Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 2:59 AM
Study NCT ID:
NCT01266902
Status:
COMPLETED
Last Update Posted:
2021-03-04
First Post:
2010-12-23
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Trial With TMC278-TIDP6-C222 for Continued TMC278 Access in Patients Infected With Human Immunodeficiency Virus-1
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Brazil', 'Mexico', 'Panama']}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068696', 'term': 'Rilpivirine'}], 'ancestors': [{'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialDisclosure@its.jnj.com', 'phone': '844-434-4210', 'title': 'Director', 'organization': 'Janssen Research & Development, LLC'}, 'certainAgreement': {'otherDetails': 'A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Not all Adverse Events (AEs) were collected; AEs considered related to rilpivirine (RPV), leading to discontinuations, serious adverse events (SAEs), or grade 3/4 events of rash regardless of causality were collected; discontinuation rate was greater than (\\>) 90 percent which makes interpretation of results difficult.'}}, 'adverseEventsModule': {'timeFrame': 'Up to 7 years', 'description': 'Safety analysis included all participants who have taken at least 1 dose of rilpivirine (RPV), regardless of their compliance with the protocol and adherence to the dosing regimen.', 'eventGroups': [{'id': 'EG000', 'title': 'Rilpivirine (RPV) (TMC278-C204 [C204])', 'description': 'Participants who rolled over from trial C204 (NCT00110305) continued to receive RPV 25 milligrams (mg) once daily (qd) in combination with an investigator-selected background regimen consisting of 2 nucleos(t)ide reverse transcriptase inhibitors (N\\[t\\]RTI)s starting Day 1.', 'otherNumAtRisk': 119, 'deathsNumAtRisk': 119, 'otherNumAffected': 25, 'seriousNumAtRisk': 119, 'deathsNumAffected': 0, 'seriousNumAffected': 9}, {'id': 'EG001', 'title': 'RPV (TMC278-TiDP6-C209 [C209] and TMC278-TiDP6-C215 [C215])', 'description': 'Participants who rolled over from trial C209 (NCT00540449) and C215 (NCT00543725) continued to receive RPV 25 mg qd in combination with an investigator-selected background regimen consisting of 2 N(t)RTIs starting Day 1. In trial C209, the background regimen was fixed to tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) and in trial C215, the background regimen was selected by the investigator and contained either abacavir (ABC)/lamivudine (3TC), zidovudine (AZT)/3TC, or TDF/FTC.', 'otherNumAtRisk': 363, 'deathsNumAtRisk': 363, 'otherNumAffected': 61, 'seriousNumAtRisk': 363, 'deathsNumAffected': 2, 'seriousNumAffected': 16}], 'otherEvents': [{'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Anal pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Cheilitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Gingivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Feeling hot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Nodule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Body tinea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Chlamydial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Dengue fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Eye infection toxoplasmal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Fungal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Genital herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Hepatitis C', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Herpes simplex', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Hordeolum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Latent tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Lymph node tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Otitis externa', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Perineal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Periorbital cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Respiratory tract infection viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Syphilis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Bone fissure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Joint injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Skin injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Blood cholesterol increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Blood lactic acid increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Blood triglycerides increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Liver function test abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Hyperuricaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Vitamin D deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Osteopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Tendonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Trismus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Anogenital warts', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Carpal tunnel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Cluster headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Disturbance in attention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 7}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Abnormal dreams', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Dermal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Dermatitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Dyshidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Facial wasting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Lipoatrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Lipodystrophy acquired', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Seborrhoeic dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Skin plaque', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}], 'seriousEvents': [{'term': 'Haemolytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Cardiac hypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Dengue fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Liver abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Syphilis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Hand fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Limb injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Stab wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Adrenal adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Gastric cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 2}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Thrombophlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}, {'term': 'Varicose vein', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 363, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 14.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Time to Virologic Rebound', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '363', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rilpivirine (RPV) (TMC278-C204 [C204])', 'description': 'Participants that rolled over from trial C204 (NCT00110305) continued to receive RPV 25 mg qd in combination with a background regimen consisting of 2 N(t)RTIs starting Day 1.'}, {'id': 'OG001', 'title': 'RPV (TMC278-TiDP6-C209 [C209] and TMC278-TiDP6-C215 [C215])', 'description': 'Participants that rolled over from trial C209 (NCT00540449) and C215 (NCT00543725) continued to receive RPV 25 mg qd in combination with a background regimen consisting of 2 N(t)RTIs starting Day 1. In trial C209, the background regimen was fixed to TDF/FTC and in trial C215, the background regimen was selected by the investigator and contained either ABC/3TC, AZT/3TC, or TDF/FTC.'}], 'classes': [{'title': '>= 50 copies/mL', 'categories': [{'measurements': [{'value': '1670.6', 'spread': '51.32', 'groupId': 'OG000'}, {'value': '1939.3', 'spread': '52.43', 'groupId': 'OG001'}]}]}, {'title': '>= 200 copies/mL', 'categories': [{'measurements': [{'value': '1901.3', 'spread': '47.19', 'groupId': 'OG000'}, {'value': '1877.3', 'spread': '25.93', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Week 360', 'description': 'Time to virologic rebound was time to (first) human immunodeficiency virus type1 (HIV-1) ribonucleic acid (RNA) greater than or equal to (\\>=) 50 or \\>=200 copies/milliliter (copies/mL). The mean survival time and its standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all participants who have taken at least 1 dose of RPV, regardless of their compliance with the protocol and adherence to the dosing regimens.'}, {'type': 'SECONDARY', 'title': 'Time To Treatment Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '363', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rilpivirine (RPV) (TMC278-C204 [C204])', 'description': 'Participants that rolled over from trial C204 (NCT00110305) continued to receive RPV 25 mg qd in combination with a background regimen consisting of 2 N(t)RTIs starting Day 1.'}, {'id': 'OG001', 'title': 'RPV (TMC278-TiDP6-C209 [C209] and TMC278-TiDP6-C215 [C215])', 'description': 'Participants that rolled over from trial C209 (NCT00540449) and C215 (NCT00543725) continued to receive RPV 25 mg qd in combination with a background regimen consisting of 2 N(t)RTIs starting Day 1. In trial C209, the background regimen was fixed to TDF/FTC and in trial C215, the background regimen was selected by the investigator and contained either ABC/3TC, AZT/3TC, or TDF/FTC.'}], 'classes': [{'title': '>= 50 copies/mL', 'categories': [{'measurements': [{'value': '1795.7', 'spread': '70.03', 'groupId': 'OG000'}, {'value': '1694.1', 'spread': '59.42', 'groupId': 'OG001'}]}]}, {'title': '>= 200 copies/mL', 'categories': [{'measurements': [{'value': '1868.7', 'spread': '63.29', 'groupId': 'OG000'}, {'value': '1637.5', 'spread': '42.42', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Week 360', 'description': 'Time to treatment failure was defined as time to virologic rebound (time to first HIV-1 RNA \\>= 50 or \\>= 200 copies/mL) or discontinuation for reason other than RPV having become commercially available in the participating country, whichever came first, calculated as the time (in days) from baseline until treatment failure. The mean survival time and its standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all participants who have taken at least 1 dose of RPV, regardless of their compliance with the protocol and adherence to the dosing regimen.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Count for Observed Case Approach Until Week 336', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '363', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rilpivirine (RPV) (TMC278-C204 [C204])', 'description': 'Participants that rolled over from trial C204 (NCT00110305) continued to receive RPV 25 mg qd in combination with a background regimen consisting of 2 N(t)RTIs starting Day 1.'}, {'id': 'OG001', 'title': 'RPV (TMC278-TiDP6-C209 [C209] and TMC278-TiDP6-C215 [C215])', 'description': 'Participants that rolled over from trial C209 (NCT00540449) and C215 (NCT00543725) continued to receive RPV 25 mg qd in combination with a background regimen consisting of 2 N(t)RTIs starting Day 1. In trial C209, the background regimen was fixed to TDF/FTC and in trial C215, the background regimen was selected by the investigator and contained either ABC/3TC, AZT/3TC, or TDF/FTC.'}], 'classes': [{'title': 'Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72.63', 'spread': '20.581', 'groupId': 'OG000'}, {'value': '55.91', 'spread': '13.425', 'groupId': 'OG001'}]}]}, {'title': 'Week 192', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '148.76', 'spread': '24.111', 'groupId': 'OG000'}, {'value': '132.73', 'spread': '21.989', 'groupId': 'OG001'}]}]}, {'title': 'Week 288', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '122.29', 'spread': '29.628', 'groupId': 'OG000'}, {'value': '101.50', 'spread': '24.108', 'groupId': 'OG001'}]}]}, {'title': 'Week 336', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '161.73', 'spread': '39.851', 'groupId': 'OG000'}, {'value': '76.49', 'spread': '40.484', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to weeks 96, 192, 288, 336', 'description': 'The immunologic assessment was determined by change from baseline in CD4+ cell count for observed case approach.', 'unitOfMeasure': 'cells/microliter (cells/mcL)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "The ITT population included all participants who have taken at least 1 dose of RPV, regardless of their compliance with the protocol and adherence to the dosing regimen. Here 'number of participants analyzed' signifies number of participants analyzed in this outcome measure. Here 'number analyzed' included all participants evaluable at specified timepoint categories."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in CD4+ Cell Count for Non-Completer Equals Failure (NC=F) Approach Until Week 336', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '363', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rilpivirine (RPV) (TMC278-C204 [C204])', 'description': 'Participants that rolled over from trial C204 (NCT00110305) continued to receive RPV 25 mg qd in combination with a background regimen consisting of 2 N(t)RTIs starting Day 1.'}, {'id': 'OG001', 'title': 'RPV (TMC278-TiDP6-C209 [C209] and TMC278-TiDP6-C215 [C215])', 'description': 'Participants that rolled over from trial C209 (NCT00540449) and C215 (NCT00543725) continued to receive RPV 25 mg qd in combination with a background regimen consisting of 2 N(t)RTIs starting Day 1. In trial C209, the background regimen was fixed to TDF/FTC and in trial C215, the background regimen was selected by the investigator and contained either ABC/3TC, AZT/3TC, or TDF/FTC.'}], 'classes': [{'title': 'Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '69.76', 'spread': '19.372', 'groupId': 'OG000'}, {'value': '42.19', 'spread': '11.525', 'groupId': 'OG001'}]}]}, {'title': 'Week 192', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '133.56', 'spread': '21.906', 'groupId': 'OG000'}, {'value': '91.69', 'spread': '15.563', 'groupId': 'OG001'}]}]}, {'title': 'Week 288', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '92.12', 'spread': '22.809', 'groupId': 'OG000'}, {'value': '63.33', 'spread': '17.132', 'groupId': 'OG001'}]}]}, {'title': 'Week 336', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '70.69', 'spread': '23.558', 'groupId': 'OG000'}, {'value': '49.24', 'spread': '16.688', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to weeks 96, 192, 288, 336', 'description': 'Change from baseline in CD4+ cell count were reported for NC=F approach (participants who discontinued because RPV became commercially available or could be accessed through another source or because the participants switched to other local \\[RPV-based\\] treatment options or local standard of care, were censored at that time; other participants after discontinuation had their CD4+ values imputed with baseline value. Intermittently missing values were imputed with a last observation carried-forward approach).', 'unitOfMeasure': 'cells/mcL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "The ITT population included all participants who have taken at least 1 dose of RPV, regardless of their compliance with the protocol and adherence to the dosing regimen. Here 'number of participants analyzed' signifies number of participants analyzed in this outcome measure. Here 'number analyzed' included all participants evaluable at specified timepoint categories."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '363', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rilpivirine (RPV) (TMC278-C204 [C204])', 'description': 'Participants that rolled over from trial C204 (NCT00110305) continued to receive RPV 25 mg qd in combination with a background regimen consisting of 2 N(t)RTIs starting Day 1.'}, {'id': 'OG001', 'title': 'RPV (TMC278-TiDP6-C209 [C209] and TMC278-TiDP6-C215 [C215])', 'description': 'Participants that rolled over from trial C209 (NCT00540449) and C215 (NCT00543725) continued to receive RPV 25 mg qd in combination with a background regimen consisting of 2 N(t)RTIs starting Day 1. In trial C209, the background regimen was fixed to TDF/FTC and in trial C215, the background regimen was selected by the investigator and contained either ABC/3TC, AZT/3TC, or TDF/FTC.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 7 years', 'description': 'A SAE is any untoward medical occurrence that at any dose: results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all participants who have taken at least 1 dose of RPV, regardless of their compliance with the protocol and adherence to the dosing regimens.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '363', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rilpivirine (RPV) (TMC278-C204 [C204])', 'description': 'Participants that rolled over from trial C204 (NCT00110305) continued to receive RPV 25 milligrams (mg) once daily (qd) in combination with a background regimen consisting of 2 nucleos(t)ide reverse transcriptase inhibitors (N\\[t\\]RTI)s starting Day 1.'}, {'id': 'OG001', 'title': 'RPV (TMC278-TiDP6-C209 [C209] and TMC278-TiDP6-C215 [C215])', 'description': 'Participants that rolled over from trial C209 (NCT00540449) and C215 (NCT00543725) continued to receive RPV 25 mg qd in combination with a background regimen consisting of 2 N(t)RTIs starting Day 1. In trial C209, the background regimen was fixed to tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) and in trial C215, the background regimen was selected by the investigator and contained either abacavir (ABC)/lamivudine (3TC), zidovudine (AZT)/3TC, or TDF/FTC.'}], 'classes': [{'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 7 years', 'description': 'An AE can be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non investigational) product, whether or not related to that medicinal (investigational or non investigational) product.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population included all participants who have taken at least 1 dose of rilpivirine (RPV), regardless of their compliance with the protocol and adherence to the dosing regimens.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Grade 3/4 Events of Rash Irrespective of Causality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '363', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rilpivirine (RPV) (TMC278-C204 [C204])', 'description': 'Participants that rolled over from trial C204 (NCT00110305) continued to receive RPV 25 mg qd in combination with a background regimen consisting of 2 N(t)RTIs starting Day 1.'}, {'id': 'OG001', 'title': 'RPV (TMC278-TiDP6-C209 [C209] and TMC278-TiDP6-C215 [C215])', 'description': 'Participants that rolled over from trial C209 (NCT00540449) and C215 (NCT00543725) continued to receive RPV 25 mg qd in combination with a background regimen consisting of 2 N(t)RTIs starting Day 1. In trial C209, the background regimen was fixed to TDF/FTC and in trial C215, the background regimen was selected by the investigator and contained either ABC/3TC, AZT/3TC, or TDF/FTC.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 7 years', 'description': 'Number of participants with grade 3/4 events of rash irrespective of causality were assessed. A grade 3 rash defined as diffuse macular, maculopapular or morbilliform rash with vesicles or limited number of bullae or; rash with superficial ulcerations of mucous membranes limited to 1 anatomical site or; rash with at least one of the following: elevations in aspartate aminotransferase (AST)/alanine aminotransferase (ALT) more than 2\\*baseline value and at least 5 times upper limit of normal; fever greater than (\\>) 38 degree celsius or 100 degree fahrenheit; eosinophils \\> 1000/millimeter (mm)\\^3; serum sickness-like reaction. A grade 4 rash defined as the following: extensive or generalized bullous lesions or; Stevens-Johnsons Syndrome (SJS) or ulceration of mucous membrane involving 2 or more distinct mucosal sites or toxic epidermal necrolysis.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all participants who have taken at least 1 dose of RPV, regardless of their compliance with the protocol and adherence to the dosing regimens.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With AEs Related to Rilpivirine (RPV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '363', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rilpivirine (RPV) (TMC278-C204 [C204])', 'description': 'Participants that rolled over from trial C204 (NCT00110305) continued to receive RPV 25 mg qd in combination with a background regimen consisting of 2 N(t)RTIs starting Day 1.'}, {'id': 'OG001', 'title': 'RPV (TMC278-TiDP6-C209 [C209] and TMC278-TiDP6-C215 [C215])', 'description': 'Participants that rolled over from trial C209 (NCT00540449) and C215 (NCT00543725) continued to receive RPV 25 mg qd in combination with a background regimen consisting of 2 N(t)RTIs starting Day 1. In trial C209, the background regimen was fixed to TDF/FTC and in trial C215, the background regimen was selected by the investigator and contained either ABC/3TC, AZT/3TC, or TDF/FTC.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 7 years', 'description': 'Number of participants with AEs related to RPV were assessed. An AE can be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non investigational) product, whether or not related to that medicinal (investigational or non investigational) product.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population included all participants who have taken at least 1 dose of RPV, regardless of their compliance with the protocol and adherence to the dosing regimens.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Rilpivirine (RPV) (TMC278-C204 [C204])', 'description': 'Participants who rolled over from trial C204 (NCT00110305) continued to receive RPV 25 milligrams (mg) once daily (qd) in combination with an investigator-selected background regimen consisting of 2 nucleos(t)ide reverse transcriptase inhibitors (N\\[t\\]RTI)s starting Day 1.'}, {'id': 'FG001', 'title': 'RPV (TMC278-TiDP6-C209 [C209] and TMC278-TiDP6-C215 [C215])', 'description': 'Participants who rolled over from trial C209 (NCT00540449) and C215 (NCT00543725) continued to receive RPV 25 mg qd in combination with an investigator-selected background regimen consisting of 2 N(t)RTIs starting Day 1. In trial C209, the background regimen was fixed to tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) and in trial C215, the background regimen was selected by the investigator and contained either abacavir (ABC)/lamivudine (3TC), zidovudine (AZT)/3TC, or TDF/FTC.'}, {'id': 'FG002', 'title': 'RPV 25 mg (After Protocol Amendment 3)', 'description': 'All Participants who were continued under a simplified study setting with only a minimum of study-related activities, as per Protocol Amendment 3 continued to receive RPV 25 mg and followed up for safety.'}], 'periods': [{'title': 'Period 1 (Main Study)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '119'}, {'groupId': 'FG001', 'numSubjects': '363'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '89'}, {'groupId': 'FG001', 'numSubjects': '282'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '81'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': "Investigator's decision/Participant's decision", 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Subject non-compliant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Continued RPV treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '34'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Period 2 (After Protocol Amendment 3)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '45'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '37'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '6'}]}]}], 'preAssignmentDetails': 'Total of 482 participants were treated and 437 discontinued at data cut-off date (8 February 2018) because they switched to commercially available rilpivirine (RPV) (371 participants), as planned per protocol. Only 6 of the 482 participants discontinued as they reached a virologic endpoint. At last contact date of last participant under Protocol Amendment 3 (28 February 2020), out of 45 participants 37 switched to commercially available RPV and 6 were lost to follow-up.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'BG000'}, {'value': '363', 'groupId': 'BG001'}, {'value': '482', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Rilpivirine (RPV) (TMC278-C204 [C204])', 'description': 'Participants who rolled over from trial C204 (NCT00110305) continued to receive RPV 25 milligrams (mg) once daily (qd) in combination with an investigator-selected background regimen consisting of 2 nucleos(t)ide reverse transcriptase inhibitors (N\\[t\\]RTI)s starting Day 1.'}, {'id': 'BG001', 'title': 'RPV (TMC278-TiDP6-C209 [C209] and TMC278-TiDP6-C215 [C215])', 'description': 'Participants who rolled over from trial C209 (NCT00540449) and C215 (NCT00543725) continued to receive RPV 25 mg qd in combination with an investigator-selected background regimen consisting of 2 N(t)RTIs starting Day 1. In trial C209, the background regimen was fixed to tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) and in trial C215, the background regimen was selected by the investigator and contained either abacavir (ABC)/lamivudine (3TC), zidovudine (AZT)/3TC, or TDF/FTC.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42', 'spread': '8.18', 'groupId': 'BG000'}, {'value': '39.9', 'spread': '9.09', 'groupId': 'BG001'}, {'value': '40.4', 'spread': '8.91', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '78', 'groupId': 'BG000'}, {'value': '279', 'groupId': 'BG001'}, {'value': '357', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '237', 'groupId': 'BG001'}, {'value': '287', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'ARGENTINA', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}, {'title': 'AUSTRALIA', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'AUSTRIA', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'BELGIUM', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': 'CANADA', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}, {'title': 'CHILE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'CHINA', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}, {'title': 'DENMARK', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'FRANCE', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}, {'title': 'GERMANY', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}, {'title': 'ITALY', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': 'NETHERLANDS', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'PUERTO RICO', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'ROMANIA', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'RUSSIAN FEDERATION', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}, {'title': 'SOUTH AFRICA', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}, {'title': 'SPAIN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': 'SWEDEN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'TAIWAN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'THAILAND', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}]}, {'title': 'UNITED KINGDOM', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}, {'title': 'UNITED STATES', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-11-28', 'size': 1306237, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-02-10T06:35', 'hasProtocol': True}, {'date': '2018-03-26', 'size': 820265, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-02-10T06:35', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 482}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'nctId': 'NCT03847376', 'statusForNctId': 'APPROVED_FOR_MARKETING', 'hasExpandedAccess': True}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-10', 'studyFirstSubmitDate': '2010-12-23', 'resultsFirstSubmitDate': '2021-02-10', 'studyFirstSubmitQcDate': '2010-12-23', 'lastUpdatePostDateStruct': {'date': '2021-03-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-02-10', 'studyFirstPostDateStruct': {'date': '2010-12-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Adverse Events (AEs)', 'timeFrame': 'Up to 7 years', 'description': 'An AE can be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non investigational) product, whether or not related to that medicinal (investigational or non investigational) product.'}, {'measure': 'Number of Participants With Grade 3/4 Events of Rash Irrespective of Causality', 'timeFrame': 'Up to 7 years', 'description': 'Number of participants with grade 3/4 events of rash irrespective of causality were assessed. A grade 3 rash defined as diffuse macular, maculopapular or morbilliform rash with vesicles or limited number of bullae or; rash with superficial ulcerations of mucous membranes limited to 1 anatomical site or; rash with at least one of the following: elevations in aspartate aminotransferase (AST)/alanine aminotransferase (ALT) more than 2\\*baseline value and at least 5 times upper limit of normal; fever greater than (\\>) 38 degree celsius or 100 degree fahrenheit; eosinophils \\> 1000/millimeter (mm)\\^3; serum sickness-like reaction. A grade 4 rash defined as the following: extensive or generalized bullous lesions or; Stevens-Johnsons Syndrome (SJS) or ulceration of mucous membrane involving 2 or more distinct mucosal sites or toxic epidermal necrolysis.'}], 'secondaryOutcomes': [{'measure': 'Time to Virologic Rebound', 'timeFrame': 'Up to Week 360', 'description': 'Time to virologic rebound was time to (first) human immunodeficiency virus type1 (HIV-1) ribonucleic acid (RNA) greater than or equal to (\\>=) 50 or \\>=200 copies/milliliter (copies/mL). The mean survival time and its standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time.'}, {'measure': 'Time To Treatment Failure', 'timeFrame': 'Up to Week 360', 'description': 'Time to treatment failure was defined as time to virologic rebound (time to first HIV-1 RNA \\>= 50 or \\>= 200 copies/mL) or discontinuation for reason other than RPV having become commercially available in the participating country, whichever came first, calculated as the time (in days) from baseline until treatment failure. The mean survival time and its standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time.'}, {'measure': 'Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Count for Observed Case Approach Until Week 336', 'timeFrame': 'Baseline up to weeks 96, 192, 288, 336', 'description': 'The immunologic assessment was determined by change from baseline in CD4+ cell count for observed case approach.'}, {'measure': 'Change From Baseline in CD4+ Cell Count for Non-Completer Equals Failure (NC=F) Approach Until Week 336', 'timeFrame': 'Baseline up to weeks 96, 192, 288, 336', 'description': 'Change from baseline in CD4+ cell count were reported for NC=F approach (participants who discontinued because RPV became commercially available or could be accessed through another source or because the participants switched to other local \\[RPV-based\\] treatment options or local standard of care, were censored at that time; other participants after discontinuation had their CD4+ values imputed with baseline value. Intermittently missing values were imputed with a last observation carried-forward approach).'}, {'measure': 'Number of Participants With Serious Adverse Events (SAEs)', 'timeFrame': 'Up to 7 years', 'description': 'A SAE is any untoward medical occurrence that at any dose: results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect.'}, {'measure': 'Number of Participants With AEs Related to Rilpivirine (RPV)', 'timeFrame': 'Up to 7 years', 'description': 'Number of participants with AEs related to RPV were assessed. An AE can be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non investigational) product, whether or not related to that medicinal (investigational or non investigational) product.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HIV-1 Infection', 'HIV-1', 'HIV', 'TMC278-TiDP6-C222', 'TMC278-C222', 'TMC278', 'Rilpivirine'], 'conditions': ['HIV-1 Infection']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to provide continued access to TMC278 in HIV-1 infected patients who were randomized and treated with TMC278 in the Phase IIb or Phase III trials.', 'detailedDescription': 'This is a Phase III, open-label (all people know the identity of the drug), multicenter, roll-over trial to provide continued access to TMC278 to HIV-1 infected patients who were randomized (the study drug is assigned by chance) and treated with TMC278 in the Phase IIb (TMC278-C204 \\[C204\\]) or Phase III trials (i.e., TMC278-TiDP6-C209 \\[C209\\] or TMC278-TiDP6-C215 \\[C215\\]) and who continue to benefit from their antiretroviral treatment, according to the investigator. In addition, information on the long-term safety and tolerability, including resistance data in case of virologic failures, of oral doses of TMC278 25 mg once daily (q.d.) in combination with a background regimen containing 2 N(t)RTIs will be collected. Available efficacy data will also be collected. Approximately 750 HIV-1 infected individuals are expected to participate in this trial. The duration of participation in the study for an individual participant will be 2 to 3 years. The final/withdrawal visit of the Phase IIb or Phase III trials will be the first visit of this trial. Safety and tolerability will be evaluated throughout the trial. Visits and assessments performed should be based on the local, generally accepted standard of care, with visits occurring at least every 6 months. Oral tablets of TMC278 25 mg once daily (q.d.) should be administered together with a meal.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients are HIV-1 infected and were previously randomized to receive TMC278 in a TMC278 clinical trial and completed the protocol-defined treatment period.\n* Patients continue to benefit from treatment with TMC278 in the opinion of the investigator.\n* Patient can comply with the current protocol requirements.\n* The patient's general medical condition, in the investigator's opinion, does not interfere with participation in the trial.\n\nExclusion Criteria:\n\n* Use of disallowed concomitant therapy.\n* Females of childbearing potential who are pregnant, or without the use of effective birth control methods, or not willing to continue practicing these birth control methods during the trial and for at least 1 month after the end of the trial (or last intake of TMC278).\n* Non-vasectomized heterosexually active male patients without the use of effective birth control methods or not willing to continue practicing these birth control methods during the trial and for at least 1 month after the end of the trial (or after last intake of TMC278)."}, 'identificationModule': {'nctId': 'NCT01266902', 'briefTitle': 'A Trial With TMC278-TIDP6-C222 for Continued TMC278 Access in Patients Infected With Human Immunodeficiency Virus-1', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen R&D Ireland'}, 'officialTitle': "An Open-label Trial With TMC278 25 mg q.d. in Combination With a Background Regimen Containing 2 N(t)RTI's in HIV-1 Infected Subjects Who Participated in TMC278 Clinical Trials and Were Still Benefitting From Treatment With TMC278", 'orgStudyIdInfo': {'id': 'CR017434'}, 'secondaryIdInfos': [{'id': 'TMC278-TiDP6-C222', 'type': 'OTHER', 'domain': 'Janssen R&D Ireland'}, {'id': '2010-021209-18', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rilpivirine', 'description': 'Rilpivirine 25 mg once daily', 'interventionNames': ['Drug: Rilpivirine']}], 'interventions': [{'name': 'Rilpivirine', 'type': 'DRUG', 'description': '25 mg once daily', 'armGroupLabels': ['Rilpivirine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'Miami Beach', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.79065, 'lon': -80.13005}}, {'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 42.35843, 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'Portland', 'state': 'Oregon', 'country': 'United States', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'city': 'Longview', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.5007, 'lon': -94.74049}}, {'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'city': 'Buenos Aires', 'country': 'Argentina', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'Ciudad Autonoma Buenos Aires', 'country': 'Argentina'}, {'city': 'Córdoba', 'country': 'Argentina', 'geoPoint': {'lat': -31.40648, 'lon': -64.18853}}, {'city': 'Guernica', 'country': 'Argentina', 'geoPoint': {'lat': -34.9162, 'lon': -58.38111}}, {'city': 'Rosario', 'country': 'Argentina', 'geoPoint': {'lat': -32.94682, 'lon': -60.63932}}, {'city': 'Darlinghurst', 'country': 'Australia', 'geoPoint': {'lat': -33.87939, 'lon': 151.21925}}, {'city': 'Melbourne', 'country': 'Australia', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'city': 'Perth', 'country': 'Australia', 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}, {'city': 'Surry Hills', 'country': 'Australia', 'geoPoint': {'lat': -33.88374, 'lon': 151.21282}}, {'city': 'Victoria', 'country': 'Australia'}, {'city': 'Vienna', 'country': 'Austria', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'Antwerp', 'country': 'Belgium', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'city': 'Brussels', 'country': 'Belgium', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'Ghent', 'country': 'Belgium', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'city': 'Leuven', 'country': 'Belgium', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Montreal', 'country': 'Canada', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Santiago', 'country': 'Chile', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'city': 'Beijing', 'country': 'China', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Guangzhou', 'country': 'China', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Shanghai', 'country': 'China', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Copenhagen', 'country': 'Denmark', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'city': 'Hvidovre', 'country': 'Denmark', 'geoPoint': {'lat': 55.64297, 'lon': 12.47708}}, {'city': 'Odense', 'country': 'Denmark', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}, {'city': 'Clamart', 'country': 'France', 'geoPoint': {'lat': 48.80299, 'lon': 2.26692}}, {'city': 'Lyon', 'country': 'France', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Nantes', 'country': 'France', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Paris', 'country': 'France', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Tourcoing', 'country': 'France', 'geoPoint': {'lat': 50.72391, 'lon': 3.16117}}, {'city': 'Berlin', 'country': 'Germany', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Cologne', 'country': 'Germany', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'city': 'Essen', 'country': 'Germany', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'city': 'Frankfurt', 'country': 'Germany', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'city': 'Hamburg', 'country': 'Germany', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Hanover', 'country': 'Germany', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'city': 'Rotterdam', 'country': 'Netherlands', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'city': 'San Juan', 'country': 'Puerto Rico', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}, {'city': 'Bucharest', 'country': 'Romania', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Iași', 'country': 'Romania', 'geoPoint': {'lat': 47.16667, 'lon': 27.6}}, {'city': "Kazan'", 'country': 'Russia', 'geoPoint': {'lat': 55.78874, 'lon': 49.12214}}, {'city': 'Krasnodar', 'country': 'Russia', 'geoPoint': {'lat': 45.04534, 'lon': 38.98178}}, {'city': 'Moscow', 'country': 'Russia', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Saint Petersburg', 'country': 'Russia', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'city': 'Smolensk', 'country': 'Russia', 'geoPoint': {'lat': 54.77826, 'lon': 32.05088}}, {'city': 'Volgograd', 'country': 'Russia', 'geoPoint': {'lat': 48.71378, 'lon': 44.4976}}, {'city': 'Voronezh', 'country': 'Russia', 'geoPoint': {'lat': 51.66833, 'lon': 39.19204}}, {'city': 'Bloemfontein', 'country': 'South Africa', 'geoPoint': {'lat': -29.12107, 'lon': 26.214}}, {'city': 'Dundee', 'country': 'South Africa', 'geoPoint': {'lat': -28.16678, 'lon': 30.23371}}, {'city': 'Durban', 'country': 'South Africa', 'geoPoint': {'lat': -29.8579, 'lon': 31.0292}}, {'city': 'Johannesburg', 'country': 'South Africa', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}, {'city': 'Johannesburg 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'Brighton', 'country': 'United Kingdom', 'geoPoint': {'lat': 50.82838, 'lon': -0.13947}}, {'city': 'London', 'country': 'United Kingdom', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'Manchester', 'country': 'United Kingdom', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'overallOfficials': [{'name': 'Janssen R&D Ireland Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Janssen R&D Ireland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Janssen R&D Ireland', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}