Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-25 @ 9:55 PM
Study NCT ID:
NCT00799058
Status:
COMPLETED
Last Update Posted:
2022-10-25
First Post:
2008-11-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Safety Study of Two Dapivirine (TMC120) Vaginal Gels in the United States
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C481671', 'term': 'Dapivirine'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jsteytler@ipmglobal.org', 'title': 'Dr John Steytler', 'organization': 'International Partnership for Microbicides'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Concluding a general trend in vaginal fluid data is, however, difficult as overall individual fluid levels for the two gel formulations were in the same range and differences based on median values were not consistent across visits.'}}, 'adverseEventsModule': {'timeFrame': 'Trial duration: 18 months The maximum period of gel exposure in all three treatment groups was 12 weeks.', 'eventGroups': [{'id': 'EG000', 'title': 'Dapivirine Gel 4759', 'description': 'Will be applied by participants once daily for12-weeks treatment period\n\ndapivirine gel 4759: dapivirine gel 4759, 0.05%, 2.5g applied once daily', 'otherNumAtRisk': 43, 'deathsNumAtRisk': 43, 'otherNumAffected': 30, 'seriousNumAtRisk': 43, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Dapivirine Gel 4789', 'description': 'will be applied by participants once daily for 12-weeks treatment period\n\ndapivirine 4789: dapivirine gel 4789, 0.05%, 2.5g applied once daily', 'otherNumAtRisk': 43, 'deathsNumAtRisk': 43, 'otherNumAffected': 34, 'seriousNumAtRisk': 43, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'HEC-based Placebo Gel, 2.5g Containing no Dapivirine', 'description': 'Will be applied once daily for 12-weeks treatment period\n\nDrug placebo: HEC-based universal placebo gel, 2.5g applied once daily', 'otherNumAtRisk': 42, 'deathsNumAtRisk': 42, 'otherNumAffected': 35, 'seriousNumAtRisk': 42, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Abdominal Pain Lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Chlamydial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Gonorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Vaginal candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Vaginitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Vulvovaginal myotic infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Adnexa uteri pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Cervix erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Dysmenorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Dyspareunia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Menorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Metrorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Vaginal discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Vulvovaginal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Vulvovaginal pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Pharyngolaryngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'seriousEvents': [{'term': 'Cellulitis of the left breast', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 42, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'frequencyThreshold': '4'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Percentage of Women With the Composite Endpoint of Abnormal Safety Findings.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dapivirine Gel 4759', 'description': 'Will be applied by participants once daily for12-weeks treatment period\n\ndapivirine gel 4759: dapivirine gel 4759, 0.05%, 2.5g applied once daily'}, {'id': 'OG001', 'title': 'Dapivirine Gel 4789', 'description': 'will be applied by participants once daily for 12-weeks treatment period\n\ndapivirine 4789: dapivirine gel 4789, 0.05%, 2.5g applied once daily'}, {'id': 'OG002', 'title': 'HEC-based Placebo Gel, 2.5g Containing no Dapivirine', 'description': 'Will be applied once daily for 12-weeks treatment period\n\nDrug placebo: HEC-based universal placebo gel, 2.5g applied once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 weeks', 'description': 'A composite endpoint was defined as the percentage of participants with any post-baseline abnormal finding from pelvic/speculum examination, colposcopy finding, STI diagnoses, laboratory test of DAIDS grade 3 or higher and any product-related AE.\n\nDAIDS severity grades are defined as follows:\n\nGrade 1 = mild Grade 2 = moderate Grade 3 = severe Grade 4 = potentially life-threatening Grade 5 = death', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all trial participants who were randomized to one of the three treatment groups.'}, {'type': 'SECONDARY', 'title': 'Changes in the Vaginal Flora', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dapivirine Gel 4759', 'description': 'Will be applied by participants once daily for12-weeks treatment period\n\ndapivirine gel 4759: dapivirine gel 4759, 0.05%, 2.5g applied once daily'}, {'id': 'OG001', 'title': 'Dapivirine Gel 4789', 'description': 'will be applied by participants once daily for 12-weeks treatment period\n\ndapivirine 4789: dapivirine gel 4789, 0.05%, 2.5g applied once daily'}, {'id': 'OG002', 'title': 'HEC-based Placebo Gel, 2.5g Containing no Dapivirine', 'description': 'Will be applied once daily for 12-weeks treatment period\n\nDrug placebo: HEC-based universal placebo gel, 2.5g applied once daily'}], 'classes': [{'title': 'Week 0 : Normal Flora (0-3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}, {'value': '60.5', 'groupId': 'OG001'}, {'value': '54.8', 'groupId': 'OG002'}]}]}, {'title': 'Week 0 : Altered Flora (4-6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '14.3', 'groupId': 'OG000'}, {'value': '11.6', 'groupId': 'OG001'}, {'value': '23.8', 'groupId': 'OG002'}]}]}, {'title': 'Week 0 : Abnormal Flora (7 or more)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '19.0', 'groupId': 'OG000'}, {'value': '27.9', 'groupId': 'OG001'}, {'value': '21.4', 'groupId': 'OG002'}]}]}, {'title': 'Week 4 : Normal Flora (0-3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '67.6', 'groupId': 'OG000'}, {'value': '55.0', 'groupId': 'OG001'}, {'value': '65.9', 'groupId': 'OG002'}]}]}, {'title': 'Week 4 : Altered Flora (4-6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8.1', 'groupId': 'OG000'}, {'value': '12.5', 'groupId': 'OG001'}, {'value': '19.5', 'groupId': 'OG002'}]}]}, {'title': 'Week 4 : Abnormal Flora (7 or more)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '24.3', 'groupId': 'OG000'}, {'value': '32.5', 'groupId': 'OG001'}, {'value': '14.6', 'groupId': 'OG002'}]}]}, {'title': 'Week 12: Normal Flora (0-3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '61.8', 'groupId': 'OG000'}, {'value': '65.7', 'groupId': 'OG001'}, {'value': '59.5', 'groupId': 'OG002'}]}]}, {'title': 'Week 12: Altered Flora (4-6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '23.5', 'groupId': 'OG000'}, {'value': '20.0', 'groupId': 'OG001'}, {'value': '24.3', 'groupId': 'OG002'}]}]}, {'title': 'Week 12: Abnormal Flora (7 or more)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '14.7', 'groupId': 'OG000'}, {'value': '14.3', 'groupId': 'OG001'}, {'value': '16.2', 'groupId': 'OG002'}]}]}, {'title': 'Week 16 (Follow-up after IP discontinuation): Normal Flora (0-3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '70.6', 'groupId': 'OG000'}, {'value': '66.7', 'groupId': 'OG001'}, {'value': '64.9', 'groupId': 'OG002'}]}]}, {'title': 'Week 16 (Follow-up after IP discontinuation): Altered Flora (4-6)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000'}, {'value': '18.2', 'groupId': 'OG001'}, {'value': '18.9', 'groupId': 'OG002'}]}]}, {'title': 'Week 16 (Follow-up after IP discontinuation): Abnormal Flora (7 or more)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '26.5', 'groupId': 'OG000'}, {'value': '15.2', 'groupId': 'OG001'}, {'value': '16.2', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '16 weeks', 'description': 'Cervicovaginal fluid specimens will be obtained to determine vaginal flora before first gel application and at Visits 3, 5, and 6. Appropriate statistical analyses incorporating repeated measures will be used to assess the changes in the vaginal flora in women using Dapivirine Gel 4759, 0.05% 2.5g, Dapivirine Gel 4789, 0.05% 2.5g or the vaginal HEC-based universal placebo gel, 2.5g.\n\nNugent scores were used to assess changes in vaginal flora, and were categorized into three levels: (1) negative for BV (score: 0-3); (2) altered vaginal flora (score: 4-6); and (3) BV (score: 7-10).', 'unitOfMeasure': 'percentage of participants with data', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were assigned to a treatment group were analyzed as members of the group to which they were randomized, regardless of adherence to the planned course of treatment.\n\nResults are reported for participants who provided vaginal samples.'}, {'type': 'SECONDARY', 'title': 'The Distribution of Dapivirine Levels Observed in Plasma Samples at Each Specified Time Point', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dapivirine Gel 4759', 'description': 'Will be applied by participants once daily for12-weeks treatment period\n\ndapivirine gel 4759: dapivirine gel 4759, 0.05%, 2.5g applied once daily'}, {'id': 'OG001', 'title': 'Dapivirine Gel 4789', 'description': 'will be applied by participants once daily for 12-weeks treatment period\n\ndapivirine 4789: dapivirine gel 4789, 0.05%, 2.5g applied once daily'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '536.8', 'spread': '297.2', 'groupId': 'OG000'}, {'value': '475.8', 'spread': '272.2', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '599.5', 'spread': '423.1', 'groupId': 'OG000'}, {'value': '446.1', 'spread': '272.2', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '572.6', 'spread': '377.5', 'groupId': 'OG000'}, {'value': '432.6', 'spread': '276.8', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '519.1', 'spread': '351.3', 'groupId': 'OG000'}, {'value': '366.1', 'spread': '329.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Dapivirine levels observed in plasma will be summarized using simple descriptive statistics.', 'unitOfMeasure': 'picograms/mililiter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis population included all participants who received at least one dose of the active IP and for whom at least one plasma, vaginal fluid or cervical tissue sample was taken.\n\nResults are provided for participants for whom samples were available.'}, {'type': 'SECONDARY', 'title': 'The Adherence to Once Daily Application of a Vaginal Microbicide Gel Over a 12-week Period in Healthy, Sexually Active, HIV-negative Women', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dapivirine Gel 4759', 'description': 'Will be applied by participants once daily for12-weeks treatment period\n\ndapivirine gel 4759: dapivirine gel 4759, 0.05%, 2.5g applied once daily'}, {'id': 'OG001', 'title': 'Dapivirine Gel 4789', 'description': 'will be applied by participants once daily for 12-weeks treatment period\n\ndapivirine 4789: dapivirine gel 4789, 0.05%, 2.5g applied once daily'}, {'id': 'OG002', 'title': 'HEC-based Placebo Gel, 2.5g Containing no Dapivirine', 'description': 'Will be applied once daily for 12-weeks treatment period\n\nDrug placebo: HEC-based universal placebo gel, 2.5g applied once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 weeks', 'description': 'Adherence is defined as the percentage of participants who used the gel each day of the preceding 14 days, based on participant self reports.', 'unitOfMeasure': 'percentage of participants with data', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all trial participants who were randomized to one of the three treatment groups.\n\nResults are provided for participants who reported adherence information.'}, {'type': 'SECONDARY', 'title': 'Changes in the Vaginal pH', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dapivirine Gel 4759', 'description': 'Will be applied by participants once daily for12-weeks treatment period\n\ndapivirine gel 4759: dapivirine gel 4759, 0.05%, 2.5g applied once daily'}, {'id': 'OG001', 'title': 'Dapivirine Gel 4789', 'description': 'will be applied by participants once daily for 12-weeks treatment period\n\ndapivirine 4789: dapivirine gel 4789, 0.05%, 2.5g applied once daily'}, {'id': 'OG002', 'title': 'HEC-based Placebo Gel, 2.5g Containing no Dapivirine', 'description': 'Will be applied once daily for 12-weeks treatment period\n\nDrug placebo: HEC-based universal placebo gel, 2.5g applied once daily'}], 'classes': [{'title': 'Screening (Week 0)', 'categories': [{'measurements': [{'value': '4.46', 'spread': '0.53', 'groupId': 'OG000'}, {'value': '4.55', 'spread': '0.63', 'groupId': 'OG001'}, {'value': '4.55', 'spread': '0.95', 'groupId': 'OG002'}]}]}, {'title': 'Visit 1 (Enrollment)', 'categories': [{'measurements': [{'value': '4.45', 'spread': '0.52', 'groupId': 'OG000'}, {'value': '4.48', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '4.3', 'spread': '0.43', 'groupId': 'OG002'}]}]}, {'title': 'Visit 5 (Week 12)', 'categories': [{'measurements': [{'value': '4.4', 'spread': '0.46', 'groupId': 'OG000'}, {'value': '4.44', 'spread': '0.61', 'groupId': 'OG001'}, {'value': '4.38', 'spread': '0.47', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Cervicovaginal fluid specimens will be obtained to determine vaginal pH before first gel application and at screening, enrolment and visit 5 (week 12). Appropriate statistical analyses incorporating repeated measures will be used to assess the changes in the vaginal pH in women using Dapivirine Gel 4759, 0.05% 2.5g, Dapivirine Gel 4789, 0.05% 2.5g or the vaginal HEC-based universal placebo gel, 2.5g.', 'unitOfMeasure': 'Vaginal pH', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who were assigned to a treatment group were analyzed as members of the group to which they were randomized, regardless of adherence to the planned course of treatment.'}, {'type': 'SECONDARY', 'title': 'The Distribution of Dapivirine Levels Observed in Vaginal Fluid at Each Specified Time Point.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dapivirine Gel 4759', 'description': 'Will be applied by participants once daily for12-weeks treatment period\n\ndapivirine gel 4759: dapivirine gel 4759, 0.05%, 2.5g applied once daily'}, {'id': 'OG001', 'title': 'Dapivirine Gel 4789', 'description': 'will be applied by participants once daily for 12-weeks treatment period\n\ndapivirine 4789: dapivirine gel 4789, 0.05%, 2.5g applied once daily'}], 'classes': [{'title': 'Visit 2 (2 weeks post-enrollment)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '467.1', 'spread': '579.8', 'groupId': 'OG000'}, {'value': '880.7', 'spread': '1924', 'groupId': 'OG001'}]}]}, {'title': 'Visit 3 (4 weeks post-enrolment)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '347.8', 'spread': '351.9', 'groupId': 'OG000'}, {'value': '462.6', 'spread': '590.0', 'groupId': 'OG001'}]}]}, {'title': 'Visit 4 (8 weeks post-enrolment)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '526.9', 'spread': '580.1', 'groupId': 'OG000'}, {'value': '298.1', 'spread': '151', 'groupId': 'OG001'}]}]}, {'title': 'Visit 5a (24 hours after gel discontinuation)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '192.0', 'spread': '186.7', 'groupId': 'OG000'}, {'value': '680.0', 'spread': '1775', 'groupId': 'OG001'}]}]}, {'title': 'Visit 5b (48 hours after gel discontinuation)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.63', 'spread': '180.3', 'groupId': 'OG000'}, {'value': '164.0', 'spread': '233.1', 'groupId': 'OG001'}]}]}, {'title': 'Visit 5c (72 hours after gel discontinuation)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '177.0', 'spread': '304.9', 'groupId': 'OG000'}, {'value': '245.6', 'spread': '230.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks. Measured at 2, 4, and 8 weeks post-enrolment and at one of these at week 12; 24, 48, or 72 hours after gel discontinuation. (Participants were randomized to have vaginal fluid samples collected at one of these visits (5a, 5b, or 5c).', 'description': 'The distribution of dapivirine levels observed in each type of sample will be summarized using simple descriptive statistics. In addition, the proportion of women with detectable dapivirine concentrations will be calculated for each type of sample at each collection time point. Exploratory analyses of dapivirine concentration data will also be performed to take into account information reported in a diary regarding menses and tampon use throughout the trial.', 'unitOfMeasure': 'nanogram/milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis population included all participants who received at least one dose of the active IP and for whom at least one plasma, vaginal fluid or cervical tissue sample was taken.\n\nResults are provided for participants for whom samples were available.'}, {'type': 'SECONDARY', 'title': 'The Distribution of Dapivirine Levels Observed in Vaginal Tissue at Each Specified Time Point.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dapivirine Gel 4759', 'description': 'Will be applied by participants once daily for12-weeks treatment period\n\ndapivirine gel 4759: dapivirine gel 4759, 0.05%, 2.5g applied once daily'}, {'id': 'OG001', 'title': 'Dapivirine Gel 4789', 'description': 'will be applied by participants once daily for 12-weeks treatment period\n\ndapivirine 4789: dapivirine gel 4789, 0.05%, 2.5g applied once daily'}], 'classes': [{'title': 'Visit 5a (24 hours after gel discontinuation)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3518', 'spread': '3579', 'groupId': 'OG000'}, {'value': '9343', 'spread': '18980', 'groupId': 'OG001'}]}]}, {'title': 'Visit 5b (48 hours after gel discontinuation)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '841.0', 'spread': '1582', 'groupId': 'OG000'}, {'value': '1150', 'spread': '1184', 'groupId': 'OG001'}]}]}, {'title': 'Visit 5c (72 hours after gel discontinuation)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4781', 'spread': '9161', 'groupId': 'OG000'}, {'value': '1142', 'spread': '1337', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks. Measured at 2, 4, and 8 weeks post-enrolment and at one of these at week 12; 24, 48, or 72 hours after gel discontinuation. (Participants were randomized to have vaginal fluid samples collected at one of these visits (5a, 5b, or 5c).', 'description': 'The distribution of dapivirine levels observed in vaginal tissue sample will be summarized using simple descriptive statistics.', 'unitOfMeasure': 'nanogram/gram', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis population included all participants who received at least one dose of the active IP and for whom at least one plasma, vaginal fluid or cervical tissue sample was taken.'}, {'type': 'SECONDARY', 'title': 'Acceptability of Once Daily Application of a Vaginal Microbicide Gel Over a 12-week Period in Healthy, Sexually Active, HIV-negative Women', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dapivirine Gel 4789', 'description': 'will be applied by participants once daily for 12-weeks treatment period\n\ndapivirine 4789: dapivirine gel 4789, 0.05%, 2.5g applied once daily'}, {'id': 'OG001', 'title': 'Dapivirine Gel 4759', 'description': 'Will be applied by participants once daily for12-weeks treatment period\n\ndapivirine gel 4759: dapivirine gel 4759, 0.05%, 2.5g applied once daily'}, {'id': 'OG002', 'title': 'HEC-based Placebo Gel, 2.5g Containing no Dapivirine', 'description': 'Will be applied once daily for 12-weeks treatment period\n\nDrug placebo: HEC-based universal placebo gel, 2.5g applied once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 weeks', 'description': 'Acceptability was assessed as the percentage of participants at week 12 who were willing to use the gel every day if proven to prevent HIV.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all trial participants who were randomized to one of the three treatment groups.\n\nResults are reported for participants who provided questionnaire responses.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dapivirine Gel 4789', 'description': 'will be applied by participants once daily for 12-weeks treatment period\n\ndapivirine 4789: dapivirine gel 4789, 0.05%, 2.5g applied once daily'}, {'id': 'FG001', 'title': 'Dapivirine Gel 4759', 'description': 'Will be applied by participants once daily for12-weeks treatment period\n\ndapivirine gel 4759: dapivirine gel 4759, 0.05%, 2.5g applied once daily'}, {'id': 'FG002', 'title': 'HEC-based Placebo Gel, 2.5g Containing no Dapivirine', 'description': 'Will be applied once daily for 12-weeks treatment period\n\nDrug placebo: HEC-based universal placebo gel, 2.5g applied once daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '43'}, {'groupId': 'FG002', 'numSubjects': '42'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '34'}, {'groupId': 'FG002', 'numSubjects': '36'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Not adherent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'discontinued use of IP due to AE, but completed visits', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'IP dispensing error', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'not enough IP to complete trial due to IP dispending error', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'IP discontinued too long during BV treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'lost 2 IP kits and did not have enough remaining to complete trial', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'participant did not attend clinic visit 6 (final visit)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': "Approximately 180 women (35-50 per RC) were scheduled to be enrolled at 5 research centers in the USA. However, following IPM's decision to give priority to development of the dapivirine vaginal ring above that of dapivirine vaginal gel, the Sponsor decided to stop enrollment into IPM 020 trial after 128 participants were randomized. It was determined that the number of participants already enrolled were sufficient to allow for meaningful analysis of the data. Total trial duration was 18 months."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '128', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Dapivirine Gel 4759', 'description': 'Will be applied by participants once daily for12-weeks treatment period\n\ndapivirine gel 4759: dapivirine gel 4759, 0.05%, 2.5g applied once daily'}, {'id': 'BG001', 'title': 'Dapivirine Gel 4789', 'description': 'will be applied by participants once daily for 12-weeks treatment period\n\ndapivirine 4789: dapivirine gel 4789, 0.05%, 2.5g applied once daily'}, {'id': 'BG002', 'title': 'HEC-based Placebo Gel, 2.5g Containing no Dapivirine', 'description': 'Will be applied once daily for 12-weeks treatment period\n\nDrug placebo: HEC-based universal placebo gel, 2.5g applied once daily'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '27.6', 'spread': '5.9', 'groupId': 'BG000'}, {'value': '27.5', 'spread': '5.5', 'groupId': 'BG001'}, {'value': '27.5', 'spread': '5.5', 'groupId': 'BG002'}, {'value': '27.6', 'spread': '5.9', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '128', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '47', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '128', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Married', 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'In a relationship with one partner, not married', 'classes': [{'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '102', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Cohabitating with main partner', 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'In a relationship with multiple partners', 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '163.7', 'spread': '6.8', 'groupId': 'BG000'}, {'value': '163.5', 'spread': '7.4', 'groupId': 'BG001'}, {'value': '161.4', 'spread': '8.9', 'groupId': 'BG002'}, {'value': '162.9', 'spread': '7.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '77.0', 'spread': '17.5', 'groupId': 'BG000'}, {'value': '73.3', 'spread': '14.9', 'groupId': 'BG001'}, {'value': '69.2', 'spread': '18.8', 'groupId': 'BG002'}, {'value': '73.2', 'spread': '17.3', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '28.7', 'spread': '6.3', 'groupId': 'BG000'}, {'value': '27.5', 'spread': '5.9', 'groupId': 'BG001'}, {'value': '26.5', 'spread': '6.1', 'groupId': 'BG002'}, {'value': '27.6', 'spread': '6.1', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/(m^2)', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Healthy, sexually active, HIV-negative women'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Potential participants who provide inform consent will be invited to screen for the trial. All participants who consent to participate in the trial and meet specified inclusion/exclusion criteria will be invited to enrol. At enrolment women will be randomly assigned in a 1:1:1 ratio to one of three groups.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'All enrolled participants will apply gel on a daily basis for 12 weeks, with clinical follow-up visits at weeks 2,4,8 and 12 to monitor safety and acceptability, and a final visit 4 weeks post gel discontinuation (Visit 6, week 16) Dapivirine concentration will be measured in blood and vaginal fluid and cervical tissue.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 128}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'dispFirstSubmitDate': '2017-01-19', 'completionDateStruct': {'date': '2011-01-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-24', 'studyFirstSubmitDate': '2008-11-26', 'dispFirstSubmitQcDate': '2017-01-19', 'resultsFirstSubmitDate': '2022-06-28', 'studyFirstSubmitQcDate': '2008-11-26', 'dispFirstPostDateStruct': {'date': '2017-01-23', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2022-10-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-10-24', 'studyFirstPostDateStruct': {'date': '2008-11-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-10-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-01-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Percentage of Women With the Composite Endpoint of Abnormal Safety Findings.', 'timeFrame': '12 weeks', 'description': 'A composite endpoint was defined as the percentage of participants with any post-baseline abnormal finding from pelvic/speculum examination, colposcopy finding, STI diagnoses, laboratory test of DAIDS grade 3 or higher and any product-related AE.\n\nDAIDS severity grades are defined as follows:\n\nGrade 1 = mild Grade 2 = moderate Grade 3 = severe Grade 4 = potentially life-threatening Grade 5 = death'}], 'secondaryOutcomes': [{'measure': 'Changes in the Vaginal Flora', 'timeFrame': '16 weeks', 'description': 'Cervicovaginal fluid specimens will be obtained to determine vaginal flora before first gel application and at Visits 3, 5, and 6. Appropriate statistical analyses incorporating repeated measures will be used to assess the changes in the vaginal flora in women using Dapivirine Gel 4759, 0.05% 2.5g, Dapivirine Gel 4789, 0.05% 2.5g or the vaginal HEC-based universal placebo gel, 2.5g.\n\nNugent scores were used to assess changes in vaginal flora, and were categorized into three levels: (1) negative for BV (score: 0-3); (2) altered vaginal flora (score: 4-6); and (3) BV (score: 7-10).'}, {'measure': 'The Distribution of Dapivirine Levels Observed in Plasma Samples at Each Specified Time Point', 'timeFrame': '12 weeks', 'description': 'Dapivirine levels observed in plasma will be summarized using simple descriptive statistics.'}, {'measure': 'The Adherence to Once Daily Application of a Vaginal Microbicide Gel Over a 12-week Period in Healthy, Sexually Active, HIV-negative Women', 'timeFrame': '12 weeks', 'description': 'Adherence is defined as the percentage of participants who used the gel each day of the preceding 14 days, based on participant self reports.'}, {'measure': 'Changes in the Vaginal pH', 'timeFrame': '12 weeks', 'description': 'Cervicovaginal fluid specimens will be obtained to determine vaginal pH before first gel application and at screening, enrolment and visit 5 (week 12). Appropriate statistical analyses incorporating repeated measures will be used to assess the changes in the vaginal pH in women using Dapivirine Gel 4759, 0.05% 2.5g, Dapivirine Gel 4789, 0.05% 2.5g or the vaginal HEC-based universal placebo gel, 2.5g.'}, {'measure': 'The Distribution of Dapivirine Levels Observed in Vaginal Fluid at Each Specified Time Point.', 'timeFrame': '12 weeks. Measured at 2, 4, and 8 weeks post-enrolment and at one of these at week 12; 24, 48, or 72 hours after gel discontinuation. (Participants were randomized to have vaginal fluid samples collected at one of these visits (5a, 5b, or 5c).', 'description': 'The distribution of dapivirine levels observed in each type of sample will be summarized using simple descriptive statistics. In addition, the proportion of women with detectable dapivirine concentrations will be calculated for each type of sample at each collection time point. Exploratory analyses of dapivirine concentration data will also be performed to take into account information reported in a diary regarding menses and tampon use throughout the trial.'}, {'measure': 'The Distribution of Dapivirine Levels Observed in Vaginal Tissue at Each Specified Time Point.', 'timeFrame': '12 weeks. Measured at 2, 4, and 8 weeks post-enrolment and at one of these at week 12; 24, 48, or 72 hours after gel discontinuation. (Participants were randomized to have vaginal fluid samples collected at one of these visits (5a, 5b, or 5c).', 'description': 'The distribution of dapivirine levels observed in vaginal tissue sample will be summarized using simple descriptive statistics.'}, {'measure': 'Acceptability of Once Daily Application of a Vaginal Microbicide Gel Over a 12-week Period in Healthy, Sexually Active, HIV-negative Women', 'timeFrame': '12 weeks', 'description': 'Acceptability was assessed as the percentage of participants at week 12 who were willing to use the gel every day if proven to prevent HIV.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['HIV-1 infections'], 'conditions': ['HIV-1 Infections']}, 'descriptionModule': {'briefSummary': 'A double-blind, randomized, placebo-controlled Phase I/II trial to evaluate the safety of dapivirine Gel 4759, 0.05% 2.5 g and dapivirine Gel 4789, 0.05% 2.5 g formulations as compared to the vaginal HEC-based Universal placebo gel, 2.5 g in healthy HIV-negative women', 'detailedDescription': 'This was a double-blind, randomized, placebo-controlled trial, to be conducted over 10 months at five research centers in the USA among 180 healthy, sexually active women, to assess the safety and acceptability of dapivirine Gel 4759, 0.05% 2.5 g, and dapivirine Gel 4789, 0.05% 2.5 g, both vaginal microbicides containing dapivirine, compared to the vaginal HEC-based Universal placebo gel, 2.5 g, containing no active ingredient, used once daily for a period of 12 weeks.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Women 18 to 40 years of age inclusive who can give written informed consent\n2. Available for all visits and consent to follow all procedures scheduled for the trial\n3. Healthy and self-reported sexually active\n4. HIV-negative as determined by an HIV test at time of enrollment\n5. Willing to be on a stable form of contraception\n6. In the absence of the use of exogenous hormone(s), have a self-reported regular menstrual cycle\n7. Upon pelvic/speculum examination and colposcopy at the enrollment visit, the cervix and vagina appear normal as determined by qualified research center staff\n8. Asymptomatic for genital infections at the time of enrollment\n9. Willing to refrain from use of vaginal products or objects for 14 days prior to enrollment and for the duration of the trial.\n10. Documentation of no abnormality on Pap smear within 90 days prior to randomization;\n11. Willing to answer acceptability and adherence questionnaires throughout the trial\n12. Willing to refrain from participation in any other research trial for the duration of this trial\n13. Willing to provide adequate locator information for trial retention purposes and be reachable per local standard procedures\n14. Willing to abstain from all the following criteria beginning 48 hours prior to each trial visit:\n\n * Vaginal intercourse\n * Oral contact with her genitalia\n * Internal vaginal washing\n * Penetration of the vagina by fingers, sex toys, or any other objects, including medications\n15. Willing to abstain from all of the following for 3 days after biopsy procedures:\n\n * Vaginal intercourse\n * Oral contact with her genitalia\n * Internal vaginal washing\n * Penetration of the vagina by fingers, sex toys, or any other objects, including medications\n\nExclusion Criteria:\n\n1. Currently pregnant or having had their last pregnancy outcome within 3 months prior to screening\n2. Currently breast-feeding, or having breastfed within 3 months prior to screening\n3. Receipt of any investigational agent within 60 days prior to screening\n4. Previously participated in any HIV vaccine trial\n5. Untreated urogenital infections within 2 weeks prior to enrollment\n6. Presence of any abnormal physical finding on the vulva, vaginal walls or cervix during pelvic/speculum examination and/or colposcopy\n7. History of significant urogenital or uterine prolapse, undiagnosed vaginal bleeding, or urethral obstruction\n8. Pap smear result at screening that requires cryotherapy, biopsy or treatment (other than for infection)\n9. History of symptomatic or asymptomatic HSV-2\n10. Any Grade 2, 3 or 4 hematology, chemistry or urinalysis laboratory abnormality at baseline\n11. Unexplained, undiagnosed abnormal bleeding per vagina during or following vaginal intercourse; or urogenital surgery within 90 days prior to enrollment\n12. Any history of anaphylaxis or severe allergy resulting in angioedema; or a history of sensitivity/allergy to latex\n13. Any serious acute, chronic or progressive disease\n14. Any condition(s) that, in the opinion of the Investigator, might interfere with adherence to trial requirements or evaluation of the trial objectives'}, 'identificationModule': {'nctId': 'NCT00799058', 'briefTitle': 'A Safety Study of Two Dapivirine (TMC120) Vaginal Gels in the United States', 'organization': {'class': 'INDUSTRY', 'fullName': 'International Partnership for Microbicides, Inc.'}, 'officialTitle': 'A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED PHASE I/II TRIAL TO EVALUATE THE SAFETY OF DAPIVIRINE GEL 4759, 0.05% 2.5g AND DAPIVIRINE GEL 4789, 0.05% 2.5g FORMULATIONS AS COMPARED TO THE VAGINAL HEC-BASED UNIVERSAL PLACEBO GEL, 2.5g IN HEALTHY HIV-NEGATIVE WOMEN', 'orgStudyIdInfo': {'id': 'IPM 020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'dapivirine gel 4789', 'description': 'will be applied by participants once daily for 12-weeks treatment period', 'interventionNames': ['Drug: dapivirine 4789']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'dapivirine gel 4759', 'description': 'Will be applied by participants once daily for12-weeks treatment period', 'interventionNames': ['Drug: dapivirine gel 4759']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'HEC-based placebo gel, 2.5g containing no Dapivirine', 'description': 'Will be applied once daily for 12-weeks treatment period', 'interventionNames': ['Drug: Drug placebo']}], 'interventions': [{'name': 'dapivirine 4789', 'type': 'DRUG', 'otherNames': ['TMC120'], 'description': 'dapivirine gel 4789, 0.05%, 2.5g applied once daily', 'armGroupLabels': ['dapivirine gel 4789']}, {'name': 'dapivirine gel 4759', 'type': 'DRUG', 'otherNames': ['TMC120'], 'description': 'dapivirine gel 4759, 0.05%, 2.5g applied once daily', 'armGroupLabels': ['dapivirine gel 4759']}, {'name': 'Drug placebo', 'type': 'DRUG', 'otherNames': ['HEC-based placebo gel, 2.5g'], 'description': 'HEC-based universal placebo gel, 2.5g applied once daily', 'armGroupLabels': ['HEC-based placebo gel, 2.5g containing no Dapivirine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham, Alabama Microbicide Clinical Research Site (AMCRS)', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '90502', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Harbor-UCLA Medical Center', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Illinois at Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'SNBL Clinical Pharmacology Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '10461', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Albert Einstein College of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Dr Annalene Nel', 'role': 'STUDY_CHAIR', 'affiliation': 'International Partnership for Microbicides'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'International Partnership for Microbicides, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}