Viewing Study NCT00824369

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Ignite Creation Date: 2025-12-24 @ 10:58 PM
Ignite Modification Date: 2026-01-04 @ 4:20 PM
Study NCT ID: NCT00824369
Status: TERMINATED
Last Update Posted: 2014-08-04
First Post: 2009-01-15
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: A Rollover Study For Subjects Discontinuing From UK-453,061 Studies For The Treatment Of HIV-1
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Australia', 'Canada', 'France', 'Germany', 'Mexico', 'Spain', 'Taiwan']}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'End of Study visit or the Early Termination visit', 'description': 'There were no serious adverse events experienced by the subjects in this study.', 'eventGroups': [{'id': 'EG000', 'title': 'Participants From A5271015 - Lersivirine 500 mg Arm', 'description': 'Participants who had received lersivirine 500 mg orally once daily in A5271015 parent study', 'otherNumAtRisk': 5, 'otherNumAffected': 3, 'seriousNumAtRisk': 5, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Participants From A5271015 - Lersivirine 750 mg Arm', 'description': 'Participants who had received lersivirine 750 mg orally once daily in A5271015 parent study', 'otherNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Participants From A5271015 - Efavirenz 600 mg Arm', 'description': 'Participants who had received efavirenz 600 mg orally once daily in A5271015 parent study', 'otherNumAtRisk': 3, 'otherNumAffected': 2, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Participants From A5271022 - Lersivirine 750 mg Arm', 'description': 'Participants who had received lersivirine 750 mg orally once daily in A5271022 parent study', 'otherNumAtRisk': 11, 'otherNumAffected': 6, 'seriousNumAtRisk': 11, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Participants From A5271022 - Lersivirine 1000 mg Arm', 'description': 'Participants who had received lersivirine 1000 mg orally once daily in A5271022 parent study', 'otherNumAtRisk': 12, 'otherNumAffected': 7, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Participants From A5271022 - Etravirine 200 mg Arm', 'description': 'Participants who had received etravirine 200 mg twice daily in A5271022 parent study', 'otherNumAtRisk': 17, 'otherNumAffected': 11, 'seriousNumAtRisk': 17, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Anal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Aphthous stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Jaundice', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Varicella', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Ligament sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Carpal tunnel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Stress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Epididymitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Vaginal discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Rash papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Cheilitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Frequent bowel movements', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Gastrointestinal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Hepatomegaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Acarodermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Onychomycosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Oropharyngeal candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Salpingo-oophoritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Blood thyroid stimulating hormone increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Blood triglycerides increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Low density lipoprotein increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Dyslipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Type 2 diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Flank pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Uterine leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Nerve compression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Breast mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Lichen planus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Treatment-emergent Adverse Events, Serious Adverse Events and Participants Who Discontinued Due to Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '17', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants From A5271015 - Lersivirine 500 mg Arm', 'description': 'Participants who had received lersivirine 500 mg orally once daily in A5271015 parent study'}, {'id': 'OG001', 'title': 'Participants From A5271015 - Lersivirine 750 mg Arm', 'description': 'Participants who had received lersivirine 750 mg orally once daily in A5271015 parent study'}, {'id': 'OG002', 'title': 'Participants From A5271015 - Efavirenz 600 mg Arm', 'description': 'Participants who had received efavirenz 600 mg orally once daily in A5271015 parent study'}, {'id': 'OG003', 'title': 'Participants From A5271022 - Lersivirine 750 mg Arm', 'description': 'Participants who had received lersivirine 750 mg orally once daily in A5271022 parent study'}, {'id': 'OG004', 'title': 'Participants From A5271022 - Lersivirine 1000 mg Arm', 'description': 'Participants who had received lersivirine 1000 mg orally once daily in A5271022 parent study'}, {'id': 'OG005', 'title': 'Participants From A5271022 - Etravirine 200 mg Arm', 'description': 'Participants who had received etravirine 200 mg twice daily in A5271022 parent study'}], 'classes': [{'title': 'Number of participants with adverse events', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '11', 'groupId': 'OG005'}]}]}, {'title': 'Number of participants with serious adverse events', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Participants discontinued due to adverse events', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'End of Study visit or the Early Termination visit', 'description': 'The numbers of participants with treatment emergent adverse events, serious adverse events or discontinuation due to adverse events was reported.', 'unitOfMeasure': 'Number of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population consisted of all participants who were enrolled in this study.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Human Immunodeficiency Virus - 1 (HIV 1) Ribonucleic Acid (RNA) Level <50 Copies/mL at Baseline, Month 6, Month 12 and Last Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '17', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants From A5271015 - Lersivirine 500 mg Arm', 'description': 'Participants who had received lersivirine 500 mg orally once daily in A5271015 parent study'}, {'id': 'OG001', 'title': 'Participants From A5271015 - Lersivirine 750 mg Arm', 'description': 'Participants who had received lersivirine 750 mg orally once daily in A5271015 parent study'}, {'id': 'OG002', 'title': 'Participants From A5271015 - Efavirenz 600 mg Arm', 'description': 'Participants who had received efavirenz 600 mg orally once daily in A5271015 parent study'}, {'id': 'OG003', 'title': 'Participants From A5271022 - Lersivirine 750 mg Arm', 'description': 'Participants who had received lersivirine 750 mg orally once daily in A5271022 parent study'}, {'id': 'OG004', 'title': 'Participants From A5271022 - Lersivirine 1000 mg Arm', 'description': 'Participants who had received lersivirine 1000 mg orally once daily in A5271022 parent study'}, {'id': 'OG005', 'title': 'Participants From A5271022 - Etravirine 200 mg Arm', 'description': 'Participants who had received etravirine 200 mg twice daily in A5271022 parent study'}], 'classes': [{'title': 'Baseline (N = 5, 4, 3, 11, 12, 17)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}]}]}, {'title': 'Month 6 (N = 3, 2, 3, 8, 11, 15)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}]}]}, {'title': 'Month 12 (N = 3, 3, 1, 2, 5, 7)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}]}, {'title': 'Last Visit (N = 4, 3, 3, 11, 12, 17)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Month 6, Month 12 and Last visit', 'description': 'Number of participants with HIV-1 RNA level \\<50 copies/mL plasma was noted at baseline, month 6, month 12 and last visit.', 'unitOfMeasure': 'Number of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population consisted of all participants who were enrolled. The lower limit of quantification of the HIV 1 RNA assays ranged from 20-70 copies/mL as they were performed by local labs. Participants where the HIV-RNA level was with a LLOQ \\> 50 copies/mL were not included in the analysis at the visit of interest. Only available data was used.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With HIV 1 RNA Level <50 Copies/mL or Below the Lower Limit of Quantification (LLOQ) of the Assay at Baseline, Month 6, Month 12 and Last Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '17', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants From A5271015 - Lersivirine 500 mg Arm', 'description': 'Participants who had received lersivirine 500 mg orally once daily in A5271015 parent study'}, {'id': 'OG001', 'title': 'Participants From A5271015 - Lersivirine 750 mg Arm', 'description': 'Participants who had received lersivirine 750 mg orally once daily in A5271015 parent study'}, {'id': 'OG002', 'title': 'Participants From A5271015 - Efavirenz 600 mg Arm', 'description': 'Participants who had received efavirenz 600 mg orally once daily in A5271015 parent study'}, {'id': 'OG003', 'title': 'Participants From A5271022 - Lersivirine 750 mg Arm', 'description': 'Participants who had received lersivirine 750 mg orally once daily in A5271022 parent study'}, {'id': 'OG004', 'title': 'Participants From A5271022 - Lersivirine 1000 mg Arm', 'description': 'Participants who had received lersivirine 1000 mg orally once daily in A5271022 parent study'}, {'id': 'OG005', 'title': 'Participants From A5271022 - Etravirine 200 mg Arm', 'description': 'Participants who had received etravirine 200 mg twice daily in A5271022 parent study'}], 'classes': [{'title': 'Baseline (N = 5, 4, 3, 11, 12, 17)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}]}]}, {'title': 'Month 6 (N = 4, 4, 3, 8, 11, 15)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}]}]}, {'title': 'Month 12 (N = 4, 4, 1, 2, 5, 7)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}]}, {'title': 'Last Visit (N = 5, 4, 3, 11, 12, 17)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Month 6, Month 12 and Last visit', 'description': 'Number of participants with HIV-1 RNA level \\<50 copies/mL plasma or below the lower limit of quantification (LLOQ) of the Assay were noted at Baseline, Month 6, Month 12 and Last visit. The lower limit of quantification (LLOQ) of the HIV 1 RNA assays ranged from 20 to 70 copies/mL as the assay was performed by local labs.', 'unitOfMeasure': 'Number of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population consisted of all participants who were enrolled in this study. Only available data were used.'}, {'type': 'SECONDARY', 'title': 'Absolute Cluster of Differentiation 4+ (CD4+) Cell Count (Cells/uL) at Baseline, Month 6 and Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '17', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants From A5271015 - Lersivirine 500 mg Arm', 'description': 'Participants who had received lersivirine 500 mg orally once daily in A5271015 parent study'}, {'id': 'OG001', 'title': 'Participants From A5271015 - Lersivirine 750 mg Arm', 'description': 'Participants who had received lersivirine 750 mg orally once daily in A5271015 parent study'}, {'id': 'OG002', 'title': 'Participants From A5271015 - Efavirenz 600 mg Arm', 'description': 'Participants who had received efavirenz 600 mg orally once daily in A5271015 parent study'}, {'id': 'OG003', 'title': 'Participants From A5271022 - Lersivirine 750 mg Arm', 'description': 'Participants who had received lersivirine 750 mg orally once daily in A5271022 parent study'}, {'id': 'OG004', 'title': 'Participants From A5271022 - Lersivirine 1000 mg Arm', 'description': 'Participants who had received lersivirine 1000 mg orally once daily in A5271022 parent study'}, {'id': 'OG005', 'title': 'Participants From A5271022 - Etravirine 200 mg Arm', 'description': 'Participants who had received etravirine 200 mg twice daily in A5271022 parent study'}], 'classes': [{'title': 'Baseline (N = 4, 4, 3, 11, 12, 17)', 'categories': [{'measurements': [{'value': '285', 'spread': '97', 'groupId': 'OG000'}, {'value': '574', 'spread': '274', 'groupId': 'OG001'}, {'value': '564', 'spread': '121', 'groupId': 'OG002'}, {'value': '473', 'spread': '191', 'groupId': 'OG003'}, {'value': '411', 'spread': '259', 'groupId': 'OG004'}, {'value': '455', 'spread': '212', 'groupId': 'OG005'}]}]}, {'title': 'Month 6 (N = 4, 4, 2, 8, 11, 15)', 'categories': [{'measurements': [{'value': '456', 'spread': '175', 'groupId': 'OG000'}, {'value': '514', 'spread': '195', 'groupId': 'OG001'}, {'value': '606', 'spread': '120', 'groupId': 'OG002'}, {'value': '615', 'spread': '248', 'groupId': 'OG003'}, {'value': '413', 'spread': '266', 'groupId': 'OG004'}, {'value': '451', 'spread': '221', 'groupId': 'OG005'}]}]}, {'title': 'Month 12 (N = 4, 4, 2, 3, 6, 7)', 'categories': [{'measurements': [{'value': '618', 'spread': '285', 'groupId': 'OG000'}, {'value': '607', 'spread': '326', 'groupId': 'OG001'}, {'value': '556', 'spread': '65', 'groupId': 'OG002'}, {'value': '378', 'spread': '57', 'groupId': 'OG003'}, {'value': '361', 'spread': '309', 'groupId': 'OG004'}, {'value': '452', 'spread': '247', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 6 and Month 12', 'description': "Participant's immunological status assessed by CD4+ lymphocyte count.", 'unitOfMeasure': 'cells/uL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population consisted of all participants who were enrolled in this study. Only available data were used.'}, {'type': 'SECONDARY', 'title': 'CD4+ Cell Count (Percentage) at Baseline, Month 6 and Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '17', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants From A5271015 - Lersivirine 500 mg Arm', 'description': 'Participants who had received lersivirine 500 mg orally once daily in A5271015 parent study'}, {'id': 'OG001', 'title': 'Participants From A5271015 - Lersivirine 750 mg Arm', 'description': 'Participants who had received lersivirine 750 mg orally once daily in A5271015 parent study'}, {'id': 'OG002', 'title': 'Participants From A5271015 - Efavirenz 600 mg Arm', 'description': 'Participants who had received efavirenz 600 mg orally once daily in A5271015 parent study'}, {'id': 'OG003', 'title': 'Participants From A5271022 - Lersivirine 750 mg Arm', 'description': 'Participants who had received lersivirine 750 mg orally once daily in A5271022 parent study'}, {'id': 'OG004', 'title': 'Participants From A5271022 - Lersivirine 1000 mg Arm', 'description': 'Participants who had received lersivirine 1000 mg orally once daily in A5271022 parent study'}, {'id': 'OG005', 'title': 'Participants From A5271022 - Etravirine 200 mg Arm', 'description': 'Participants who had received etravirine 200 mg twice daily in A5271022 parent study'}], 'classes': [{'title': 'Baseline (N = 4, 4, 3, 11, 12, 17)', 'categories': [{'measurements': [{'value': '21', 'spread': '10', 'groupId': 'OG000'}, {'value': '29', 'spread': '9', 'groupId': 'OG001'}, {'value': '26', 'spread': '2', 'groupId': 'OG002'}, {'value': '26', 'spread': '10', 'groupId': 'OG003'}, {'value': '21', 'spread': '12', 'groupId': 'OG004'}, {'value': '23', 'spread': '8', 'groupId': 'OG005'}]}]}, {'title': 'Month 6 (N = 4, 4, 3, 8, 11, 14)', 'categories': [{'measurements': [{'value': '36', 'spread': '14', 'groupId': 'OG000'}, {'value': '31', 'spread': '12', 'groupId': 'OG001'}, {'value': '26', 'spread': '1', 'groupId': 'OG002'}, {'value': '28', 'spread': '12', 'groupId': 'OG003'}, {'value': '22', 'spread': '11', 'groupId': 'OG004'}, {'value': '23', 'spread': '6', 'groupId': 'OG005'}]}]}, {'title': 'Month 12 (N = 4, 4, 3, 3, 6, 6)', 'categories': [{'measurements': [{'value': '38', 'spread': '14', 'groupId': 'OG000'}, {'value': '30', 'spread': '10', 'groupId': 'OG001'}, {'value': '27', 'spread': '7', 'groupId': 'OG002'}, {'value': '26', 'spread': '11', 'groupId': 'OG003'}, {'value': '19', 'spread': '10', 'groupId': 'OG004'}, {'value': '18', 'spread': '7', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 6 and Month 12', 'description': "Participant's immunological status assessed by CD4+ lymphocyte count.", 'unitOfMeasure': 'Percentage of total lymphocytes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population consisted of all participants who were enrolled in this study. Only available data were used.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Participants From A5271015 - Lersivirine 500 mg Arm', 'description': 'Participants who had received lersivirine 500 mg orally once daily in A5271015 parent study'}, {'id': 'FG001', 'title': 'Participants From A5271015 - Lersivirine 750 mg Arm', 'description': 'Participants who had received lersivirine 750 mg orally once daily in A5271015 parent study'}, {'id': 'FG002', 'title': 'Participants From A5271015 - Efavirenz 600 mg Arm', 'description': 'Participants who had received efavirenz 600 mg orally once daily in A5271015 parent study'}, {'id': 'FG003', 'title': 'Participants From A5271022 - Lersivirine 750 mg Arm', 'description': 'Participants who had received lersivirine 750 mg orally once daily in A5271022 parent study'}, {'id': 'FG004', 'title': 'Participants From A5271022 - Lersivirine 1000 mg Arm', 'description': 'Participants who had received lersivirine 1000 mg orally once daily in A5271022 parent study'}, {'id': 'FG005', 'title': 'Participants From A5271022 - Etravirine 200 mg Arm', 'description': 'Participants who had received etravirine 200 mg twice daily in A5271022 parent study'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '11'}, {'groupId': 'FG004', 'numSubjects': '12'}, {'groupId': 'FG005', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '11'}, {'groupId': 'FG005', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Nolonger willing to participate in study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants from two parent studies (A5271015 and A5271022) were included if they discontinued treatment due to virologic failure or other reasons. Participants from 6 countries were enrolled into the A5271015 study and the A5271022 study enrolled participants from 8 countries.', 'preAssignmentDetails': 'Twelve and 40 participants who had received: LRV 500 mg QD, LRV 750 mg QD or efavirenz 600 mg QD (in A5271015);or LRV 750 mg QD, LRV 1000 mg QD or etravirine 200 mg BID (in A5271022) were enrolled and treated with open-label antiretrovirals excluding LRV. Data summaries were provided by the randomized treatment groups of the parent protocol.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '17', 'groupId': 'BG005'}, {'value': '52', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Participants From A5271015 - Lersivirine 500 mg Arm', 'description': 'Participants who had received lersivirine 500 mg orally once daily in A5271015 parent study'}, {'id': 'BG001', 'title': 'Participants From A5271015 - Lersivirine 750 mg Arm', 'description': 'Participants who had received lersivirine 750 mg orally once daily in A5271015 parent study'}, {'id': 'BG002', 'title': 'Participants From A5271015 - Efavirenz 600 mg Arm', 'description': 'Participants who had received efavirenz 600 mg orally once daily in A5271015 parent study'}, {'id': 'BG003', 'title': 'Participants From A5271022 - Lersivirine 750 mg Arm', 'description': 'Participants who had received lersivirine 750 mg orally once daily in A5271022 parent study'}, {'id': 'BG004', 'title': 'Participants From A5271022 - Lersivirine 1000 mg Arm', 'description': 'Participants who had received lersivirine 1000 mg orally once daily in A5271022 parent study'}, {'id': 'BG005', 'title': 'Participants From A5271022 - Etravirine 200 mg Arm', 'description': 'Participants who had received etravirine 200 mg twice daily in A5271022 parent study'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Participants from A5271015', 'categories': [{'measurements': [{'value': '33.8', 'spread': '6.1', 'groupId': 'BG000'}, {'value': '31.5', 'spread': '1.7', 'groupId': 'BG001'}, {'value': '38.3', 'spread': '3.2', 'groupId': 'BG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'This arm belongs to the study A5271022 and not A5271015.', 'groupId': 'BG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'This arm belongs to the study A5271022 and not A5271015.', 'groupId': 'BG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'This arm belongs to the study A5271022 and not A5271015.', 'groupId': 'BG005'}, {'value': '34.2', 'spread': '4.8', 'groupId': 'BG006'}]}]}, {'title': 'Participants from A5271022', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'This arm belongs to the study A5271015 and not A5271022.', 'groupId': 'BG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'This arm belongs to the study A5271015 and not A5271022.', 'groupId': 'BG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'This arm belongs to the study A5271015 and not A5271022.', 'groupId': 'BG002'}, {'value': '42.7', 'spread': '9.1', 'groupId': 'BG003'}, {'value': '39.1', 'spread': '9.0', 'groupId': 'BG004'}, {'value': '41.6', 'spread': '9.4', 'groupId': 'BG005'}, {'value': '41.2', 'spread': '9.1', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '11', 'groupId': 'BG005'}, {'value': '28', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '24', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'whyStopped': 'See termination reason in detailed description.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-31', 'studyFirstSubmitDate': '2009-01-15', 'resultsFirstSubmitDate': '2014-01-16', 'studyFirstSubmitQcDate': '2009-01-15', 'lastUpdatePostDateStruct': {'date': '2014-08-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-07-31', 'studyFirstPostDateStruct': {'date': '2009-01-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-08-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Treatment-emergent Adverse Events, Serious Adverse Events and Participants Who Discontinued Due to Adverse Events', 'timeFrame': 'End of Study visit or the Early Termination visit', 'description': 'The numbers of participants with treatment emergent adverse events, serious adverse events or discontinuation due to adverse events was reported.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Human Immunodeficiency Virus - 1 (HIV 1) Ribonucleic Acid (RNA) Level <50 Copies/mL at Baseline, Month 6, Month 12 and Last Visit', 'timeFrame': 'Baseline, Month 6, Month 12 and Last visit', 'description': 'Number of participants with HIV-1 RNA level \\<50 copies/mL plasma was noted at baseline, month 6, month 12 and last visit.'}, {'measure': 'Number of Participants With HIV 1 RNA Level <50 Copies/mL or Below the Lower Limit of Quantification (LLOQ) of the Assay at Baseline, Month 6, Month 12 and Last Visit', 'timeFrame': 'Baseline, Month 6, Month 12 and Last visit', 'description': 'Number of participants with HIV-1 RNA level \\<50 copies/mL plasma or below the lower limit of quantification (LLOQ) of the Assay were noted at Baseline, Month 6, Month 12 and Last visit. The lower limit of quantification (LLOQ) of the HIV 1 RNA assays ranged from 20 to 70 copies/mL as the assay was performed by local labs.'}, {'measure': 'Absolute Cluster of Differentiation 4+ (CD4+) Cell Count (Cells/uL) at Baseline, Month 6 and Month 12', 'timeFrame': 'Baseline, Month 6 and Month 12', 'description': "Participant's immunological status assessed by CD4+ lymphocyte count."}, {'measure': 'CD4+ Cell Count (Percentage) at Baseline, Month 6 and Month 12', 'timeFrame': 'Baseline, Month 6 and Month 12', 'description': "Participant's immunological status assessed by CD4+ lymphocyte count."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HIV-1', 'Rollover', 'Safety.', 'HIV Infections', 'treatment experienced'], 'conditions': ['HIV-1']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A5271038&StudyName=A%20Rollover%20Study%20For%20Subjects%20Discontinuing%20From%20UK-453%2C061%20Studies%20For%20The%20Treatment%20Of%20HIV-1', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the protocol is to assess long-term safety and tolerability of subjects who discontinue for any reason from UK-453,061 qualifying studies.', 'detailedDescription': 'To assess long term safety and tolerability of subjects who discontinue for any reason from UK-453,061 studies. The study will also assess efficacy of the subsequent regimens in these patients. The trial was terminated prematurely on January 29, 2013, due to the decision of the sponsor to discontinue development of lersivirine. The decision to terminate the trial was not based on any safety or efficacy concerns.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Previous participation in a qualifying study.\n* Male or female at least 18 years of age available for a follow-up period of at least 96 weeks.\n\nExclusion Criteria:\n\n* Concurrent treatment in another clinical trial.\n* Unwilling or unable to be followed for 12 months'}, 'identificationModule': {'nctId': 'NCT00824369', 'briefTitle': 'A Rollover Study For Subjects Discontinuing From UK-453,061 Studies For The Treatment Of HIV-1', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase 2b Open-Label Rollover Study For Subjects Discontinuing From UK-453,061 Studies For The Treatment Of HIV-1 Infected Subjects', 'orgStudyIdInfo': {'id': 'A5271038'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Anti-retroviral therapy', 'description': 'Anti-retroviral therapy', 'interventionNames': ['Drug: No drug will be administered']}], 'interventions': [{'name': 'No drug will be administered', 'type': 'DRUG', 'description': 'No drug will be administered.', 'armGroupLabels': ['Anti-retroviral therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95814', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '33137', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United 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