'Measured through Month 3.5', 'description': 'As defined by the Manual for Expedited Reporting of Adverse Events to the Division of AIDS (DAIDS) (Version 2.0, January 2010)'}, {'measure': 'Number of Mother Participants With Grade 3 or Higher Adverse Events (AEs) in Both Study Arms', 'timeFrame': 'Measured through Month 3.5', 'description': 'As defined by the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 and/or Addendum 1 (Female Genital Grading Table for Use in Microbicide Studies \\[Dated November 2007\\])'}, {'measure': 'Number of Infant Participants With SAEs Including Infant Deaths in Both Study Arms', 'timeFrame': 'Measured through Month 3.5', 'description': 'As defined by the Manual for Expedited Reporting of Adverse Events to DAIDS (Version 2.0, January 2010)'}, {'measure': 'Number of Infant Participants With Grade 3 or Higher AEs in Both Study Arms', 'timeFrame': 'Measured through Month 3.5', 'description': 'As defined by the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017'}, {'measure': 'Number and Proportion of Mothers With Detectable Plasma Dapivirine (DPV) Concentrations', 'timeFrame': 'Measured through Month 3.5', 'description': 'This endpoint is based on DPV concentration laboratory results from evaluable plasma specimens from mother participants. DPV concentrations above the lower limit of quantification (LLOQ) are considered detectable. For DPV concentration in plasma, the LLOQ is 20 pg/ml. The infant endpoint is included as a separate section below.'}, {'measure': 'Number and Proportion of Mothers With Detectable Emtricitabine Triphosphate (FTC-TP) Concentrations', 'timeFrame': 'Measured through Month 3.5', 'description': 'This endpoint is based on FTC-TP concentration laboratory results from evaluable dried blood spot (DBS) specimens from mother participants. FTC-TP concentrations above the lower limit of quantification (LLOQ) are considered detectable. For FTC-TP concentration in DBS specimens, the LLOQ is 0.125 pmol/punch. The infant endpoint is included as a separate section below.'}, {'measure': 'Number and Proportion of Mothers With Detectable Tenofovir Diphosphate (TFV-DP) Concentrations', 'timeFrame': 'Measured through Month 3.5', 'description': 'This endpoint is based on TFV-DP concentration laboratory results from evaluable dried blood spot (DBS) specimens from mother participants. TFV-DP concentrations above the lower limit of quantification (LLOQ) are considered detectable. For TFV-DP concentrations, the LLOQ is 31.3 fmol/punch. The infant endpoint is included as a separate section below.'}, {'measure': 'Number and Proportion of Mothers With Detectable Breastmilk DPV Concentrations', 'timeFrame': 'Measured through Month 3.5', 'description': 'This endpoint is based on DPV concentration laboratory results from evaluable breastmilk specimens from mother participants. DPV concentrations above the lower limit of quantification (LLOQ) are considered detectable. For DPV concentration in breastmilk, the LLOQ is 10 pg/ml.'}, {'measure': 'Number and Proportion of Mothers With Detectable Breastmilk FTC Concentrations', 'timeFrame': 'Measured through Month 3.5', 'description': 'This endpoint is based on FTC concentration laboratory results from evaluable breastmilk specimens from mother participants. FTC concentrations above the lower limit of quantification (LLOQ) are considered detectable. For FTC concentrations in breastmilk, the LLOQ is 5 mg/ml.'}, {'measure': 'Number and Proportion of Mothers With Detectable Breastmilk TFV Concentrations', 'timeFrame': 'Measured through Month 3.5', 'description': 'This endpoint is based on TFV concentration laboratory results from evaluable breastmilk specimens from mother participants. TFV concentrations above the lower limit of quantification (LLOQ) are considered detectable. For TFV concentrations in breastmilk, the LLOQ is 1 ng/ml.'}, {'measure': 'Number and Proportion of Infants With Detectable Plasma DPV Concentrations', 'timeFrame': 'Measured through Month 3.5', 'description': 'This endpoint is based on DPV concentration laboratory results from evaluable plasma specimens from infant participants. DPV concentrations above the lower limit of quantification (LLOQ) are considered detectable. For DPV concentration in plasma, the LLOQ is 20 pg/ml. The mother endpoints are included as separate sections above.'}, {'measure': 'Number and Proportion of Infants With Detectable FTC-TP Concentrations', 'timeFrame': 'Measured through Month 3.5', 'description': 'This endpoint is based on FTC-TP concentration laboratory results from evaluable dried blood spot (DBS) specimens from infant participants. FTC-TP concentrations above the lower limit of quantification (LLOQ) are considered detectable. For FTC-TP concentrations from DBS specimens, the LLOQ is 0.125 pmol/punch. The mother endpoints are included as separate sections above.'}, {'measure': 'Number and Proportion of Infants With Detectable TFV-DP Concentrations', 'timeFrame': 'Measured through Month 3.5', 'description': 'This endpoint is based on TFV-DP concentration laboratory results from evaluable dried blood spot (DBS) specimens from infant participants. TFV-DP concentrations above the lower limit of quantification (LLOQ) are considered detectable. For TFV-DP concentrations from DBS specimens, the LLOQ is 31.3 fmol/punch. The mother endpoints are included as separate sections above.'}, {'measure': 'Geometric Mean of Maternal DPV Concentrations From Plasma by Visit', 'timeFrame': 'Measured through Month 3.5', 'description': 'This endpoint is based on DPV concentration laboratory results from evaluable plasma specimens from mother participants. The geometric mean is summarized by study visit and includes only mothers randomized to the DPV VR arm. A value of 1/2 of the LLOQ is used if the concentration falls below the LLOQ (20pg/ml). The infant endpoints for geometric mean concentrations are included as separate sections below.'}, {'measure': 'Geometric Mean of Maternal FTC-TP Concentrations by Visit', 'timeFrame': 'Measured through Month 3.5', 'description': 'This endpoint is based on FTC-TP concentration laboratory results from evaluable dried blood spot (DBS) specimens from mother participants. The geometric mean is summarized by study visit and includes only mothers randomized to the Truvada arm. A value of 1/2 of the LLOQ is used if the concentration falls below the LLOQ (0.125 pmol/punch). The infant endpoints for geometric mean concentrations are included as separate sections below.'}, {'measure': 'Geometric Mean of Maternal TFV-DP Concentrations by Visit', 'timeFrame': 'Measured through Month 3.5', 'description': 'This endpoint is based on TFV-DP concentration laboratory results from evaluable dried blood spot (DBS) specimens from mother participants. The geometric mean is summarized by study visit and includes only mothers randomized to the Truvada arm. A value of 1/2 of the LLOQ is used if the concentration falls below the LLOQ (31.3 fmol/punch). The infant endpoints for geometric mean concentrations are included as separate sections below.'}, {'measure': 'Geometric Mean of Maternal DPV Concentrations From Breastmilk by Visit', 'timeFrame': 'Measured through Month 3.5', 'description': 'This endpoint is based on DPV concentration laboratory results from evaluable breastmilk specimens from mother participants. The geometric mean is summarized by study visit and includes only mothers randomized to the DPV VR arm. A value of 1/2 of the LLOQ is used if the concentration falls below the LLOQ (10pg/ml). The infant endpoints for geometric mean concentrations are included as separate sections below.'}, {'measure': 'Geometric Mean of Maternal FTC Concentrations From Breastmilk by Visit', 'timeFrame': 'Measured through Month 3.5', 'description': 'This endpoint is based on FTC concentration laboratory results from evaluable breastmilk specimens from mother participants. The geometric mean is summarized by study visit and includes only mothers randomized to the Truvada arm. A value of 1/2 of the LLOQ is used if the concentration falls below the LLOQ (5 mg/ml). The infant endpoints for geometric mean concentrations are included as separate sections below.'}, {'measure': 'Geometric Mean of Maternal TFV Concentrations From Breastmilk by Visit', 'timeFrame': 'Measured through Month 3.5', 'description': 'This endpoint is based on TFV concentration laboratory results from evaluable breastmilk specimens from mother participants. The geometric mean is summarized by study visit and includes only mothers randomized to the Truvada arm. A value of 1/2 of the LLOQ is used if the concentration falls below the LLOQ (1 ng/ml). The infant endpoints for geometric mean concentrations are included as separate sections below.'}, {'measure': 'Geometric Mean of Infant DPV Concentrations From Plasma by Visit', 'timeFrame': 'Measured through Month 3.5', 'description': 'This endpoint is based on DPV concentration laboratory results from evaluable plasma specimens from infant participants. The geometric mean is summarized by study visit and includes only infants of mothers randomized to the DPV VR arm. A value of 1/2 of the LLOQ is used if the concentration falls below the LLOQ (20pg/ml). The mother endpoints for geometric mean concentrations are included as separate sections above.'}, {'measure': 'Geometric Mean of Infant FTC-TP Concentration by Visit', 'timeFrame': 'Measured through Month 3.5', 'description': 'This endpoint is based on FTC-TP concentration laboratory results from evaluable dried blood spot (DBS) specimens from infant participants. The geometric mean is summarized by study visit and includes only infants of mothers randomized to the Truvada arm. A value of 1/2 of the LLOQ is used if the concentration falls below the LLOQ (0.125 pmol/punch). The mother endpoints for geometric mean concentrations are included as separate sections above.'}, {'measure': 'Geometric Mean of Infant TFV-DP Concentrations by Visit', 'timeFrame': 'Measured through Month 3.5', 'description': 'This endpoint is based on TFV-DP concentration laboratory results from evaluable dried blood spot (DBS) specimens from infant participants. The geometric mean is summarized by study visit and includes only infants of mothers randomized to the Truvada arm. A value of 1/2 of the LLOQ is used if the concentration falls below the LLOQ (31.3 fmol/punch). The mother endpoints for geometric mean concentrations are included as separate sections above.'}], 'secondaryOutcomes': [{'measure': 'The Number of Mothers Non-adherent to Study Product for Each Month of Product Use by Study Product', 'timeFrame': 'Measured through Month 3', 'description': "The number and proportion of mother's visits with drug concentration indicative of non-adherence (no use) are reported by study month. Non-adherence is measured by residual drug in returned VRs for mothers assigned the DPV VR arm and by TFV-DP concentrations in dried blood spot specimens for mothers assigned the Truvada tablet arm. For mothers on the DPV VR arm, no use is defined as residual DPV concentration in the returned VRs \\<= 0.9mg/month. For mothers on the Truvada arm, no use is defined as TFV-DP concentrations \\< 16.6 fmol/punch. Only mother participants are included in this endpoint since infants did not directly use study product in this study."}, {'measure': 'Residual Drug Levels in Returned VRs', 'timeFrame': 'Measured through Month 3.5', 'description': 'The residual DPV concentrations from the returned VRs are summarized.'}, {'measure': 'Participant Willingness to Use Their Assigned Study Products During Breastfeeding in the Future (Y/N)', 'timeFrame': 'Measured through Month 3.5', 'description': 'Based on participant report to the question "Would you be willing to use the study product for HIV prevention while breastfeeding in the future?"'}, {'measure': 'Proportion of Participants Who Find Their Study Product to be at Least as Acceptable as Other HIV Prevention Methods', 'timeFrame': 'Measured through Month 3.5', 'description': 'Based on participant report on the question "Overall, how much did you like using the study product?" on the Product End Use Visit Behavioral Assessment.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HIV Infections']}, 'referencesModule': {'references': [{'pmid': '39954697', 'type': 'DERIVED', 'citation': 'Noguchi LM, Owor M, Mgodi NM, Gati Mirembe B, Dadabhai S, Horne E, Gundacker H, Richardson BA, Bunge K, Scheckter R, Song M, Marzinke MA, Anderson PL, Livant E, Jacobson C, Piper JM, Chakhtoura N, Hillier SL, Balkus JE; MTN-043 Study Team. Safety and drug quantification of the dapivirine vaginal ring and oral pre-exposure prophylaxis in breastfeeding mother-infant pairs (MTN-043): a phase 3B, open-label, randomised trial. Lancet HIV. 2025 Mar;12(3):e180-e190. doi: 10.1016/S2352-3018(24)00306-0. Epub 2025 Feb 12.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and drug detection of the dapivirine vaginal ring and oral Truvada in breastfeeding mother-infant pairs.', 'detailedDescription': 'This study will evaluate the safety and drug detection of the dapivirine (DPV) vaginal ring (VR) and oral Truvada in breastfeeding mother-infant pairs.\n\nMother-infant pairs will be randomly assigned to receive either the DPV VR or oral Truvada. Mothers randomized to the DPV VR will use the VR continuously for approximately one month (4 weeks), replacing the VR each month for approximately three months (12 weeks). Mothers using the Truvada tablet will take one tablet by mouth daily for approximately three months (12 weeks).\n\nStudy visits will occur at Day 0, Weeks 1 and 2, and Months 1, 2, 3, and 3.5. Study visits may include behavioral assessments; product acceptability assessments; infant feeding assessments; physical examinations; blood, urine, and breast milk collection; and pelvic examination and specimen collection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Weeks', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nInclusion Criteria - Mother\n\nParticipant mothers must meet all the following criteria to be eligible for inclusion in the study:\n\n* Age 18 years or older at Screening, as verified per site Standard Operating Procedures (SOPs).\n* At Enrollment, between 6 to 12 weeks postpartum (verified by birth records and/or similar supportive documentation and defined as between 42 - 84 days after delivery, inclusive).\n* By participant report at Screening and Enrollment, currently exclusively breastfeeding one infant and willing and able to continue exclusively breastfeeding that infant for the duration of their participation in the study.\n\n * Note: Exclusive breastfeeding will be defined as infant nutrition solely from breast milk, as determined by 7-day recall breastfeeding history. For the purposes of MTN-043, "breastfeeding" refers to all human milk feeding situations when an infant is fed with participant\'s own human milk whether the milk is received directly from the breast or as expressed milk.\n* Consistently using an effective method of contraception per participant report at Enrollment, and intending to continue use of an effective method for the duration of study participation. Effective methods include contraceptive implants, intrauterine device, injectable progestin, oral contraceptive pills, and surgical sterilization.\n* Able and willing to comply with all study requirements and complete all study procedures.\n* Able and willing to provide the following:\n\n * Written informed consent to be screened for and to take part in the study.\n * Written informed consent for the breastfed infant to be screened for and take part in the study.\n* Intention to stay within study catchment area for study duration and willingness to give adequate locator information, as defined in site SOPs.\n* At Screening and Enrollment, HIV-uninfected based on HIV testing performed by study staff (per algorithm in the study protocol).\n* At Screening and Enrollment, willing to be randomized at time of enrollment to either of the study products, and to continue study product use for at least 12 weeks.\n\nInclusion Criteria - Infant\n\nEach mother eligible for MTN-043 will be asked to provide written informed consent for herself and her infant to participate in the study if the infant meets the following criteria:\n\n* At Screening and Enrollment, infant is exclusively breastfed.\n\n * Note: Exclusive breastfeeding will be defined as infant nutrition solely from breast milk, as determined by 7-day recall breastfeeding history. For the purposes of MTN-043, "breastfeeding" refers to all human milk feeding situations when an infant is fed with participant\'s own human milk whether the milk is received directly from the breast or as expressed milk.\n* At Screening and Enrollment, the infant is generally healthy, according to the judgment of the investigator of record (IoR)/designee.\n* At Enrollment, the infant is between the ages of 6 and 12 weeks postpartum (verified by birth records and/or similar supportive documentation with age defined as between 42 - 84 days after delivery, inclusive).\n\nExclusion Criteria:\n\nExclusion Criteria - Mother\n\nMothers who meet any of the following criteria will be excluded from the study:\n\n* At Screening or Enrollment, breastfeeding infant ineligible for enrollment in the study.\n* At Screening or Enrollment, participant reports any of the following:\n\n * Known adverse reaction to any of the study products (ever).\n * Known adverse reaction to latex and polyurethane (ever).\n * Post-exposure prophylaxis (PEP) for HIV exposure within 6 months prior to Enrollment.\n * Use of vaginal medications(s) or other vaginal products within five days prior to Enrollment.\n * Non-therapeutic injection drug use in the 12 months prior to Enrollment.\n * History of exposure to any investigational drug(s) during pregnancy, including participation in MTN-042.\n* At Screening or Enrollment, has a positive HIV test.\n* At Screening or Enrollment, Grade 2 or higher breast or genitourinary findings.\n* At Screening or Enrollment, has a positive urinary pregnancy test.\n* At Screening, has any of the following laboratory abnormalities:\n\n * Positive for hepatitis B surface antigen (HBsAg).\n * Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≥ Grade 2.\n * Creatinine ≥ Grade 1.\n * Estimated creatinine clearance ≥ Grade 2 (Cockcroft Gault formula).\n* Diagnosed with urinary tract infection (UTI), pelvic inflammatory disease (PID), sexually transmitted infection (STI) or reproductive tract infection (RTI), requiring treatment per World Health Organization (WHO) Guidelines.\n\n * Note: Otherwise eligible participants diagnosed during Screening with a UTI, PID or STI/RTI requiring treatment per WHO Guidelines - other than asymptomatic bacterial vaginosis (BV) and asymptomatic vulvovaginal candidiasis - are offered treatment consistent with WHO recommendations and may be enrolled after completing treatment if all symptoms have resolved. If treatment is completed and symptoms have resolved prior to obtaining informed consent for Screening, the participant may be enrolled. Genital warts requiring treatment also must be treated prior to enrollment. Genital warts requiring treatment are defined as those that cause undue burden or discomfort to the participant, including bulky size, unacceptable appearance, or physical discomfort.\n* As determined by the IoR/designee, any significant uncontrolled active or chronic cardiovascular, renal, liver, hematologic, neurologic, gastrointestinal, psychiatric, endocrine, respiratory, immunologic disorder or infectious disease.\n* Has any other condition that, in the opinion of the IoR/designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.\n* At Enrollment, participant reports any of the following:\n\n * Participation in any research study involving drugs, vaccines, or medical devices 30 days or less prior to enrollment.\n * Currently participating in other research studies involving drugs, vaccines, or medical devices.\n * Expected to participate in other research studies involving drugs, vaccines, or medical devices during study participation.\n\nExclusion Criteria - Infants\n\n* Has any condition that, in the opinion of the IoR/designee, would preclude eligibility, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.\n\n * Note: Examples of exclusionary infant conditions include clinical evidence of stunting or illness.\n* At Enrollment, according to the report of the mother, any of the following apply for the infant:\n\n * Infants with birth weight less than 2000g.\n * Participation in any research study involving drugs, vaccines, or medical devices since birth.\n * Currently participating in other research studies involving drugs, vaccines, or medical devices.\n * Expected to participate in other research studies involving drugs, vaccines, or medical devices for the duration of study participation.'}, 'identificationModule': {'nctId': 'NCT04140266', 'briefTitle': 'Safety and Drug Detection Study of Dapivirine Vaginal Ring and Oral TRUVADA® in Breastfeeding Mother-Infant Pairs', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Allergy and Infectious Diseases (NIAID)'}, 'officialTitle': 'Phase 3B, Randomized, Open-Label, Safety, and Drug Detection Study of Dapivirine Vaginal Ring and Oral TRUVADA® in Breastfeeding Mother-Infant Pairs', 'orgStudyIdInfo': {'id': 'MTN-043'}, 'secondaryIdInfos': [{'id': '38591', 'type': 'REGISTRY', 'domain': 'DAIDS-ES Registry Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A: Dapivirine (DPV) Vaginal Ring (VR)-004', 'description': 'Mothers will use one DPV VR continuously for approximately one month, replacing the DPV VR each month for approximately three months.', 'interventionNames': ['Drug: Dapivirine (DPV) Vaginal Ring (VR)-004']}, {'type': 'EXPERIMENTAL', 'label': 'Group B: Truvada Tablet', 'description': 'Mothers will take one Truvada oral tablet daily for approximately three months.', 'interventionNames': ['Drug: Truvada Tablet']}], 'interventions': [{'name': 'Dapivirine (DPV) Vaginal Ring (VR)-004', 'type': 'DRUG', 'description': 'Vaginal ring containing 25 mg of DPV', 'armGroupLabels': ['Group A: Dapivirine (DPV) Vaginal Ring (VR)-004']}, {'name': 'Truvada Tablet', 'type': 'DRUG', 'otherNames': ['Emtricitabine/Tenofovir Disoproxil Fumarate', 'FTC/TDF'], 'description': 'Oral tablet containing 200 mg emtricitabine (FTC)/300 mg tenofovir disoproxil fumarate (TDF)', 'armGroupLabels': ['Group B: Truvada Tablet']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Blantyre', 'country': 'Malawi', 'facility': 'Blantyre CRS (Johns Hopkins Research Project/College of Medicine)', 'geoPoint': {'lat': -15.78499, 'lon': 35.00854}}, {'zip': '2001', 'city': 'Johannesburg', 'state': 'Gauteng', 'country': 'South Africa', 'facility': 'Wits RHI Shandukani Research Centre CRS', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}, {'city': 'Kampala', 'country': 'Uganda', 'facility': 'MU-JHU Research Collaboration (MUJHU CARE LTD) CRS', 'geoPoint': {'lat': 0.31628, 'lon': 32.58219}}, {'city': 'Chitungwiza', 'state': 'Mashonaland East Province', 'country': 'Zimbabwe', 'facility': 'Zengeza CRS'}], 'overallOfficials': [{'name': 'Maxensia Owor, MBChB, MMed, MPH', 'role': 'STUDY_CHAIR', 'affiliation': 'MU-JHU CARE'}, {'name': 'Lisa Noguchi, PhD, CNM', 'role': 'STUDY_CHAIR', 'affiliation': 'Johns Hopkins Bloomberg School of Public Health'}, {'name': 'Jen Balkus, PhD, MPH', 'role': 'STUDY_CHAIR', 'affiliation': 'Hans Rosling Center for Population Health'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'within 8 weeks of request approval and to be available as long as needed.', 'ipdSharing': 'YES', 'description': 'Individual participant data will be made available to researchers upon request. The IPD to be shared will be negotiated with the researchers', 'accessCriteria': 'MTN-043 study management team approval'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}