Ignite Creation Date:
2025-12-24 @ 7:17 PM
Ignite Modification Date:
2026-01-03 @ 7:31 PM
Study NCT ID:
NCT03754803
Status:
COMPLETED
Last Update Posted:
2025-08-17
First Post:
2018-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Description of Real World Antiviral Effectiveness and Sustainability of the 2-Drug Regimen Dolutegravir + Lamivudine in Untreated and Pre-treated Patients in Routine Clinical Care in Germany
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C066906', 'term': 'SDM'}, {'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'GSKClinicalSupportHD@gsk.com', 'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': 'GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Serious adverse events and all-cause mortality were collected from Baseline until Year 3. Baseline representing the last visit before the start of therapy with DTG+/3TC.', 'description': 'In line with the pharmacovigilance plan and SOP for safety data collection in post-marketing non-interventional studies not classified as PASS, only serious and/or drug-related adverse events were required to be collected. Therefore, other adverse events were not collected for this study.\n\nThe analysis was performed on the Safety Analysis Set. As per protocol, SAEs and all-cause mortality data were analyzed separately for ART-naive and pre-treated participants.', 'eventGroups': [{'id': 'EG000', 'title': 'ART-naive Participants', 'description': 'Antiretroviral treatment (ART) naïve HIV-1 positive participants for whom DTG+3TC is indicated according to local label.', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 0, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Pre-treated Participants', 'description': 'Pre-treated HIV-1 positive participants for whom DTG+3TC is indicated according to local label.', 'otherNumAtRisk': 337, 'deathsNumAtRisk': 337, 'otherNumAffected': 0, 'seriousNumAtRisk': 337, 'deathsNumAffected': 2, 'seriousNumAffected': 78}], 'seriousEvents': [{'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 337, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 337, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Ischaemic cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Fanconi syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Macular degeneration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Macular hole', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Obstructive pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 337, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Bile duct stone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Anal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Medical device site infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Pneumococcal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 337, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 337, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Postoperative wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Craniocerebral injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 337, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Lower limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Skull fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Tendon rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Toxicity to various agents', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Transaminases increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Joint effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Anal squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 337, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Bladder transitional cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': "Kaposi's sarcoma", 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Laryngeal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Lung adenocarcinoma stage IV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Malignant melanoma in situ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Oropharyngeal neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Device dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 337, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Drug abuse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Schizophrenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Cervical dysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 337, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Acute respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Dyspnoea exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Pulmonary thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Family stress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Cardioversion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Embolism arterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 337, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Percentage of Participants With Low Level Viremia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '335', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ART-naive Participants', 'description': 'Antiretroviral treatment (ART) naïve HIV-1 positive participants for whom DTG+3TC is indicated according to local label.'}, {'id': 'OG001', 'title': 'Pre-treated Participants', 'description': 'Pre-treated HIV-1 positive participants for whom DTG+3TC is indicated according to local label.'}], 'classes': [{'title': 'Month 6', 'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000'}, {'value': '1.8', 'groupId': 'OG001'}]}]}, {'title': 'Year 1', 'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000'}, {'value': '1.5', 'groupId': 'OG001'}]}]}, {'title': 'Year 2', 'categories': [{'measurements': [{'value': '6.5', 'groupId': 'OG000'}, {'value': '0.9', 'groupId': 'OG001'}]}]}, {'title': 'Year 3', 'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000'}, {'value': '1.8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Month 6 and years 1, 2 and 3', 'description': 'Low level viremia is defined as a VL measurement greater than (\\>) 50 - \\<200 c/mL for pre-treated participants. For naive participants, a VL measurement between \\>50 to \\<200 c/mL after initial suppression of \\<50 c/mL was evaluated.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ES, which includes all participants from the FAS except those excluded for various reasons, such as protocol violations and participant withdrawal. As per protocol, data for this outcome measure were analyzed separately for ART-naive and Pre-treated participants, as the variable required different and/or additional response options depending on prior treatment status.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Virologic Rebound', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '335', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ART-naive Participants', 'description': 'Antiretroviral treatment (ART) naïve HIV-1 positive participants for whom DTG+3TC is indicated according to local label.'}, {'id': 'OG001', 'title': 'Pre-treated Participants', 'description': 'Pre-treated HIV-1 positive participants for whom DTG+3TC is indicated according to local label.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000'}, {'value': '0.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline until Year 3', 'description': 'Virologic rebound is defined as 2 consecutive VL measurements \\>=200 c/mL after suppression. Baseline represents the last visit before the start of therapy with DTG+3TC.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ES, which includes all participants from the FAS except those excluded for various reasons, such as protocol violations and participant withdrawal. As per protocol, data for this outcome measure were analyzed separately for ART-naive and Pre-treated participants, as the variable required different and/or additional response options depending on prior treatment status.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Treatment Switch Due to Virologic Reasons or Due to Intolerability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '335', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ART-naive Participants', 'description': 'Antiretroviral treatment (ART) naïve HIV-1 positive participants for whom DTG+3TC is indicated according to local label.'}, {'id': 'OG001', 'title': 'Pre-treated Participants', 'description': 'Pre-treated HIV-1 positive participants for whom DTG+3TC is indicated according to local label.'}], 'classes': [{'title': 'Virologic reasons', 'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000'}, {'value': '1.5', 'groupId': 'OG001'}]}]}, {'title': 'Intolerability', 'categories': [{'measurements': [{'value': '9.7', 'groupId': 'OG000'}, {'value': '3.6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline until Year 3', 'description': 'The intolerability was determined at the discretion of the physician. Baseline represents the last visit before the start of therapy with DTG+3TC.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ES, which includes all participants from the FAS except those excluded for various reasons, such as protocol violations and participant withdrawal. As per protocol, data for this outcome measure were analyzed separately for ART-naive and Pre-treated participants, as the variable required different and/or additional response options depending on prior treatment status.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Missed Monthly Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '228', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Participants', 'description': 'Antiretroviral treatment (ART) naïve and pre-treated HIV-1 positive participants for whom DTG+3TC is indicated according to local label.'}], 'classes': [{'title': 'At Year 1 - 0-2 missed doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}]}]}, {'title': 'At Year 1 - 3-4 Missed doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '228', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'At Year 1 - 5-6 Missed doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'At Year 1 - >6 Missed doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'At Year 2 - 0-2 missed doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000'}]}]}, {'title': 'At Year 2 - 3-4 Missed doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'At Year 2 - 5-6 Missed doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'At Year 2 - >6 Missed doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'At Year 3 - 0-2 missed doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '228', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000'}]}]}, {'title': 'At Year 3 - 3-4 Missed doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'At Year 3 - 5-6 Missed doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '228', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'At Year 3 - >6 Missed doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '228', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At years 1, 2 and 3', 'description': 'Participants were prompted to give an estimate of their level of adherence in a single-item question part of their self-assessment questionnaires. 0-2 missed doses, 3-4 missed doses, 5-6 missed doses, and \\>6 missed doses were reported.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ES, which includes all participants from the FAS except those excluded for various reasons, such as protocol violations and participant withdrawal.'}, {'type': 'SECONDARY', 'title': 'Number of Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '337', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ART-naive Participants', 'description': 'Antiretroviral treatment (ART) naïve HIV-1 positive participants for whom DTG+3TC is indicated according to local label.'}, {'id': 'OG001', 'title': 'Pre-treated Participants', 'description': 'Pre-treated HIV-1 positive participants for whom DTG+3TC is indicated according to local label.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline until Year 3', 'description': 'An adverse event was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with the treatment. A SAE is any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant.\n\nBaseline represents the last visit before the start of therapy with DTG+3TC.', 'unitOfMeasure': 'Count of events', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Safety Analysis Set, which includes all ES participants who received at least one dose, plus those excluded from ES due to withdrawal but with available safety data. As per protocol, data for this outcome measure were analyzed separately for ART-naive and Pre-treated participants, as the variable required different and/or additional response options depending on prior treatment status.'}, {'type': 'SECONDARY', 'title': 'Frequency of Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '337', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ART-naive Participants', 'description': 'Antiretroviral treatment (ART) naïve HIV-1 positive participants for whom DTG+3TC is indicated according to local label.'}, {'id': 'OG001', 'title': 'Pre-treated Participants', 'description': 'Pre-treated HIV-1 positive participants for whom DTG+3TC is indicated according to local label.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.01', 'groupId': 'OG000'}, {'value': '0.09', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline until Year 3', 'description': 'An adverse event was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with the treatment. A SAE is any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant.\n\nBaseline represents the last visit before the start of therapy with DTG+3TC.', 'unitOfMeasure': 'Events per person-years', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Safety Analysis Set, which includes all ES participants who received at least one dose, plus those excluded from ES due to withdrawal but with available safety data. As per protocol, data for this outcome measure were analyzed separately for ART-naive and Pre-treated participants, as the variable required different and/or additional response options depending on prior treatment status.'}, {'type': 'SECONDARY', 'title': 'Number of Serious and Non-serious Adverse Drug Reactions (ADRs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '337', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ART-naive Participants', 'description': 'Antiretroviral treatment (ART) naïve HIV-1 positive participants for whom DTG+3TC is indicated according to local label.'}, {'id': 'OG001', 'title': 'Pre-treated Participants', 'description': 'Pre-treated HIV-1 positive participants for whom DTG+3TC is indicated according to local label.'}], 'classes': [{'title': 'Serious ADRs', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}, {'title': 'Non-serious ADRs', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline until Year 3', 'description': 'An ADR is defined as a noxious and unintended response to a medicinal investigational product related to any dose where at least a reasonable possibility, i.e. the relationship cannot be ruled out. A serious ADR is any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant.\n\nBaseline represents the last visit before the start of therapy with DTG+3TC.', 'unitOfMeasure': 'Count of events', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Safety Analysis Set, which includes all ES participants who received at least one dose, plus those excluded from ES due to withdrawal but with available safety data. As per protocol, data for this outcome measure were analyzed separately for ART-naive and Pre-treated participants, as the variable required different and/or additional response options depending on prior treatment status.'}, {'type': 'SECONDARY', 'title': 'Frequency of Any Adverse Drug Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '337', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ART-naive Participants', 'description': 'Antiretroviral treatment (ART) naïve HIV-1 positive participants for whom DTG+3TC is indicated according to local label.'}, {'id': 'OG001', 'title': 'Pre-treated Participants', 'description': 'Pre-treated HIV-1 positive participants for whom DTG+3TC is indicated according to local label.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.06', 'groupId': 'OG000'}, {'value': '0.03', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline until Year 3', 'description': 'Any = serious and non-serious ADRs. An ADR is defined as a noxious and unintended response to a medicinal investigational product related to any dose where at least a reasonable possibility, i.e. the relationship cannot be ruled out. A serious ADR is any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant.\n\nBaseline represents the last visit before the start of therapy with DTG+3TC.', 'unitOfMeasure': 'events per person-years', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Safety Analysis Set, which includes all ES participants who received at least one dose, plus those excluded from ES due to withdrawal but with available safety data. As per protocol, data for this outcome measure were analyzed separately for ART-naive and Pre-treated participants, as the variable required different and/or additional response options depending on prior treatment status.'}, {'type': 'SECONDARY', 'title': 'Discontinuation Rates Due to Adverse Drug Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '368', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Total Participants', 'description': 'Antiretroviral treatment (ART) naïve and pre-treated HIV-1 positive participants for whom DTG+3TC is indicated according to local label.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline until Year 3', 'description': 'Baseline represents the last visit before the start of therapy with DTG+3TC.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Safety Analysis Set, which includes all ES participants who received at least one dose, plus those excluded from ES due to withdrawal but with available safety data.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With VL > 50 c/mL With Emergent Resistance Mutations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '335', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ART-naive Participants', 'description': 'Antiretroviral treatment (ART) naïve HIV-1 positive participants for whom DTG+3TC is indicated according to local label.'}, {'id': 'OG001', 'title': 'Pre-treated Participants', 'description': 'Pre-treated HIV-1 positive participants for whom DTG+3TC is indicated according to local label.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline until Year 3', 'description': 'Newly identified resistance-associated mutations, including those detected before initiating treatment with DTG+3TC and most recent HIV-RNA levels.\n\nBaseline represents the last visit before the start of therapy with DTG+3TC.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ES, which includes all participants from the FAS except those excluded for various reasons, such as protocol violations and participant withdrawal. As per protocol, data for this outcome measure were analyzed separately for ART-naive and Pre-treated participants, as the variable required different and/or additional response options depending on prior treatment status.'}, {'type': 'SECONDARY', 'title': 'Change in Lipid Laboratory Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '335', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ART-naive Participants', 'description': 'Antiretroviral treatment (ART) naïve HIV-1 positive participants for whom DTG+3TC is indicated according to local label.'}, {'id': 'OG001', 'title': 'Pre-treated Participants', 'description': 'Pre-treated HIV-1 positive participants for whom DTG+3TC is indicated according to local label.'}], 'classes': [{'title': 'At Year 1 - Total cholesterol', 'categories': [{'measurements': [{'value': '13.0', 'groupId': 'OG000', 'lowerLimit': '-2.0', 'upperLimit': '24.0'}, {'value': '-4.0', 'groupId': 'OG001', 'lowerLimit': '-21.0', 'upperLimit': '15.0'}]}]}, {'title': 'At Year 2 - Total cholesterol', 'categories': [{'measurements': [{'value': '-1.0', 'groupId': 'OG000', 'lowerLimit': '-12.0', 'upperLimit': '43.0'}, {'value': '-1.0', 'groupId': 'OG001', 'lowerLimit': '-22.0', 'upperLimit': '14.0'}]}]}, {'title': 'At Year 3 - Total cholesterol', 'categories': [{'measurements': [{'value': '8.5', 'groupId': 'OG000', 'lowerLimit': '-9.0', 'upperLimit': '14.0'}, {'value': '-6.0', 'groupId': 'OG001', 'lowerLimit': '-39.0', 'upperLimit': '14.0'}]}]}, {'title': 'At Year 1 - LDL cholesterol', 'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000', 'lowerLimit': '-10.0', 'upperLimit': '17.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-16.0', 'upperLimit': '16.0'}]}]}, {'title': 'At Year 2 - LDL cholesterol', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '-7.0', 'upperLimit': '27.0'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '-18.0', 'upperLimit': '20.0'}]}]}, {'title': 'At Year 3 - LDL cholesterol', 'categories': [{'measurements': [{'value': '8.5', 'groupId': 'OG000', 'lowerLimit': '-16.5', 'upperLimit': '19.5'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-28.0', 'upperLimit': '17.4'}]}]}, {'title': 'At Year 1 - HDL cholesterol', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '-3.0', 'upperLimit': '5.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-5.0', 'upperLimit': '4.0'}]}]}, {'title': 'At Year 2 - HDL cholesterol', 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '-2.0', 'upperLimit': '5.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-4.0', 'upperLimit': '5.0'}]}]}, {'title': 'At Year 3 - HDL cholesterol', 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '-4.0', 'upperLimit': '8.0'}, {'value': '-1.0', 'groupId': 'OG001', 'lowerLimit': '-6.0', 'upperLimit': '4.0'}]}]}, {'title': 'At Year 1 - Triglycerides', 'categories': [{'measurements': [{'value': '6.0', 'groupId': 'OG000', 'lowerLimit': '-12.0', 'upperLimit': '39.0'}, {'value': '-3.0', 'groupId': 'OG001', 'lowerLimit': '-43.0', 'upperLimit': '34.5'}]}]}, {'title': 'At Year 2 - Triglycerides', 'categories': [{'measurements': [{'value': '14.0', 'groupId': 'OG000', 'lowerLimit': '-18.0', 'upperLimit': '27.0'}, {'value': '-6.5', 'groupId': 'OG001', 'lowerLimit': '-51.0', 'upperLimit': '33.0'}]}]}, {'title': 'At Year 3 - Triglycerides', 'categories': [{'measurements': [{'value': '-16.5', 'groupId': 'OG000', 'lowerLimit': '-69.0', 'upperLimit': '47.0'}, {'value': '-13.0', 'groupId': 'OG001', 'lowerLimit': '-47.0', 'upperLimit': '29.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At years 1, 2 and 3 compared to Baseline', 'description': 'The following lipid parameters are presented: total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, and triglycerides.\n\nBaseline represents the last visit before the start of therapy with DTG+3TC.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ES, which includes all participants from the FAS except those excluded for various reasons, such as protocol violations and participant withdrawal. As per protocol, data for this outcome measure were analyzed separately for ART-naive and Pre-treated participants, as the variable required different and/or additional response options depending on prior treatment status.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Reasons for Therapy Switch to DTG+3TC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '335', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-treated Participants', 'description': 'Pre-treated HIV-1 positive participants for whom DTG+3TC is indicated according to local label.'}], 'classes': [{'title': 'Side effects of previous ART', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}]}]}, {'title': 'Low potential for interaction', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Preference of a 2-drug regime', 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}]}]}, {'title': 'Tolerability profile of DTG+/3TC', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}, {'title': 'Pill size', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Easy to take (once daily, independent of meals)', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}, {'title': "Patient's preference", 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Baseline', 'description': "The primary reasons for therapy switch are side effects of previous ART, low potential for interaction, preference of a 2-drug regime, tolerability profile of DTG+3TC, pill size, easy to take (once daily, independent of meals), patient's preference, and other.\n\nBaseline represents the last visit before the start of therapy with DTG+3TC.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ES, which includes all participants from the FAS except those excluded for various reasons, such as protocol violations and participant withdrawal. Only Pre-treated participants were included, as the instrument presents the reasons for therapy switch, which requires a previous regimen before DTG + 3TC.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Reasons for DTG+3TC Therapy Initiation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ART-naive Participants', 'description': 'Antiretroviral treatment (ART) naïve HIV-1 positive participants for whom DTG+3TC is indicated according to local label.'}], 'classes': [{'title': 'Low potential for interaction', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Preference of a 2-drug regime', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}]}]}, {'title': 'Prevention of potential long-term toxicities of other therapies', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Tolerability profile of DTG+/3TC', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Easy to take (once daily, independent of meals)', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Baseline', 'description': 'The primary reasons for therapy switch are low potential for interaction, preference of a 2-drug regime, prevention of potential long-term toxicities of other therapies, tolerability profile of DTG+3TC, easy to take (once daily, independent of meals), and other.\n\nBaseline represents the last visit before the start of therapy with DTG+3TC.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ES, which includes all participants from the FAS except those excluded for various reasons, such as protocol violations and participant withdrawal. Only ART-naive participants were included, as the instrument presents the reasons for therapy initiation, which requires no previous regimen before DTG + 3TC.'}, {'type': 'SECONDARY', 'title': 'Change in Treatment Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-treated Participants', 'description': 'Pre-treated HIV-1 positive participants for whom DTG+3TC is indicated according to local label.'}], 'classes': [{'title': 'At Year 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '6.0'}]}]}, {'title': 'At Year 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '5.0'}]}]}, {'title': 'At Year 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '-1.0', 'upperLimit': '5.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At years 1, 2 and 3 compared to Baseline', 'description': 'The change in treatment satisfaction is based on the HIV Treatment Satisfaction questionnaire (HIV TSQ). The HIV TSQ is a 10-item-self-reported scale that measures overall satisfaction with treatment and by specific domains e.g., convenience and flexibility. In treatment satisfaction score ranges from 0-60, where higher the score, greater the satisfaction with treatment. Individual item scores which included All rate score ranging from 0 (very dissatisfied, inconvenient, inflexible) to 6 (very satisfied, convenient, flexible), in case of general satisfaction, there will be 10 items which will be summed to produce a score ranging from 0 to 30, with higher the score greater the satisfaction with subscale. For lifestyle scale with 8 items which will be summed to produce a score ranging from 0 to 30, with higher the score greater the satisfaction with subscale.\n\nBaseline represents the last visit before the start of therapy with DTG+3TC.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ES, including all FAS participants except those excluded for reasons such as protocol violations or withdrawal. Only Pre-treated participants were included, as the instrument compares to prior treatment, which requires a previous regimen before DTG + 3TC. Only those who completed the HIV TSQ at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change in Symptom Distress', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ART-naive Participants', 'description': 'Antiretroviral treatment (ART) naïve HIV-1 positive participants for whom DTG+3TC is indicated according to local label.'}, {'id': 'OG001', 'title': 'Pre-treated Participants', 'description': 'Pre-treated HIV-1 positive participants for whom DTG+3TC is indicated according to local label.'}], 'classes': [{'title': 'At Year 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.0', 'groupId': 'OG000', 'lowerLimit': '-9.0', 'upperLimit': '2.0'}, {'value': '-2.0', 'groupId': 'OG001', 'lowerLimit': '-7.0', 'upperLimit': '2.0'}]}]}, {'title': 'At Year 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '-3.0', 'upperLimit': '6.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-6.0', 'upperLimit': '5.0'}]}]}, {'title': 'At Year 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'groupId': 'OG000', 'lowerLimit': '-6.0', 'upperLimit': '1.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-5.0', 'upperLimit': '5.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At years 1, 2 and 3 compared to Baseline', 'description': 'The change in symptom distress is based on the HIV Symptom Distress Module (SDM) questionnaire. The SDM is a 20-item self-reported tool that assesses the presence and distress of symptoms related to HIV or its treatment. It includes sub-scales for treatment satisfaction and individual satisfaction with treatment changes. The treatment satisfaction score sums all items, ranging from +30 (greater improvement) to -30 (greater deterioration). Individual item scores range from +3 (much more satisfied, convenient, flexible) to -3 (much less satisfied, convenient, flexible). General satisfaction and lifestyle scores sum all items, ranging from +15 (greater improvement) to -15 (greater deterioration).\n\nBaseline represents the last visit before the start of therapy with DTG+3TC.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ES, which includes all participants from the FAS except those excluded for various reasons, such as protocol violations or withdrawal. As per protocol, data for this outcome measure were analyzed separately for ART-naive and Pre-treated participants, as the variable required different and/or additional response options depending on prior treatment status. Only participants who completed the HIV SDM questionnaire at the specified time points, were analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of HIV-RNA Monitoring Measures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '335', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ART-naive Participants', 'description': 'Antiretroviral treatment (ART) naïve HIV-1 positive participants for whom DTG+3TC is indicated according to local label.'}, {'id': 'OG001', 'title': 'Pre-treated Participants', 'description': 'Pre-treated HIV-1 positive participants for whom DTG+3TC is indicated according to local label.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '3.5', 'upperLimit': '4.2'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '3.5', 'upperLimit': '4.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From Baseline until Year 3', 'description': 'Baseline represents the last visit before the start of therapy with DTG+3TC.', 'unitOfMeasure': 'measurements/year', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ES, which includes all participants from the FAS except those excluded for various reasons, such as protocol violations and participant withdrawal. As per protocol, data for this outcome measure were analyzed separately for ART-naive and Pre-treated participants, as the variable required different and/or additional response options depending on prior treatment status.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Referred to Another Medical Specialist', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '335', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ART-naive Participants', 'description': 'Antiretroviral treatment (ART) naïve HIV-1 positive participants for whom DTG+3TC is indicated according to local label.'}, {'id': 'OG001', 'title': 'Pre-treated Participants', 'description': 'Pre-treated HIV-1 positive participants for whom DTG+3TC is indicated according to local label.'}], 'classes': [{'categories': [{'measurements': [{'value': '38.7', 'groupId': 'OG000'}, {'value': '71.6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline until Year 3', 'description': 'Baseline represents the last visit before the start of therapy with DTG+3TC.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the ES, which includes all participants from the FAS except those excluded for various reasons, such as protocol violations and participant withdrawal. As per protocol, data for this outcome measure were analyzed separately for ART-naive and Pre-treated participants, as the variable required different and/or additional response options depending on prior treatment status.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Sustained Virologic Suppression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '335', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ART-naive Participants', 'description': 'Antiretroviral treatment (ART) naïve HIV-1 positive participants for whom DTG+3TC is indicated according to local label.'}, {'id': 'OG001', 'title': 'Pre-treated Participants', 'description': 'Pre-treated HIV-1 positive participants for whom DTG+3TC is indicated according to local label.'}], 'classes': [{'title': 'HIV-RNA <50 c/mL', 'categories': [{'measurements': [{'value': '67.7', 'groupId': 'OG000'}, {'value': '75.5', 'groupId': 'OG001'}]}]}, {'title': 'HIV-RNA 50-200 c/mL & subsequent measurement <50 c/mL', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Year 3', 'description': 'Virologic suppression is defined as a viral load (VL) less than (\\<) 50 copies (c)/mL or, if between 50-200 c/mL, with a subsequent next available measurement \\<50 c/mL (within 120 days).', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Effectiveness Set (ES) which includes all participants from the Full Analysis Set (FAS) except those excluded for various reasons, such as protocol violations and participant withdrawal. As per protocol, data for this outcome measure were analyzed separately for ART-naive and Pre-treated participants, as the variable required different and/or additional response options depending on prior treatment status.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Total Participants', 'description': 'Antiretroviral treatment (ART) naïve and pre-treated HIV-1 positive participants for whom DTG+3TC is indicated according to local label.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Safety Analysis Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '368'}]}, {'type': 'Effectiveness Analysis Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '366'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '366'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Under EU privacy laws, participants who withdraw consent can choose whether their data up to withdrawal may be used or must be deleted. Safety data (e.g., ADRs, SAEs) are exempt and must be retained. This resulted in a higher number of participants analyzed for the Safety Analysis Set (N = 368) compared to Effectiveness Analysis Set (N = 366).', 'preAssignmentDetails': 'A total of 376 participants were enrolled in the Full Analysis Set, of which 10 were excluded for various reasons, including protocol violations and participant withdrawal. The remaining 366 participants were included in the Effectiveness Analysis Set.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '366', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Total Participants', 'description': 'Antiretroviral treatment (ART) naïve and pre-treated HIV-1 positive participants for whom DTG+3TC is indicated according to local label.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '366', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '47.0', 'groupId': 'BG000', 'lowerLimit': '38.0', 'upperLimit': '54.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Male', 'denoms': [{'units': 'Participants', 'counts': [{'value': '366', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '341', 'groupId': 'BG000'}]}]}, {'title': 'Female', 'denoms': [{'units': 'Participants', 'counts': [{'value': '366', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}], 'populationDescription': 'The Baseline analysis was performed on the Effectiveness Set which includes all participants from the Full Analysis Set except those excluded for various reasons, such as protocol violations and participant withdrawal.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-06-15', 'size': 1475477, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-06-16T10:29', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 376}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-05-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-30', 'studyFirstSubmitDate': '2018-10-11', 'resultsFirstSubmitDate': '2025-05-06', 'studyFirstSubmitQcDate': '2018-11-26', 'lastUpdatePostDateStruct': {'date': '2025-08-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-07-30', 'studyFirstPostDateStruct': {'date': '2018-11-27', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Sustained Virologic Suppression', 'timeFrame': 'At Year 3', 'description': 'Virologic suppression is defined as a viral load (VL) less than (\\<) 50 copies (c)/mL or, if between 50-200 c/mL, with a subsequent next available measurement \\<50 c/mL (within 120 days).'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Low Level Viremia', 'timeFrame': 'At Month 6 and years 1, 2 and 3', 'description': 'Low level viremia is defined as a VL measurement greater than (\\>) 50 - \\<200 c/mL for pre-treated participants. For naive participants, a VL measurement between \\>50 to \\<200 c/mL after initial suppression of \\<50 c/mL was evaluated.'}, {'measure': 'Percentage of Participants With Virologic Rebound', 'timeFrame': 'From Baseline until Year 3', 'description': 'Virologic rebound is defined as 2 consecutive VL measurements \\>=200 c/mL after suppression. Baseline represents the last visit before the start of therapy with DTG+3TC.'}, {'measure': 'Percentage of Participants With Treatment Switch Due to Virologic Reasons or Due to Intolerability', 'timeFrame': 'From Baseline until Year 3', 'description': 'The intolerability was determined at the discretion of the physician. Baseline represents the last visit before the start of therapy with DTG+3TC.'}, {'measure': 'Percentage of Participants With Missed Monthly Doses', 'timeFrame': 'At years 1, 2 and 3', 'description': 'Participants were prompted to give an estimate of their level of adherence in a single-item question part of their self-assessment questionnaires. 0-2 missed doses, 3-4 missed doses, 5-6 missed doses, and \\>6 missed doses were reported.'}, {'measure': 'Number of Serious Adverse Events (SAEs)', 'timeFrame': 'From Baseline until Year 3', 'description': 'An adverse event was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with the treatment. A SAE is any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant.\n\nBaseline represents the last visit before the start of therapy with DTG+3TC.'}, {'measure': 'Frequency of Serious Adverse Events', 'timeFrame': 'From Baseline until Year 3', 'description': 'An adverse event was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with the treatment. A SAE is any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant.\n\nBaseline represents the last visit before the start of therapy with DTG+3TC.'}, {'measure': 'Number of Serious and Non-serious Adverse Drug Reactions (ADRs)', 'timeFrame': 'From Baseline until Year 3', 'description': 'An ADR is defined as a noxious and unintended response to a medicinal investigational product related to any dose where at least a reasonable possibility, i.e. the relationship cannot be ruled out. A serious ADR is any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant.\n\nBaseline represents the last visit before the start of therapy with DTG+3TC.'}, {'measure': 'Frequency of Any Adverse Drug Reactions', 'timeFrame': 'From Baseline until Year 3', 'description': 'Any = serious and non-serious ADRs. An ADR is defined as a noxious and unintended response to a medicinal investigational product related to any dose where at least a reasonable possibility, i.e. the relationship cannot be ruled out. A serious ADR is any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant.\n\nBaseline represents the last visit before the start of therapy with DTG+3TC.'}, {'measure': 'Discontinuation Rates Due to Adverse Drug Reactions', 'timeFrame': 'From Baseline until Year 3', 'description': 'Baseline represents the last visit before the start of therapy with DTG+3TC.'}, {'measure': 'Percentage of Participants With VL > 50 c/mL With Emergent Resistance Mutations', 'timeFrame': 'From Baseline until Year 3', 'description': 'Newly identified resistance-associated mutations, including those detected before initiating treatment with DTG+3TC and most recent HIV-RNA levels.\n\nBaseline represents the last visit before the start of therapy with DTG+3TC.'}, {'measure': 'Change in Lipid Laboratory Values', 'timeFrame': 'At years 1, 2 and 3 compared to Baseline', 'description': 'The following lipid parameters are presented: total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, and triglycerides.\n\nBaseline represents the last visit before the start of therapy with DTG+3TC.'}, {'measure': 'Percentage of Participants With Reasons for Therapy Switch to DTG+3TC', 'timeFrame': 'At Baseline', 'description': "The primary reasons for therapy switch are side effects of previous ART, low potential for interaction, preference of a 2-drug regime, tolerability profile of DTG+3TC, pill size, easy to take (once daily, independent of meals), patient's preference, and other.\n\nBaseline represents the last visit before the start of therapy with DTG+3TC."}, {'measure': 'Percentage of Participants With Reasons for DTG+3TC Therapy Initiation', 'timeFrame': 'At Baseline', 'description': 'The primary reasons for therapy switch are low potential for interaction, preference of a 2-drug regime, prevention of potential long-term toxicities of other therapies, tolerability profile of DTG+3TC, easy to take (once daily, independent of meals), and other.\n\nBaseline represents the last visit before the start of therapy with DTG+3TC.'}, {'measure': 'Change in Treatment Satisfaction', 'timeFrame': 'At years 1, 2 and 3 compared to Baseline', 'description': 'The change in treatment satisfaction is based on the HIV Treatment Satisfaction questionnaire (HIV TSQ). The HIV TSQ is a 10-item-self-reported scale that measures overall satisfaction with treatment and by specific domains e.g., convenience and flexibility. In treatment satisfaction score ranges from 0-60, where higher the score, greater the satisfaction with treatment. Individual item scores which included All rate score ranging from 0 (very dissatisfied, inconvenient, inflexible) to 6 (very satisfied, convenient, flexible), in case of general satisfaction, there will be 10 items which will be summed to produce a score ranging from 0 to 30, with higher the score greater the satisfaction with subscale. For lifestyle scale with 8 items which will be summed to produce a score ranging from 0 to 30, with higher the score greater the satisfaction with subscale.\n\nBaseline represents the last visit before the start of therapy with DTG+3TC.'}, {'measure': 'Change in Symptom Distress', 'timeFrame': 'At years 1, 2 and 3 compared to Baseline', 'description': 'The change in symptom distress is based on the HIV Symptom Distress Module (SDM) questionnaire. The SDM is a 20-item self-reported tool that assesses the presence and distress of symptoms related to HIV or its treatment. It includes sub-scales for treatment satisfaction and individual satisfaction with treatment changes. The treatment satisfaction score sums all items, ranging from +30 (greater improvement) to -30 (greater deterioration). Individual item scores range from +3 (much more satisfied, convenient, flexible) to -3 (much less satisfied, convenient, flexible). General satisfaction and lifestyle scores sum all items, ranging from +15 (greater improvement) to -15 (greater deterioration).\n\nBaseline represents the last visit before the start of therapy with DTG+3TC.'}, {'measure': 'Number of HIV-RNA Monitoring Measures', 'timeFrame': 'From Baseline until Year 3', 'description': 'Baseline represents the last visit before the start of therapy with DTG+3TC.'}, {'measure': 'Percentage of Participants Referred to Another Medical Specialist', 'timeFrame': 'From Baseline until Year 3', 'description': 'Baseline represents the last visit before the start of therapy with DTG+3TC.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dolutegravir', 'Two-drug regimen', 'Human Immunodeficiency Virus', 'HIV Symptom Distress Module', 'Lamivudine', 'HIV treatment satisfaction questionnaire'], 'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'This is a prospective, non-interventional, multi-center study, in participants with clinical indication of Human Immunodeficiency Virus (HIV)-1 infection. The aim of the study was to generate the real world evidence for the use of DTG+3TC in routine clinical care in Germany to supplement data obtained from controlled clinical trials. Treatment naïve and pre-treated HIV-1 positive participants were enrolled in the study. The observation period for the study was 3 years. Data was collected from routine clinical care via electronic data capture (EDC) system.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Treatment naïve and pre-treated HIV-1 positive participants from Germany were included in this study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants \\>= 18 years of age.\n* Participants with documented HIV-1 infection.\n* Prescription of DTG + 3TC was issued independently from entering this study.\n* Participants with the ability to understand informed consent form and other relevant regulatory documents.\n\nExclusion Criteria:\n\n* Any contraindication according to Tivicay or Lamivudine summaries of product characteristics (SmPCs).\n* Participants with VL \\> 500 c/mL.\n* Any antiretroviral therapy for the treatment of HIV-1 in addition to DTG and 3TC or the DTG/3TC fixed dose combination (FDC).\n* Participants with hepatitis B virus (HBV)- coinfection.\n* Participants with current participation in the ongoing non-interventional study TRIUMPH (study number: 202033, NCT number: NCT02342769) or in any interventional clinical trial irrespective of indication.\n* Participants who had previously participated in clinical trials assessing DTG+ 3TC.'}, 'identificationModule': {'nctId': 'NCT03754803', 'acronym': 'URBAN', 'briefTitle': 'Description of Real World Antiviral Effectiveness and Sustainability of the 2-Drug Regimen Dolutegravir + Lamivudine in Untreated and Pre-treated Patients in Routine Clinical Care in Germany', 'organization': {'class': 'INDUSTRY', 'fullName': 'ViiV Healthcare'}, 'officialTitle': 'Description of Real World Antiviral Effectiveness and Sustainability of the 2-Drug Regimen Dolutegravir + Lamivudine in Untreated and Pre-treated Patients in Routine Clinical Care in Germany', 'orgStudyIdInfo': {'id': '208983'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Total participants', 'description': 'Antiretroviral treatment (ART) naïve and pre-treated HIV-1 positive participants for whom DTG+3TC is indicated according to local label.', 'interventionNames': ['Other: HIV symptom distress module (SDM) questionnaire', 'Other: HIV treatment satisfaction questionnaire (TSQ)']}], 'interventions': [{'name': 'HIV symptom distress module (SDM) questionnaire', 'type': 'OTHER', 'description': 'The SDM is a 20-item self-reported measure that addresses the presence and perceived distress linked to symptoms commonly associated with HIV or its treatment.', 'armGroupLabels': ['Total participants']}, {'name': 'HIV treatment satisfaction questionnaire (TSQ)', 'type': 'OTHER', 'description': 'The HIV TSQ is a 10-item-self-reported scale that measures overall satisfaction with treatment and by specific domains e.g., convenience and flexibility.', 'armGroupLabels': ['Total participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52062', 'city': 'Aachen', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}, {'zip': '10243', 'city': 'Berlin', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '10629', 'city': 'Berlin', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '10777', 'city': 'Berlin', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '12163', 'city': 'Berlin', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '14057', 'city': 'Berlin', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '14059', 'city': 'Berlin', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '44787', 'city': 'Bochum', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'zip': '50668', 'city': 'Cologne', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '50674', 'city': 'Cologne', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '20146', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '20246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '68161', 'city': 'Mannheim', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}, {'zip': '80331', 'city': 'München', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '80335', 'city': 'München', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '80336', 'city': 'München', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '49090', 'city': 'Osnabrück', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 52.27264, 'lon': 8.0498}}, {'zip': '99427', 'city': 'Weimar', 'country': 'Germany', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 50.9803, 'lon': 11.32903}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'ViiV Healthcare'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.ViiV-studyregister.com/documents/About\\_ViiV\\_Patient\\_Level\\_Data\\_Sharing\\_Final\\_25Sep2023.pdf.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ViiV Healthcare', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'MUC Research GmbH', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}