Ignite Creation Date:
2025-12-24 @ 3:14 PM
Ignite Modification Date:
2025-12-28 @ 6:10 PM
Study NCT ID:
NCT01568892
Status:
COMPLETED
Last Update Posted:
2018-07-02
First Post:
2012-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study Assessing Dolutegravir in HIV-1 Infected Subjects With Virus Resistant to Raltegravir and/or Elivitegravir
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C562325', 'term': 'dolutegravir'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'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 (SAEs) and non-serious AEs were collected in the time period from the first dose of study medication until early withdrawal or through the Week 48 analysis data cut-off date (median of 55 study weeks).', 'description': 'SAEs and AEs were collected in members of Safety Population, comprised of all randomized participants who received at least one dose of study medication.', 'eventGroups': [{'id': 'EG000', 'title': 'DTG 50mg BID', 'description': 'Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 11, 'seriousNumAtRisk': 14, 'deathsNumAffected': 2, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase', 'description': 'Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 14, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Breast enlargement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Erectile dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Injection site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Libido decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Macule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Mood altered', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nephropathy toxic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Skin irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Thermal burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vaginal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Fungal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Genital herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Helicobacter infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Syphilis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Urethritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Food poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gingival bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Odynophagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Proctalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Rectal fissure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Amnesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nasal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sinus congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Local swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Rash pruritic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Haemorrhagic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Breast pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Ejaculation delayed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pelvic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': "Peyronie's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Excoriation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Squamous cell carcinoma of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cardiac death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Multiple fractures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Brain injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pulmonary contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Perirectal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Change From Baseline in Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) at Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG 50 mg BID', 'description': 'Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.'}, {'id': 'OG001', 'title': 'Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase', 'description': 'Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.06', 'spread': '0.168', 'groupId': 'OG000'}, {'value': '0.10', 'spread': '0.183', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.16', 'ciLowerLimit': '-1.52', 'ciUpperLimit': '-0.80', 'estimateComment': 'The estimated value represents the adjusted mean difference between the two treatment arms.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Day 8', 'description': 'Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline (Day 1) and Day 8. Change from Baseline was calculated as the value at Day 8 minus the value at Baseline (Day 1). The analysis was performed using statistical modeling correcting for Baseline plasma HIV-1 RNA, Baseline Dolutegravir (DTG) fold change (FC), the overall susceptibility score (OSS) of the failing regimen, and the interaction between DTG FC and treatment. Means and differences were calculated using the average Baseline DTG FC of the entire Intent-to-Treat Exposed (ITT-E) Population. The last observation carried forward with discontinuation equals Baseline (LOCFDB) dataset was used for the analysis. For the LOCFDB dataset, missing values were carried forward from the previous, non-missing, available on-treatment assessment, except formissing values due to premature withdrawal or Day 8 missing values, which had the Baseline value imputed.', 'unitOfMeasure': 'Log 10 copies per milliliter (c/mL)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT-E Population: all randomized participants who received at least one dose of study medication. One participant receiving DTG 50 mg BID was excluded from analysis because they had no Baseline DTG FC value.'}, {'type': 'SECONDARY', 'title': 'Absolute Values in Plasma HIV-1 RNA Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG 50 mg BID', 'description': 'Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.'}, {'id': 'OG001', 'title': 'Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase', 'description': 'Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.'}], 'classes': [{'title': 'Baseline, n=14, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.02', 'spread': '0.940', 'groupId': 'OG000'}, {'value': '4.42', 'spread': '0.760', 'groupId': 'OG001'}]}]}, {'title': 'Day 8, n=14, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.95', 'spread': '0.790', 'groupId': 'OG000'}, {'value': '4.39', 'spread': '0.844', 'groupId': 'OG001'}]}]}, {'title': 'Day 28, n=13, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.14', 'spread': '0.772', 'groupId': 'OG000'}, {'value': '2.30', 'spread': '1.054', 'groupId': 'OG001'}]}]}, {'title': 'Week 8, n=11, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.35', 'spread': '0.851', 'groupId': 'OG000'}, {'value': '2.10', 'spread': '0.913', 'groupId': 'OG001'}]}]}, {'title': 'Week 12, n=12, 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.51', 'spread': '1.048', 'groupId': 'OG000'}, {'value': '2.27', 'spread': '1.179', 'groupId': 'OG001'}]}]}, {'title': 'Week 16, n=12, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.57', 'spread': '1.093', 'groupId': 'OG000'}, {'value': '2.18', 'spread': '1.098', 'groupId': 'OG001'}]}]}, {'title': 'Week 24, n=11, 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.65', 'spread': '1.219', 'groupId': 'OG000'}, {'value': '1.88', 'spread': '0.654', 'groupId': 'OG001'}]}]}, {'title': 'Week 32, n=11, 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.72', 'spread': '1.176', 'groupId': 'OG000'}, {'value': '1.81', 'spread': '0.664', 'groupId': 'OG001'}]}]}, {'title': 'Week 40, n=7, 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.35', 'spread': '1.169', 'groupId': 'OG000'}, {'value': '1.68', 'spread': '0.133', 'groupId': 'OG001'}]}]}, {'title': 'Week 48, n=8, 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.47', 'spread': '1.037', 'groupId': 'OG000'}, {'value': '1.62', 'spread': '0.088', 'groupId': 'OG001'}]}]}, {'title': 'Week 60, n=5, 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.15', 'spread': '1.013', 'groupId': 'OG000'}, {'value': '1.67', 'spread': '0.150', 'groupId': 'OG001'}]}]}, {'title': 'Week 72, n=3, 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.35', 'spread': '1.312', 'groupId': 'OG000'}, {'value': '1.62', 'spread': '0.054', 'groupId': 'OG001'}]}]}, {'title': 'Week 84, n=0, 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.59', 'spread': 'NA', 'comment': 'Only one participant was analyzed for this treatment arm at this time point; thus, no standard deviation could be calculated for this single participant.', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Day 8; Day 28; Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72, and 84', 'description': 'Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline (Day 1), Day 8, Day 28, Week 8, Week 12, Week 16, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, and Week 84. NA indicates data was not available.', 'unitOfMeasure': 'Log10 c/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT-E Population. The Observed Case dataset, in which only the data that are available at a particular time point are used, with no imputation for missing values, was used for analysis. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Plasma HIV-1 RNA Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG 50 mg BID', 'description': 'Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.'}, {'id': 'OG001', 'title': 'Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase', 'description': 'Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.'}], 'classes': [{'title': 'Baseline, n=14, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.02', 'spread': '0.940', 'groupId': 'OG000'}, {'value': '4.42', 'spread': '0.760', 'groupId': 'OG001'}]}]}, {'title': 'Day 8, n=14, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.07', 'spread': '0.683', 'groupId': 'OG000'}, {'value': '-0.03', 'spread': '0.262', 'groupId': 'OG001'}]}]}, {'title': 'Day 28, n=13, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.87', 'spread': '0.898', 'groupId': 'OG000'}, {'value': '-2.12', 'spread': '1.111', 'groupId': 'OG001'}]}]}, {'title': 'Week 8, n=11, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.89', 'spread': '0.890', 'groupId': 'OG000'}, {'value': '-2.32', 'spread': '1.112', 'groupId': 'OG001'}]}]}, {'title': 'Week 12, n=12, 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.54', 'spread': '1.022', 'groupId': 'OG000'}, {'value': '-2.02', 'spread': '1.245', 'groupId': 'OG001'}]}]}, {'title': 'Week 16, n=12, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.48', 'spread': '1.101', 'groupId': 'OG000'}, {'value': '-2.24', 'spread': '1.180', 'groupId': 'OG001'}]}]}, {'title': 'Week 24, n=11, 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.38', 'spread': '1.151', 'groupId': 'OG000'}, {'value': '-2.53', 'spread': '1.033', 'groupId': 'OG001'}]}]}, {'title': 'Week 32, n=11, 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.31', 'spread': '1.059', 'groupId': 'OG000'}, {'value': '-2.62', 'spread': '0.931', 'groupId': 'OG001'}]}]}, {'title': 'Week 40, n=7, 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.48', 'spread': '1.445', 'groupId': 'OG000'}, {'value': '-2.70', 'spread': '0.843', 'groupId': 'OG001'}]}]}, {'title': 'Week 48, n=8, 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.34', 'spread': '1.235', 'groupId': 'OG000'}, {'value': '-2.77', 'spread': '0.881', 'groupId': 'OG001'}]}]}, {'title': 'Week 60, n=5, 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.91', 'spread': '1.400', 'groupId': 'OG000'}, {'value': '-2.71', 'spread': '0.863', 'groupId': 'OG001'}]}]}, {'title': 'Week 72, n=3, 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.08', 'spread': '1.311', 'groupId': 'OG000'}, {'value': '-3.31', 'spread': '0.968', 'groupId': 'OG001'}]}]}, {'title': 'Week 84, n=0, 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.75', 'spread': 'NA', 'comment': 'Only one participant was analyzed for this treatment arm at this time point; thus, no standard deviation could be calculated for this single participant.', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Day 8; Day 28; Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72, and 84', 'description': 'Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline (Day 1), Day 8, Day 28, Week 8, Week 12, Week 16, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, and Week 84. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. NA indicates data was not available.', 'unitOfMeasure': 'Log10 c/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT-E Population. The Observed Case dataset, in which only the data that are available at the particular time point are used, with no imputation for missing values, was used for analysis. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Plasma HIV-1 RNA <50 c/mL Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG 50 mg BID', 'description': 'Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.'}, {'id': 'OG001', 'title': 'Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase', 'description': 'Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 28', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Week 32', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Week 40', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline; Day 8; Day 28; Weeks 8, 12, 16, 24, 32, 40 and 48', 'description': "Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline (Day 1); Day 8; Day 28; Weeks 8, 12, 16, 24, 32, 40, and 48. Number of participants with plasma HIV-1 RNA level \\<50 c/mL was obtained using Food and Drug Administration's (FDA's) snapshot algorithm, where all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) were treated as non-responders. Also, participants who switched their concomitant antiretroviral therapy (ART) prior to the visit of interest as follows were also treated as non-responders: background ART substitutions not permitted per protocol; background ART substitutions permitted per protocol; however, the decision to switch is not documented as being before or at the first On-treatment visit after switching to optimized background regimen (OBR) (i.e. Day 28) where HIV-1 RNA is assessed.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT-E Population. The Snapshot dataset was used for analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Plasma HIV-1 RNA <400 c/mL Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG 50 mg BID', 'description': 'Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.'}, {'id': 'OG001', 'title': 'Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase', 'description': 'Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 8', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Day 28', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Week 32', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Week 40', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline; Day 8; Day 28; Weeks 8, 12, 16, 24, 32, 40 and 48', 'description': "Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline (Day 1); Day 8; Day 28; Weeks 8, 12, 16, 24, 32, 40 and 48. Number of participants with plasma HIV-1 RNA level \\<400 c/mL was obtained using FDA's snapshot algorithm, where all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) were treated as non-responders. Also, participants who switch their concomitant ART prior to the visit of interest as follows were also treated as non-responders: background ART substitutions not permitted per protocol; background ART substitutions permitted per protocol; however the decision to switch is not documented as being before or at the first On-treatment visit after switching to OBR (i.e. Day 28) where HIV-1 RNA is assessed.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT-E Population. The Snapshot dataset was used for analysis.'}, {'type': 'SECONDARY', 'title': 'Absolute Values in Cluster of Differentiation 4+ (CD4+) Cell Counts Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG 50 mg BID', 'description': 'Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.'}, {'id': 'OG001', 'title': 'Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase', 'description': 'Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.'}], 'classes': [{'title': 'Baseline, n=14, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '163.5', 'groupId': 'OG000', 'lowerLimit': '111.0', 'upperLimit': '231.0'}, {'value': '90.5', 'groupId': 'OG001', 'lowerLimit': '46.0', 'upperLimit': '267.5'}]}]}, {'title': 'Day 8, n=14, 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '198.5', 'groupId': 'OG000', 'lowerLimit': '154.0', 'upperLimit': '239.0'}, {'value': '102.0', 'groupId': 'OG001', 'lowerLimit': '50.0', 'upperLimit': '310.0'}]}]}, {'title': 'Day 28, n=13, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '174.0', 'groupId': 'OG000', 'lowerLimit': '168.0', 'upperLimit': '335.0'}, {'value': '234.0', 'groupId': 'OG001', 'lowerLimit': '114.5', 'upperLimit': '303.5'}]}]}, {'title': 'Week 8, n=11, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '211.0', 'groupId': 'OG000', 'lowerLimit': '71.0', 'upperLimit': '401.0'}, {'value': '228.0', 'groupId': 'OG001', 'lowerLimit': '124.0', 'upperLimit': '357.5'}]}]}, {'title': 'Week 12, n=12, 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '223.5', 'groupId': 'OG000', 'lowerLimit': '115.0', 'upperLimit': '345.5'}, {'value': '217.5', 'groupId': 'OG001', 'lowerLimit': '121.0', 'upperLimit': '333.0'}]}]}, {'title': 'Week 16, n=12, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '241.0', 'groupId': 'OG000', 'lowerLimit': '107.5', 'upperLimit': '382.5'}, {'value': '262.5', 'groupId': 'OG001', 'lowerLimit': '132.5', 'upperLimit': '436.5'}]}]}, {'title': 'Week 24, n=11, 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '232.0', 'groupId': 'OG000', 'lowerLimit': '116.0', 'upperLimit': '509.0'}, {'value': '242.0', 'groupId': 'OG001', 'lowerLimit': '194.0', 'upperLimit': '399.0'}]}]}, {'title': 'Week 32, n=11, 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '213.0', 'groupId': 'OG000', 'lowerLimit': '91.0', 'upperLimit': '489.0'}, {'value': '326.0', 'groupId': 'OG001', 'lowerLimit': '229.0', 'upperLimit': '542.0'}]}]}, {'title': 'Week 40, n=8, 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '299.5', 'groupId': 'OG000', 'lowerLimit': '212.5', 'upperLimit': '566.5'}, {'value': '328.0', 'groupId': 'OG001', 'lowerLimit': '204.5', 'upperLimit': '508.0'}]}]}, {'title': 'Week 48, n=8, 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '328.0', 'groupId': 'OG000', 'lowerLimit': '263.0', 'upperLimit': '526.5'}, {'value': '370.0', 'groupId': 'OG001', 'lowerLimit': '231.0', 'upperLimit': '457.0'}]}]}, {'title': 'Week 60, n=5, 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '321.0', 'groupId': 'OG000', 'lowerLimit': '234.0', 'upperLimit': '328.0'}, {'value': '333.0', 'groupId': 'OG001', 'lowerLimit': '217.5', 'upperLimit': '541.0'}]}]}, {'title': 'Week 72, n=3, 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '321.0', 'groupId': 'OG000', 'lowerLimit': '261.0', 'upperLimit': '465.0'}, {'value': '299.5', 'groupId': 'OG001', 'lowerLimit': '231.5', 'upperLimit': '349.0'}]}]}, {'title': 'Week 84, n=0, 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '368.0', 'groupId': 'OG001', 'lowerLimit': '368.0', 'upperLimit': '368.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline; Day 8; Day 28; Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72, and 84', 'description': 'Blood samples were collected for lymphocyte subset assessment by flow cytometry at Baseline; Day 8; Day 28; Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72, and 84.', 'unitOfMeasure': 'Cells per cubic millimeters', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT-E Population. The Observed Case dataset, in which only the data that are available at a particular time point are used, with no imputation for missing values, was used for analysis. Only those participants available at the specified time points were analyzed (represented by n=X in category titles).'}, {'type': 'SECONDARY', 'title': 'Median Change From Baseline in CD4+ Cell Counts Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG 50 mg BID', 'description': 'Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.'}, {'id': 'OG001', 'title': 'Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase', 'description': 'Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.'}], 'classes': [{'title': 'Baseline, n=14, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '163.5', 'groupId': 'OG000', 'lowerLimit': '111.0', 'upperLimit': '231.0'}, {'value': '90.5', 'groupId': 'OG001', 'lowerLimit': '46.0', 'upperLimit': '267.5'}]}]}, {'title': 'Day 8, n=14, 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '94.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '-12.0', 'upperLimit': '24.0'}]}]}, {'title': 'Day 28, n=13, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.0', 'groupId': 'OG000', 'lowerLimit': '6.0', 'upperLimit': '68.0'}, {'value': '68.5', 'groupId': 'OG001', 'lowerLimit': '5.0', 'upperLimit': '140.5'}]}]}, {'title': 'Week 8, n=11, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '34.0', 'groupId': 'OG000', 'lowerLimit': '10.0', 'upperLimit': '96.0'}, {'value': '87.5', 'groupId': 'OG001', 'lowerLimit': '9.5', 'upperLimit': '138.5'}]}]}, {'title': 'Week 12, n=12, 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '49.0', 'groupId': 'OG000', 'lowerLimit': '-5.0', 'upperLimit': '83.0'}, {'value': '79.0', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '121.0'}]}]}, {'title': 'Week 16, n=12, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '76.5', 'groupId': 'OG000', 'lowerLimit': '3.0', 'upperLimit': '151.0'}, {'value': '70.0', 'groupId': 'OG001', 'lowerLimit': '20.5', 'upperLimit': '235.0'}]}]}, {'title': 'Week 24, n=11, 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '39.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '134.0'}, {'value': '117.0', 'groupId': 'OG001', 'lowerLimit': '23.0', 'upperLimit': '163.0'}]}]}, {'title': 'Week 32, n=11, 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '48.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '198.0'}, {'value': '135.5', 'groupId': 'OG001', 'lowerLimit': '58.0', 'upperLimit': '271.0'}]}]}, {'title': 'Week 40, n=8, 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '90.5', 'groupId': 'OG000', 'lowerLimit': '45.0', 'upperLimit': '226.5'}, {'value': '125.5', 'groupId': 'OG001', 'lowerLimit': '50.0', 'upperLimit': '244.5'}]}]}, {'title': 'Week 48, n=8, 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '115.0', 'groupId': 'OG000', 'lowerLimit': '96.0', 'upperLimit': '226.5'}, {'value': '156.0', 'groupId': 'OG001', 'lowerLimit': '68.0', 'upperLimit': '293.0'}]}]}, {'title': 'Week 60, n=5, 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '170.0', 'groupId': 'OG000', 'lowerLimit': '65.0', 'upperLimit': '210.0'}, {'value': '146.0', 'groupId': 'OG001', 'lowerLimit': '73.5', 'upperLimit': '242.0'}]}]}, {'title': 'Week 72, n=3, 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '163.0', 'groupId': 'OG000', 'lowerLimit': '96.0', 'upperLimit': '354.0'}, {'value': '174.0', 'groupId': 'OG001', 'lowerLimit': '147.0', 'upperLimit': '225.0'}]}]}, {'title': 'Week 84, n=0, 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '269.0', 'groupId': 'OG001', 'lowerLimit': '269.0', 'upperLimit': '269.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline; Day 8; Day 28; Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72, and 84', 'description': 'Blood samples were collected for lymphocyte subset assessment by flow cytometry at Baseline; Day 8; Day 28; Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72, and 84. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.', 'unitOfMeasure': 'Cells per cubic millimeters', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT-E Population. Observed dataset was used for analysis. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).'}, {'type': 'SECONDARY', 'title': 'Absolute Values in Cluster of Differentiation 8+ (CD8+) Cell Counts Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG 50 mg BID', 'description': 'Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.'}, {'id': 'OG001', 'title': 'Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase', 'description': 'Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.'}], 'classes': [{'title': 'Baseline, n=14, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '896.0', 'groupId': 'OG000', 'lowerLimit': '589.0', 'upperLimit': '1689.0'}, {'value': '808.5', 'groupId': 'OG001', 'lowerLimit': '436.5', 'upperLimit': '1221.0'}]}]}, {'title': 'Day 28, n=13, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1135.0', 'groupId': 'OG000', 'lowerLimit': '598.0', 'upperLimit': '1741.0'}, {'value': '973.0', 'groupId': 'OG001', 'lowerLimit': '675.0', 'upperLimit': '1322.0'}]}]}, {'title': 'Week 12, n=11, 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1198.0', 'groupId': 'OG000', 'lowerLimit': '591.0', 'upperLimit': '1977.0'}, {'value': '1184.0', 'groupId': 'OG001', 'lowerLimit': '860.0', 'upperLimit': '1711.0'}]}]}, {'title': 'Week 24, n=11, 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1160.0', 'groupId': 'OG000', 'lowerLimit': '526.0', 'upperLimit': '1908.0'}, {'value': '1323.0', 'groupId': 'OG001', 'lowerLimit': '969.0', 'upperLimit': '1622.0'}]}]}, {'title': 'Week 48, n=6, 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1295.0', 'groupId': 'OG000', 'lowerLimit': '837.0', 'upperLimit': '1818.0'}, {'value': '1147.0', 'groupId': 'OG001', 'lowerLimit': '753.0', 'upperLimit': '1570.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline; Day 28; Weeks 12, 24, and 48', 'description': 'Blood samples were collected for lymphocyte subset assessment by flow cytometry at Baseline; Day 28; and Weeks 12, 24, and 48.', 'unitOfMeasure': 'Cells per cubic millimeter', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT-E Population. The Observed Case dataset, in which only the data that are available at a particular time point are used, with no imputation for missing values, was used for analysis. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).'}, {'type': 'SECONDARY', 'title': 'Median Change From Baseline in CD8+ Cell Counts Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG 50 mg BID', 'description': 'Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.'}, {'id': 'OG001', 'title': 'Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase', 'description': 'Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.'}], 'classes': [{'title': 'Baseline, n=14, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '896.0', 'groupId': 'OG000', 'lowerLimit': '589.0', 'upperLimit': '1689.0'}, {'value': '808.5', 'groupId': 'OG001', 'lowerLimit': '436.5', 'upperLimit': '1221.0'}]}]}, {'title': 'Day 28, n=13, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '227.0', 'groupId': 'OG000', 'lowerLimit': '-135.0', 'upperLimit': '301.0'}, {'value': '177.0', 'groupId': 'OG001', 'lowerLimit': '51.0', 'upperLimit': '278.5'}]}]}, {'title': 'Week 12, n=11, 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '151.0', 'groupId': 'OG000', 'lowerLimit': '-150.0', 'upperLimit': '379.0'}, {'value': '288.0', 'groupId': 'OG001', 'lowerLimit': '193.0', 'upperLimit': '484.0'}]}]}, {'title': 'Week 24, n=11, 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '79.0', 'groupId': 'OG000', 'lowerLimit': '-183.0', 'upperLimit': '269.0'}, {'value': '543.0', 'groupId': 'OG001', 'lowerLimit': '35.0', 'upperLimit': '930.0'}]}]}, {'title': 'Week 48, n=6, 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '88.0', 'groupId': 'OG000', 'lowerLimit': '-19.0', 'upperLimit': '179.0'}, {'value': '124.0', 'groupId': 'OG001', 'lowerLimit': '-102.5', 'upperLimit': '238.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline; Day 28; Weeks 12, 24, and 48', 'description': 'Blood samples were collected for lymphocyte subset assessment by flow cytometry at Baseline; Day 28; and Weeks 12, 24, and 48. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.', 'unitOfMeasure': 'Cells per cubic millimeter', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT-E Population. The Observed Case dataset, in which only the data that are available at a particular time point are used, with no imputation for missing values, was used for analysis. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With the Indicated Type of HIV-1 Disease Progression (Acquired Immunodeficiency Syndrome [AIDS] or Death [DT])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG 50 mg BID', 'description': 'Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.'}, {'id': 'OG001', 'title': 'Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase', 'description': 'Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.'}], 'classes': [{'title': 'From CDC Class A to CDC Class C', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'From CDC Class B to CDC Class C', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'From CDC Class C to new CDC Class C', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'From CDC Class A, B, or C to Death', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the day of the first dose of study drug until early withdrawal or the Week 48 analysis cut-off date (median of 55 study weeks)', 'description': 'The number of participants with HIV-1 disease progression (AIDS or death) was assessed per the Centers for Disease Control and Prevention (CDC) 1993 revised classification system for HIV infection and expanded surveillance case definition for AIDS among adolescents and adults. The CDC classifies HIV infection as Category A (participants with asymptomatic HIV infection, acute HIV infection with accompanying illness, or persistent generalized lymphadenopathy), Category B (participants with symptomatic non-AIDS condition, i.e., conditions that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or conditions are considered by physicians to have a clinical course or to require management that is complicated by HIV infection), and Category C (includes AIDS indicator conditions as defined by diagnostic or presumptive measures).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT-E Population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Any Adverse Event (Serious and Non-serious) of the Indicated Grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG 50 mg BID', 'description': 'Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.'}, {'id': 'OG001', 'title': 'Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase', 'description': 'Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.'}], 'classes': [{'title': 'Grade 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Grade 2', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Grade 4', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the first dose of study medication until early withdrawal or through the Week 48 analysis data cut-off date (median of 55 study weeks)', 'description': 'An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as 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. Medical or scientific judgment should be exercised in other situations. Adverse events were graded for severity according to the Division of AIDS (DAIDS) toxicity scales as: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), or Grade 4 (potentially life threatening).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population: all randomized participants who received at least one dose of study medication'}, {'type': 'SECONDARY', 'title': 'Number of Participants With the Maximum Post-Baseline-emergent Clinical Chemistry Toxicities of the Indicated Grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG 50 mg BID', 'description': 'Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.'}, {'id': 'OG001', 'title': 'Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase', 'description': 'Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.'}], 'classes': [{'title': 'Grade 1', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Grade 2', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the first dose of study medication until early withdrawal or through the Week 48 analysis data cut-off date (median of 55 study weeks)', 'description': 'Participants with post-Baseline-emergent clinical chemistry toxicities were analyzed. Clinical chemistry toxicities were graded for severity according to the DAIDS toxicity scales as: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), or Grade 4 (potentially life threatening).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With the Maximum Post-Baseline-emergent Hematology Toxicities of the Indicated Grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG 50 mg BID', 'description': 'Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.'}, {'id': 'OG001', 'title': 'Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase', 'description': 'Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.'}], 'classes': [{'title': 'Grade 1', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Grade 2', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the first dose of study medication until early withdrawal or through the Week 48 analysis data cut-off date (median of 55 study weeks)', 'description': 'Participants with post-Baseline-emergent hematology toxicities were analyzed. Hematology toxicities were graded for severity according to the DAIDS toxicity scales as: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), or Grade 4 (potentially life threatening).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'AUC(0-tau) of DTG', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall Study Arm', 'description': 'All the participants who received DTG 50 mg BID.'}], 'classes': [{'categories': [{'measurements': [{'value': '37.9', 'spread': '41.8', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 8, Day 28, and Week 24', 'description': 'The area under the time concentration curve over the dosing interval (AUC\\[0-tau\\]) of DTG was assessed by a population pharmacokinetic (PK) modeling approach using pooled DTG PK data from multiple studies. Blood samples for the determination of plasma DTG concentration were collected at the following time points: pre-dose and 1-3 hours post-dose on Day 8; pre-dose and within a post-dose window (1-3 hours or 4-12 hours) on Day 28 and Week 24. For Day 8 PK, only samples collected from participants randomized to the active DTG arm were analyzed.', 'unitOfMeasure': 'µg*hour per mL (µg*hr/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK concentration Population comprised of all participants who received DTG, underwent PK sampling during the study, and provided evaluable DTG plasma concentration data.'}, {'type': 'SECONDARY', 'title': 'Cmax of DTG', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall Study Arm', 'description': 'All the participants who received DTG 50 mg BID.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.14', 'spread': '32.6', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 8, Day 28, and Week 24', 'description': 'The maximal concentration (Cmax) of DTG was assessed by a population PK modeling approach using pooled DTG PK data from multiple studies. Blood samples for the determination of plasma DTG concentration were collected at the following time points: pre-dose and 1-3 hours post-dose on Day 8; pre-dose and within a post-dose window (1-3 hours or 4-12 hours) on Day 28 and Week 24. For Day 8 PK, only samples collected from participants randomized to the active DTG arm were analyzed.', 'unitOfMeasure': 'Micrograms per milliliter (µg/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK concentration Population comprised of all participants who received DTG, underwent PK sampling during the study, and provided evaluable DTG plasma concentration data.'}, {'type': 'SECONDARY', 'title': 'Plasma DTG Pre-dose Concentration (C0) at Day 8, Day 28, and Week 24; and Average DTG C0 (C0 Avg) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG 50 mg BID', 'description': 'Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.'}, {'id': 'OG001', 'title': 'Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase', 'description': 'Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.'}], 'classes': [{'title': 'Day 8 C0, n=10, 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.043', 'spread': '44', 'groupId': 'OG000'}]}]}, {'title': 'Day 28 C0, n=11, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.393', 'spread': '189', 'groupId': 'OG000'}, {'value': '2.154', 'spread': '81', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 C0, n=10, 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.864', 'spread': '110', 'groupId': 'OG000'}, {'value': '2.201', 'spread': '145', 'groupId': 'OG001'}]}]}, {'title': 'C0_avg, n=13, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.820', 'spread': '188', 'groupId': 'OG000'}, {'value': '2.307', 'spread': '76', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 8, Day 28, and Week 24', 'description': 'Blood samples for the determination of plasma DTG pre-dose concentration were collected pre-dose on Day 8, Day 28, and Week 24. For Day 8 PK, only samples collected from participants randomized to the active DTG arm were analyzed. C0 Avg was calculated at Week 24 as the mean of the concentration at Day 8, Day 28, and Week 24.', 'unitOfMeasure': 'µg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Parameter Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PK Parameter Population.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Defined Virologic Failure (PDVF), as a Measure of Genotypic Resistance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG 50 mg BID', 'description': 'Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.'}, {'id': 'OG001', 'title': 'Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase', 'description': 'Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.'}], 'classes': [{'title': 'Any integrase mutation', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'L74L/M', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'T97A', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'E138E/K', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'E138K', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'S147G', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'N155N/H', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the first dose of study medication until early withdrawal or through the Week 48 analysis data cut-off date (median of 55 study weeks)', 'description': 'For participants meeting one of the criteria for PDVF, plasma samples collected at the time point of virologic failure were tested to evaluate any potential genotypic and/or phenotypic evolution of resistance. PDVF was defined as (A) Virologic Non-response: a decrease in plasma HIV-1 RNA of \\<1 log10 copies/mL by Day 28, with subsequent confirmation, unless plasma HIV-1 RNA is \\<400 copies/mL; confirmed plasma HIV-1 RNA levels \\>=400 copies/mL on or after Week 24 or (B) Virologic Rebound: confirmed rebound in plasma HIV-1 RNA levels to \\>=400 copies/mL after prior confirmed suppression to \\<400 copies/mL; confirmed plasma HIV-1 RNA levels \\>1 log10 copies/mL above the nadir value, where nadir is \\>=400 copies/mL.Treatment-emergent IN mutations are those detected at the time of PDVF but not at Baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PDVF Genotypic/Phenotypic Population: all participants in the ITT-E population with protocol-defined virologic failure. Only participants with Baseline integrase mutations with PDVF who had paired Baseline and time of PDVF samples were considered for analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With the Indicated Fold Increase in Fold Change (FC) in the 50% Inhibitory Concentration Relative to Wild-type Virus for DTG (i.e. PDVF FC/Baseline FC Ratio) at the Time of PDVF, as a Measure of Phenotypic Resistance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG 50 mg BID', 'description': 'Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.'}, {'id': 'OG001', 'title': 'Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase', 'description': 'Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.'}], 'classes': [{'title': '4-<8 fold increase in DTG FC', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '>=8 fold increase in DTG FC', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the first dose of study medication until early withdrawal or through the Week 48 analysis data cut-off date (median of 55 study weeks)', 'description': 'For participants meeting one of the criteria for PDVF, plasma samples collected at the time point of virologic failure were tested to evaluate any potential genotypic and/or phenotypic evolution of resistance. The FC in IC50 (50% inhibitory concentration) for DTG relative to wild-type virus was determined for virus isolated at Baseline and at the time of PDVF. The number of participants with the indicated change (ratio) in the two values at the time of PDVF is presented. PDVF was defined as (A) Virologic Non-response: a decrease in plasma HIV-1 RNA of \\<1 log10 copies/mL by Day 28, with subsequent confirmation, unless plasma HIV-1 RNA is \\<400 copies/mL; confirmed plasma HIV-1 RNA levels \\>=400 copies/mL on or after Week 24 or (B) Virologic Rebound: confirmed rebound in plasma HIV-1 RNA levels to \\>=400 copies/mL after prior confirmed suppression to \\<400 copies/mL; confirmed plasma HIV-1 RNA levels \\>1 log10 copies/mL above the nadir value, where nadir is \\>=400 copies/mL.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PDVF Genotypic/Phenotypic Population: all participants in the ITT-E population with protocol-defined virologic failure. Only participants with Baseline integrase mutations with PDVF who had paired Baseline and time of PDVF samples were considered for analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Discontinued Study Treatment Due to AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG 50 mg BID', 'description': 'Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.'}, {'id': 'OG001', 'title': 'Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase', 'description': 'Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the first dose of study medication until early withdrawal or through the Week 48 analysis data cut-off date (median of 55 study weeks)', 'description': 'The number of participants who permanently discontinued study treatment due to AEs is presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG 50 mg BID', 'description': 'Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.'}, {'id': 'OG001', 'title': 'Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase', 'description': 'Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 24', 'description': 'Twelve lead ECG was performed using an automated ECG machine. The number of participants with abnormal-clinically significant ECG findings at any time on-treatment is reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants with data available at the specified time point was analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG 50 mg BID', 'description': 'Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.'}, {'id': 'OG001', 'title': 'Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase', 'description': 'Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.'}], 'classes': [{'title': 'SBP; Baseline; n=14, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '120.4', 'spread': '15.60', 'groupId': 'OG000'}, {'value': '113.4', 'spread': '9.99', 'groupId': 'OG001'}]}]}, {'title': 'SBP; Week 24; n=11, 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.0', 'spread': '12.28', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '13.82', 'groupId': 'OG001'}]}]}, {'title': 'SBP; Week 48; n=6, 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'spread': '19.50', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '12.57', 'groupId': 'OG001'}]}]}, {'title': 'DBP; Baseline; n=14, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '78.9', 'spread': '12.51', 'groupId': 'OG000'}, {'value': '75.1', 'spread': '8.46', 'groupId': 'OG001'}]}]}, {'title': 'DBP; Week 24; n=11, 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'spread': '9.49', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '10.35', 'groupId': 'OG001'}]}]}, {'title': 'DBP; Week 48; n=6, 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.2', 'spread': '13.92', 'groupId': 'OG000'}, {'value': '-3.2', 'spread': '8.78', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Weeks 24 and 48', 'description': 'Vital signs including SBP and DBP were measured at Baseline, Week 24 and Week 48. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.', 'unitOfMeasure': 'millimeters of mercury', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in category titles).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Heart Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG 50 mg BID', 'description': 'Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.'}, {'id': 'OG001', 'title': 'Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase', 'description': 'Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.'}], 'classes': [{'title': 'Baseline; n=14, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72.5', 'spread': '9.70', 'groupId': 'OG000'}, {'value': '75.9', 'spread': '14.56', 'groupId': 'OG001'}]}]}, {'title': 'Week 24; n=11, 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.4', 'spread': '8.42', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '11.20', 'groupId': 'OG001'}]}]}, {'title': 'Week 48; 6, 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.2', 'spread': '11.03', 'groupId': 'OG000'}, {'value': '-2.5', 'spread': '17.76', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Weeks 24 and 48', 'description': 'Vital signs including heart rate was measured at Baseline, Week 24 and Week 48. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.', 'unitOfMeasure': 'beats per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in category titles).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Albumin Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG 50 mg BID', 'description': 'Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.'}, {'id': 'OG001', 'title': 'Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase', 'description': 'Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.'}], 'classes': [{'title': 'Albumin; Baseline; n=14, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '43.1', 'spread': '4.13', 'groupId': 'OG000'}, {'value': '43.4', 'spread': '3.88', 'groupId': 'OG001'}]}]}, {'title': 'Albumin; Week 24; n=11, 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '3.66', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '3.87', 'groupId': 'OG001'}]}]}, {'title': 'Albumin; Week 48; n=8, 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.3', 'spread': '2.55', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '3.69', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24 and 48', 'description': 'Blood samples were collected for the analysis of clinical chemistry parameters such as albumin. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.', 'unitOfMeasure': 'grams per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in category titles).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG 50 mg BID', 'description': 'Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.'}, {'id': 'OG001', 'title': 'Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase', 'description': 'Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.'}], 'classes': [{'title': 'ALP; Baseline; n=14, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '91.9', 'spread': '29.64', 'groupId': 'OG000'}, {'value': '114.9', 'spread': '106.74', 'groupId': 'OG001'}]}]}, {'title': 'ALP; Day 8; n=13, 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.9', 'spread': '14.01', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '9.41', 'groupId': 'OG001'}]}]}, {'title': 'ALP; Day 28; n=13, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-6.1', 'spread': '10.71', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '11.37', 'groupId': 'OG001'}]}]}, {'title': 'ALP; Week 8; n=11, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.6', 'spread': '15.6', 'groupId': 'OG000'}, {'value': '20.6', 'spread': '63.97', 'groupId': 'OG001'}]}]}, {'title': 'ALP; Week 12; n=12, 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '10.19', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '26.15', 'groupId': 'OG001'}]}]}, {'title': 'ALP; Week 16; n=10, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.1', 'spread': '12.02', 'groupId': 'OG000'}, {'value': '8.2', 'spread': '40.55', 'groupId': 'OG001'}]}]}, {'title': 'ALP; Week 24; n=11, 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.7', 'spread': '21.72', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '54.06', 'groupId': 'OG001'}]}]}, {'title': 'ALP; Week 32; n=11, 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.9', 'spread': '19.74', 'groupId': 'OG000'}, {'value': '20.5', 'spread': '35.89', 'groupId': 'OG001'}]}]}, {'title': 'ALP; Week 40; n=8, 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.3', 'spread': '20.26', 'groupId': 'OG000'}, {'value': '7.8', 'spread': '24.69', 'groupId': 'OG001'}]}]}, {'title': 'ALP; Week 48; n=8, 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28.0', 'spread': '67.54', 'groupId': 'OG000'}, {'value': '13.8', 'spread': '32.07', 'groupId': 'OG001'}]}]}, {'title': 'ALP; Week 60; n=5, 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.0', 'spread': '23.86', 'groupId': 'OG000'}, {'value': '12.8', 'spread': '35.98', 'groupId': 'OG001'}]}]}, {'title': 'ALP; Week 72; n=3, 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.0', 'spread': '19.29', 'groupId': 'OG000'}, {'value': '15.3', 'spread': '10.21', 'groupId': 'OG001'}]}]}, {'title': 'ALP; Week 84; n=0, 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.0', 'spread': 'NA', 'comment': 'Only one participant was analyzed for this treatment arm at this time point; thus, no standard deviation could be calculated for this single participant.', 'groupId': 'OG001'}]}]}, {'title': 'ALT; Baseline; n=14, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24.9', 'spread': '13.33', 'groupId': 'OG000'}, {'value': '37.4', 'spread': '22.70', 'groupId': 'OG001'}]}]}, {'title': 'ALT; Day 8; n=13, 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '7.02', 'groupId': 'OG000'}, {'value': '-3.8', 'spread': '11.91', 'groupId': 'OG001'}]}]}, {'title': 'ALT; Day 28; n=13, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '15.45', 'groupId': 'OG000'}, {'value': '-5.3', 'spread': '23.65', 'groupId': 'OG001'}]}]}, {'title': 'ALT; Week 8; n=11, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.2', 'spread': '20.30', 'groupId': 'OG000'}, {'value': '-9.2', 'spread': '17.93', 'groupId': 'OG001'}]}]}, {'title': 'ALT; Week 12; n=12, 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.4', 'spread': '4.94', 'groupId': 'OG000'}, {'value': '-8.7', 'spread': '23.36', 'groupId': 'OG001'}]}]}, {'title': 'ALT; Week 16; n=10, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.2', 'spread': '3.97', 'groupId': 'OG000'}, {'value': '-10.1', 'spread': '23.02', 'groupId': 'OG001'}]}]}, {'title': 'ALT; Week 24; n=11, 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.1', 'spread': '18.66', 'groupId': 'OG000'}, {'value': '-14.5', 'spread': '23.16', 'groupId': 'OG001'}]}]}, {'title': 'ALT; Week 32; n=11, 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.9', 'spread': '14.01', 'groupId': 'OG000'}, {'value': '-10.6', 'spread': '25.77', 'groupId': 'OG001'}]}]}, {'title': 'ALT; Week 40; n=8, 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.6', 'spread': '8.75', 'groupId': 'OG000'}, {'value': '-7.7', 'spread': '25.86', 'groupId': 'OG001'}]}]}, {'title': 'ALT; Week 48; n=8, 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.9', 'spread': '20.02', 'groupId': 'OG000'}, {'value': '-9.2', 'spread': '23.50', 'groupId': 'OG001'}]}]}, {'title': 'ALT; Week 60; n=5, 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.8', 'spread': '7.19', 'groupId': 'OG000'}, {'value': '-8.3', 'spread': '24.28', 'groupId': 'OG001'}]}]}, {'title': 'ALT; Week 72; n=3, 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.7', 'spread': '17.67', 'groupId': 'OG000'}, {'value': '-29.3', 'spread': '33.06', 'groupId': 'OG001'}]}]}, {'title': 'ALT; Week 84; n=0, 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.0', 'spread': 'NA', 'comment': 'Only one participant was analyzed for this treatment arm at this time point; thus, no standard deviation could be calculated for this single participant.', 'groupId': 'OG001'}]}]}, {'title': 'AST; Baseline; n=14, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28.9', 'spread': '11.13', 'groupId': 'OG000'}, {'value': '34.9', 'spread': '14.35', 'groupId': 'OG001'}]}]}, {'title': 'AST; Day 8; n=13, 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '11.50', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': '9.17', 'groupId': 'OG001'}]}]}, {'title': 'AST; Day 28; n=13, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.0', 'spread': '10.13', 'groupId': 'OG000'}, {'value': '-2.3', 'spread': '17.08', 'groupId': 'OG001'}]}]}, {'title': 'AST; Week 8; n=11, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.9', 'spread': '7.57', 'groupId': 'OG000'}, {'value': '-6.3', 'spread': '9.64', 'groupId': 'OG001'}]}]}, {'title': 'AST; Week 12; n=12, 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.8', 'spread': '4.07', 'groupId': 'OG000'}, {'value': '-5.1', 'spread': '11.78', 'groupId': 'OG001'}]}]}, {'title': 'AST; Week 16; n=10, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.0', 'spread': '2.94', 'groupId': 'OG000'}, {'value': '-6.6', 'spread': '12.27', 'groupId': 'OG001'}]}]}, {'title': 'AST; Week 24; n=11, 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.7', 'spread': '14.05', 'groupId': 'OG000'}, {'value': '-10.1', 'spread': '11.87', 'groupId': 'OG001'}]}]}, {'title': 'AST; Week 32; n=11, 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.7', 'spread': '6.83', 'groupId': 'OG000'}, {'value': '-7.4', 'spread': '13.14', 'groupId': 'OG001'}]}]}, {'title': 'AST; Week 40; n=8, 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.9', 'spread': '4.09', 'groupId': 'OG000'}, {'value': '-4.1', 'spread': '12.46', 'groupId': 'OG001'}]}]}, {'title': 'AST; Week 48; n=8, 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.0', 'spread': '27.77', 'groupId': 'OG000'}, {'value': '-5.4', 'spread': '10.47', 'groupId': 'OG001'}]}]}, {'title': 'AST; Week 60; n=5, 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.2', 'spread': '1.64', 'groupId': 'OG000'}, {'value': '-5.9', 'spread': '9.24', 'groupId': 'OG001'}]}]}, {'title': 'AST; Week 72; n=3, 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.3', 'spread': '8.50', 'groupId': 'OG000'}, {'value': '-13.8', 'spread': '12.31', 'groupId': 'OG001'}]}]}, {'title': 'AST; Week 84; n=0, 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-8.0', 'spread': 'NA', 'comment': 'Only one participant was analyzed for this treatment arm at this time point; thus, no standard deviation could be calculated for this single participant.', 'groupId': 'OG001'}]}]}, {'title': 'Creatine Kinase; Baseline; n=14, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '162.4', 'spread': '129.21', 'groupId': 'OG000'}, {'value': '130.3', 'spread': '76.46', 'groupId': 'OG001'}]}]}, {'title': 'Creatine Kinase; Day 8; n=13, 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.1', 'spread': '122.28', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '53.29', 'groupId': 'OG001'}]}]}, {'title': 'Creatine Kinase; Day 28; n=13, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-35.6', 'spread': '96.22', 'groupId': 'OG000'}, {'value': '37.0', 'spread': '123.10', 'groupId': 'OG001'}]}]}, {'title': 'Creatine Kinase; Week 8; n=11, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-16.4', 'spread': '106.99', 'groupId': 'OG000'}, {'value': '-7.3', 'spread': '68.19', 'groupId': 'OG001'}]}]}, {'title': 'Creatine Kinase; Week 12; n=12, 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-18.8', 'spread': '105.64', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '84.85', 'groupId': 'OG001'}]}]}, {'title': 'Creatine Kinase; Week 16; n=10, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '34.2', 'spread': '81.44', 'groupId': 'OG000'}, {'value': '80.5', 'spread': '305.19', 'groupId': 'OG001'}]}]}, {'title': 'Creatine Kinase; Week 24; n=11, 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-24.4', 'spread': '82.07', 'groupId': 'OG000'}, {'value': '-6.0', 'spread': '67.29', 'groupId': 'OG001'}]}]}, {'title': 'Creatine Kinase; Week 32; n=11, 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.3', 'spread': '54.41', 'groupId': 'OG000'}, {'value': '23.4', 'spread': '96.88', 'groupId': 'OG001'}]}]}, {'title': 'Creatine Kinase; Week 40; n=8, 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-50.0', 'spread': '93.45', 'groupId': 'OG000'}, {'value': '66.3', 'spread': '168.54', 'groupId': 'OG001'}]}]}, {'title': 'Creatine Kinase; Week 48; n=8, 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.8', 'spread': '71.57', 'groupId': 'OG000'}, {'value': '16.1', 'spread': '68.96', 'groupId': 'OG001'}]}]}, {'title': 'Creatine Kinase; Week 60; n=5, 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-12.2', 'spread': '23.30', 'groupId': 'OG000'}, {'value': '18.8', 'spread': '86.19', 'groupId': 'OG001'}]}]}, {'title': 'Creatine Kinase; Week 72; n=3, 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '35.0', 'spread': '68.61', 'groupId': 'OG000'}, {'value': '-29.0', 'spread': '76.27', 'groupId': 'OG001'}]}]}, {'title': 'Creatine Kinase; Week 84; n=0, 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-134.0', 'spread': 'NA', 'comment': 'Only one participant was analyzed for this treatment arm at this time point; thus, no standard deviation could be calculated for this single participant.', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 8, Day 28, Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84', 'description': 'Blood samples were collected for the analysis of clinical chemistry parameters such as ALP, ALT, AST and creatine kinase. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. NA indicates data was not available.', 'unitOfMeasure': 'International units per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in category titles).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total Bilirubin (T. Bil) and Creatinine Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG 50 mg BID', 'description': 'Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.'}, {'id': 'OG001', 'title': 'Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase', 'description': 'Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.'}], 'classes': [{'title': 'T. Bil.; Baseline; n=14, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.0', 'spread': '4.51', 'groupId': 'OG000'}, {'value': '7.5', 'spread': '3.14', 'groupId': 'OG001'}]}]}, {'title': 'T. Bil.; Day 8; n=13, 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.8', 'spread': '6.81', 'groupId': 'OG000'}, {'value': '-1.1', 'spread': '2.12', 'groupId': 'OG001'}]}]}, {'title': 'T. Bil.; Day 28; n=13, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '6.19', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '9.78', 'groupId': 'OG001'}]}]}, {'title': 'T. Bil.; Week 8; n=11, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '4.20', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '13.76', 'groupId': 'OG001'}]}]}, {'title': 'T. Bil.; Week 12; n=12, 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '4.76', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '2.14', 'groupId': 'OG001'}]}]}, {'title': 'T. Bil.; Week 16; n=10, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '3.89', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '10.89', 'groupId': 'OG001'}]}]}, {'title': 'T. Bil.; Week 24; n=11, 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '2.89', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '8.19', 'groupId': 'OG001'}]}]}, {'title': 'T. Bil.; Week 32; n=11, 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '3.20', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '10.16', 'groupId': 'OG001'}]}]}, {'title': 'T. Bil.; Week 40; n=8, 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '3.70', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '12.43', 'groupId': 'OG001'}]}]}, {'title': 'T. Bil.; Week 48; n=8, 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '4.13', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '12.18', 'groupId': 'OG001'}]}]}, {'title': 'T. Bil.; Week 60; n=5, 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.4', 'spread': '2.61', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '11.63', 'groupId': 'OG001'}]}]}, {'title': 'T. Bil.; Week 72; n=3, 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.3', 'spread': '4.16', 'groupId': 'OG000'}, {'value': '9.5', 'spread': '16.36', 'groupId': 'OG001'}]}]}, {'title': 'T. Bil.; Week 84; n=0, 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.0', 'spread': 'NA', 'comment': 'Only one participant was analyzed for this treatment arm at this time point; thus, no standard deviation could be calculated for this single participant.', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine; Baseline; n=14, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '86.94', 'spread': '18.971', 'groupId': 'OG000'}, {'value': '88.96', 'spread': '24.013', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine; Day 8; n=13, 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.96', 'spread': '24.505', 'groupId': 'OG000'}, {'value': '0.11', 'spread': '14.873', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine; Day 28; n=13, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.72', 'spread': '19.697', 'groupId': 'OG000'}, {'value': '13.58', 'spread': '21.030', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine; Week 8; n=11, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.15', 'spread': '8.570', 'groupId': 'OG000'}, {'value': '15.79', 'spread': '19.574', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine; Week 12; n=12, 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.86', 'spread': '9.153', 'groupId': 'OG000'}, {'value': '9.85', 'spread': '13.274', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine; Week 16; n=10, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.22', 'spread': '13.464', 'groupId': 'OG000'}, {'value': '7.68', 'spread': '13.031', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine; Week 24; n=11, 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.63', 'spread': '11.098', 'groupId': 'OG000'}, {'value': '13.31', 'spread': '17.347', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine; Week 32; n=11, 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.98', 'spread': '7.441', 'groupId': 'OG000'}, {'value': '15.96', 'spread': '11.902', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine; Week 40; n=8, 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.58', 'spread': '10.788', 'groupId': 'OG000'}, {'value': '12.94', 'spread': '13.870', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine; Week 48; n=8, 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.21', 'spread': '19.450', 'groupId': 'OG000'}, {'value': '12.85', 'spread': '9.128', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine; Week 60; n=5, 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.96', 'spread': '5.560', 'groupId': 'OG000'}, {'value': '11.72', 'spread': '15.820', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine; Week 72; n=3, 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.93', 'spread': '8.529', 'groupId': 'OG000'}, {'value': '13.25', 'spread': '16.957', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine; Week 84; n=0, 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.80', 'spread': 'NA', 'comment': 'Only one participant was analyzed for this treatment arm at this time point; thus, no standard deviation could be calculated for this single participant.', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 8, Day 28, Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84', 'description': 'Blood samples were collected for the analysis of clinical chemistry parameters such as T. Bil and creatinine. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. NA indicates data was not available.', 'unitOfMeasure': 'Micromoles per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in category titles)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG 50 mg BID', 'description': 'Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.'}, {'id': 'OG001', 'title': 'Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase', 'description': 'Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.'}], 'classes': [{'title': 'Cholesterol; Baseline; n=8, 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.819', 'spread': '0.9219', 'groupId': 'OG000'}, {'value': '4.725', 'spread': '1.7430', 'groupId': 'OG001'}]}]}, {'title': 'Cholesterol; Week 12; n=6, 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.433', 'spread': '0.4622', 'groupId': 'OG000'}, {'value': '0.538', 'spread': '0.9598', 'groupId': 'OG001'}]}]}, {'title': 'Cholesterol; Week 24; n=6, 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.308', 'spread': '0.3137', 'groupId': 'OG000'}, {'value': '0.585', 'spread': '1.0296', 'groupId': 'OG001'}]}]}, {'title': 'Cholesterol; Week 48; n=3, 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.567', 'spread': '0.2021', 'groupId': 'OG000'}, {'value': '0.421', 'spread': '1.2770', 'groupId': 'OG001'}]}]}, {'title': 'Cholesterol; Week 60; n=2, 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.375', 'spread': '0.9546', 'groupId': 'OG000'}, {'value': '-0.020', 'spread': '1.3326', 'groupId': 'OG001'}]}]}, {'title': 'Cholesterol; Week 72; n=0, 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.350', 'spread': 'NA', 'comment': 'Only one participant was analyzed for this treatment arm at this time point; thus, no standard deviation could be calculated for this single participant.', 'groupId': 'OG001'}]}]}, {'title': 'Chloride; Baseline; n=14, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '104.1', 'spread': '1.59', 'groupId': 'OG000'}, {'value': '105.4', 'spread': '3.32', 'groupId': 'OG001'}]}]}, {'title': 'Chloride; Day 8; n=13, 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '1.61', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '2.03', 'groupId': 'OG001'}]}]}, {'title': 'Chloride; Day 28; n=13, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '2.26', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '2.58', 'groupId': 'OG001'}]}]}, {'title': 'Chloride; Week 8; n=11, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '1.97', 'groupId': 'OG000'}, {'value': '-1.8', 'spread': '3.08', 'groupId': 'OG001'}]}]}, {'title': 'Chloride; Week 12; n=12, 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '1.71', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '2.73', 'groupId': 'OG001'}]}]}, {'title': 'Chloride; Week 16; n=10, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.4', 'spread': '1.90', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '2.73', 'groupId': 'OG001'}]}]}, {'title': 'Chloride; Week 24; n=11, 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.9', 'spread': '1.45', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '3.14', 'groupId': 'OG001'}]}]}, {'title': 'Chloride; Week 32; n=11, 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.1', 'spread': '2.21', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '2.57', 'groupId': 'OG001'}]}]}, {'title': 'Chloride; Week 40; n=8, 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '2.51', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '2.80', 'groupId': 'OG001'}]}]}, {'title': 'Chloride; Week 48; n=8, 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '3.74', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '3.38', 'groupId': 'OG001'}]}]}, {'title': 'Chloride; Week 60; n=5, 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.0', 'spread': '2.12', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '2.81', 'groupId': 'OG001'}]}]}, {'title': 'Chloride; Week 72; n=3, 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.0', 'spread': '2.65', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '2.94', 'groupId': 'OG001'}]}]}, {'title': 'Chloride; Week 84; n=0, 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.0', 'spread': 'NA', 'comment': 'Only one participant was analyzed for this treatment arm at this time point; thus, no standard deviation could be calculated for this single participant.', 'groupId': 'OG001'}]}]}, {'title': 'CO2/HCO3; Baseline; n=14, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.5', 'spread': '2.07', 'groupId': 'OG000'}, {'value': '20.8', 'spread': '4.12', 'groupId': 'OG001'}]}]}, {'title': 'CO2/HCO3; Day 8; n=13, 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '1.30', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '2.25', 'groupId': 'OG001'}]}]}, {'title': 'CO2/HCO3; Day 28; n=13, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '2.29', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '2.47', 'groupId': 'OG001'}]}]}, {'title': 'CO2/HCO3; Week 8; n=11, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.2', 'spread': '1.66', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '3.40', 'groupId': 'OG001'}]}]}, {'title': 'CO2/HCO3; Week 12; n=12, 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.7', 'spread': '1.92', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '2.73', 'groupId': 'OG001'}]}]}, {'title': 'CO2/HCO3; Week 16; n=10, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '2.39', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '3.42', 'groupId': 'OG001'}]}]}, {'title': 'CO2/HCO3; Week 24; n=11, 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.9', 'spread': '1.92', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '2.92', 'groupId': 'OG001'}]}]}, {'title': 'CO2/HCO3; Week 32; n=11, 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '2.21', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '2.69', 'groupId': 'OG001'}]}]}, {'title': 'CO2/HCO3; Week 40; n=8, 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.9', 'spread': '2.30', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '2.25', 'groupId': 'OG001'}]}]}, {'title': 'CO2/HCO3; Week 48; n=8, 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '2.13', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '3.01', 'groupId': 'OG001'}]}]}, {'title': 'CO2/HCO3; Week 60; n=5, 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.8', 'spread': '1.30', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '2.42', 'groupId': 'OG001'}]}]}, {'title': 'CO2/HCO3; Week 72; n=3, 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.0', 'spread': '3.61', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '1.89', 'groupId': 'OG001'}]}]}, {'title': 'CO2/HCO3; Week 84; n=0, 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.0', 'spread': 'NA', 'comment': 'Only one participant was analyzed for this treatment arm at this time point; thus, no standard deviation could be calculated for this single participant.', 'groupId': 'OG001'}]}]}, {'title': 'Glucose; Baseline; n=12, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.84', 'spread': '0.535', 'groupId': 'OG000'}, {'value': '5.56', 'spread': '1.994', 'groupId': 'OG001'}]}]}, {'title': 'Glucose; Week 12; n=11, 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.677', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '0.679', 'groupId': 'OG001'}]}]}, {'title': 'Glucose; Week 24; n=10, 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.17', 'spread': '0.957', 'groupId': 'OG000'}, {'value': '-0.08', 'spread': '1.024', 'groupId': 'OG001'}]}]}, {'title': 'Glucose; Week 48; n=7, 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.13', 'spread': '0.439', 'groupId': 'OG000'}, {'value': '0.40', 'spread': '1.143', 'groupId': 'OG001'}]}]}, {'title': 'Glucose; Week 60; n=3, 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.20', 'spread': '0.300', 'groupId': 'OG000'}, {'value': '-0.18', 'spread': '0.723', 'groupId': 'OG001'}]}]}, {'title': 'Glucose; Week 72; n=2, 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.45', 'spread': '0.071', 'groupId': 'OG000'}, {'value': '0.20', 'spread': '0.744', 'groupId': 'OG001'}]}]}, {'title': 'HDL Cholesterol; Baseline; n=8, 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.956', 'spread': '0.2718', 'groupId': 'OG000'}, {'value': '1.090', 'spread': '0.2846', 'groupId': 'OG001'}]}]}, {'title': 'HDL Cholesterol; Week 12; n=6, 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.117', 'spread': '0.0683', 'groupId': 'OG000'}, {'value': '0.156', 'spread': '0.2485', 'groupId': 'OG001'}]}]}, {'title': 'HDL Cholesterol; Week 24; n=6, 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.025', 'spread': '0.1864', 'groupId': 'OG000'}, {'value': '0.130', 'spread': '0.2573', 'groupId': 'OG001'}]}]}, {'title': 'HDL Cholesterol; Week 48; n=3, 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.117', 'spread': '0.1155', 'groupId': 'OG000'}, {'value': '0.136', 'spread': '0.3363', 'groupId': 'OG001'}]}]}, {'title': 'HDL Cholesterol; Week 60; n=2, 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.025', 'spread': '0.0354', 'groupId': 'OG000'}, {'value': '0.010', 'spread': '0.3896', 'groupId': 'OG001'}]}]}, {'title': 'HDL Cholesterol; Week 72; n=0, 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.350', 'spread': 'NA', 'comment': 'Only one participant was analyzed for this treatment arm at this time point; thus, no standard deviation could be calculated for this single participant.', 'groupId': 'OG001'}]}]}, {'title': 'Potassium; Baseline; n=14, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.16', 'spread': '0.420', 'groupId': 'OG000'}, {'value': '4.13', 'spread': '0.377', 'groupId': 'OG001'}]}]}, {'title': 'Potassium; Day 8; n=13, 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.09', 'spread': '0.198', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '0.301', 'groupId': 'OG001'}]}]}, {'title': 'Potassium; Day 28; n=13, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.19', 'spread': '0.439', 'groupId': 'OG000'}, {'value': '0.14', 'spread': '0.518', 'groupId': 'OG001'}]}]}, {'title': 'Potassium; Week 8; n=11, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.12', 'spread': '0.379', 'groupId': 'OG000'}, {'value': '0.19', 'spread': '0.421', 'groupId': 'OG001'}]}]}, {'title': 'Potassium; Week 12; n=12, 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.03', 'spread': '0.253', 'groupId': 'OG000'}, {'value': '0.06', 'spread': '0.373', 'groupId': 'OG001'}]}]}, {'title': 'Potassium; Week 16; n=10, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.06', 'spread': '0.360', 'groupId': 'OG000'}, {'value': '-0.08', 'spread': '0.556', 'groupId': 'OG001'}]}]}, {'title': 'Potassium; Week 24; n=11, 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.17', 'spread': '0.374', 'groupId': 'OG000'}, {'value': '0.27', 'spread': '0.641', 'groupId': 'OG001'}]}]}, {'title': 'Potassium; Week 32; n=11, 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.04', 'spread': '0.329', 'groupId': 'OG000'}, {'value': '0.27', 'spread': '0.327', 'groupId': 'OG001'}]}]}, {'title': 'Potassium; Week 40; n=8, 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.189', 'groupId': 'OG000'}, {'value': '0.12', 'spread': '0.259', 'groupId': 'OG001'}]}]}, {'title': 'Potassium; Week 48; n=8, 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.15', 'spread': '0.532', 'groupId': 'OG000'}, {'value': '0.28', 'spread': '0.508', 'groupId': 'OG001'}]}]}, {'title': 'Potassium; Week 60; n=5, 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.06', 'spread': '0.288', 'groupId': 'OG000'}, {'value': '0.03', 'spread': '0.614', 'groupId': 'OG001'}]}]}, {'title': 'Potassium; Week 72; n=3, 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.37', 'spread': '0.208', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '0.512', 'groupId': 'OG001'}]}]}, {'title': 'Potassium; Week 84; n=0, 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.20', 'spread': 'NA', 'comment': 'Only one participant was analyzed for this treatment arm at this time point; thus, no standard deviation could be calculated for this single participant.', 'groupId': 'OG001'}]}]}, {'title': 'LDL Cholesterol; Baseline; n=8, 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.218', 'spread': '0.9134', 'groupId': 'OG000'}, {'value': '2.591', 'spread': '1.3696', 'groupId': 'OG001'}]}]}, {'title': 'LDL Cholesterol; Week 12; n=6, 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.293', 'spread': '0.4197', 'groupId': 'OG000'}, {'value': '0.500', 'spread': '0.5145', 'groupId': 'OG001'}]}]}, {'title': 'LDL Cholesterol; Week 24; n=6, 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.032', 'spread': '0.5854', 'groupId': 'OG000'}, {'value': '0.596', 'spread': '0.7389', 'groupId': 'OG001'}]}]}, {'title': 'LDL Cholesterol; Week 48; n=3, 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.330', 'spread': '0.0458', 'groupId': 'OG000'}, {'value': '0.322', 'spread': '0.7725', 'groupId': 'OG001'}]}]}, {'title': 'LDL Cholesterol; Week 60; n=2, 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.125', 'spread': '0.5303', 'groupId': 'OG000'}, {'value': '-0.008', 'spread': '1.0682', 'groupId': 'OG001'}]}]}, {'title': 'LDL Cholesterol; Week 72; n=0, 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.110', 'spread': 'NA', 'comment': 'Only one participant was analyzed for this treatment arm at this time point; thus, no standard deviation could be calculated for this single participant.', 'groupId': 'OG001'}]}]}, {'title': 'Sodium; Baseline; n=14, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '138.8', 'spread': '2.26', 'groupId': 'OG000'}, {'value': '138.5', 'spread': '2.22', 'groupId': 'OG001'}]}]}, {'title': 'Sodium; Day 8; n=13, 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '1.64', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '2.02', 'groupId': 'OG001'}]}]}, {'title': 'Sodium; Day 28; n=13, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '3.11', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '2.60', 'groupId': 'OG001'}]}]}, {'title': 'Sodium; Week 8; n=11, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '2.14', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '2.03', 'groupId': 'OG001'}]}]}, {'title': 'Sodium; Week 12; n=12, 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'spread': '1.88', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '2.53', 'groupId': 'OG001'}]}]}, {'title': 'Sodium; Week 16; n=10, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.3', 'spread': '2.06', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '1.94', 'groupId': 'OG001'}]}]}, {'title': 'Sodium; Week 24; n=11, 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '1.51', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '2.33', 'groupId': 'OG001'}]}]}, {'title': 'Sodium; Week 32; n=11, 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.8', 'spread': '1.60', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '1.41', 'groupId': 'OG001'}]}]}, {'title': 'Sodium; Week 40; n=8, 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '2.14', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '1.57', 'groupId': 'OG001'}]}]}, {'title': 'Sodium; Week 48; n=8, 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.9', 'spread': '3.56', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '2.40', 'groupId': 'OG001'}]}]}, {'title': 'Sodium; Week 60; n=5, 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.4', 'spread': '1.95', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '2.46', 'groupId': 'OG001'}]}]}, {'title': 'Sodium; Week 72; n=3, 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.3', 'spread': '2.52', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '1.50', 'groupId': 'OG001'}]}]}, {'title': 'Sodium; Week 84; n=0, 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': 'NA', 'comment': 'Only one participant was analyzed for this treatment arm at this time point; thus, no standard deviation could be calculated for this single participant.', 'groupId': 'OG001'}]}]}, {'title': 'Phosphorus, inorganic; Baseline; n=14, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.018', 'spread': '0.1552', 'groupId': 'OG000'}, {'value': '1.128', 'spread': '0.1390', 'groupId': 'OG001'}]}]}, {'title': 'Phosphorus, inorganic; Day 8; n=13, 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.012', 'spread': '0.1261', 'groupId': 'OG000'}, {'value': '-0.123', 'spread': '0.1635', 'groupId': 'OG001'}]}]}, {'title': 'Phosphorus, inorganic; Day 28; n=13, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.065', 'spread': '0.2357', 'groupId': 'OG000'}, {'value': '-0.075', 'spread': '0.1713', 'groupId': 'OG001'}]}]}, {'title': 'Phosphorus, inorganic; Week 8; n=11, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.018', 'spread': '0.1722', 'groupId': 'OG000'}, {'value': '-0.075', 'spread': '0.2244', 'groupId': 'OG001'}]}]}, {'title': 'Phosphorus, inorganic; Week 12; n=12, 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.033', 'spread': '0.1542', 'groupId': 'OG000'}, {'value': '-0.054', 'spread': '0.1322', 'groupId': 'OG001'}]}]}, {'title': 'Phosphorus, inorganic; Week 16; n=10, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.080', 'spread': '0.2263', 'groupId': 'OG000'}, {'value': '-0.053', 'spread': '0.2617', 'groupId': 'OG001'}]}]}, {'title': 'Phosphorus, inorganic; Week 24; n=11, 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.050', 'spread': '0.1204', 'groupId': 'OG000'}, {'value': '-0.023', 'spread': '0.1954', 'groupId': 'OG001'}]}]}, {'title': 'Phosphorus, inorganic; Week 32; n=11, 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.036', 'spread': '0.1343', 'groupId': 'OG000'}, {'value': '-0.050', 'spread': '0.1787', 'groupId': 'OG001'}]}]}, {'title': 'Phosphorus, inorganic; Week 40; n=8, 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.000', 'spread': '0.1035', 'groupId': 'OG000'}, {'value': '-0.046', 'spread': '0.2340', 'groupId': 'OG001'}]}]}, {'title': 'Phosphorus, inorganic; Week 48; n=8, 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.025', 'spread': '0.1282', 'groupId': 'OG000'}, {'value': '-0.031', 'spread': '0.1331', 'groupId': 'OG001'}]}]}, {'title': 'Phosphorus, inorganic; Week 60; n=5, 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.020', 'spread': '0.1304', 'groupId': 'OG000'}, {'value': '-0.042', 'spread': '0.1311', 'groupId': 'OG001'}]}]}, {'title': 'Phosphorus, inorganic; Week 72; n=3, 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.017', 'spread': '0.1258', 'groupId': 'OG000'}, {'value': '0.013', 'spread': '0.1031', 'groupId': 'OG001'}]}]}, {'title': 'Phosphorus, inorganic; Week 84; n=0, 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.100', 'spread': 'NA', 'comment': 'Only one participant was analyzed for this treatment arm at this time point; thus, no standard deviation could be calculated for this single participant.', 'groupId': 'OG001'}]}]}, {'title': 'Triglycerides; Baseline; n=8, 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.410', 'spread': '0.5005', 'groupId': 'OG000'}, {'value': '2.336', 'spread': '1.1103', 'groupId': 'OG001'}]}]}, {'title': 'Triglycerides; Week 12; n=6, 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.047', 'spread': '0.6380', 'groupId': 'OG000'}, {'value': '-0.260', 'spread': '1.1159', 'groupId': 'OG001'}]}]}, {'title': 'Triglycerides; Week 24; n=6, 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.547', 'spread': '0.9273', 'groupId': 'OG000'}, {'value': '-0.458', 'spread': '1.2066', 'groupId': 'OG001'}]}]}, {'title': 'Triglycerides; Week 48; n=3, 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.260', 'spread': '0.3894', 'groupId': 'OG000'}, {'value': '-0.486', 'spread': '1.3993', 'groupId': 'OG001'}]}]}, {'title': 'Triglycerides; Week 60; n=2, 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.590', 'spread': '0.8344', 'groupId': 'OG000'}, {'value': '-0.580', 'spread': '1.0562', 'groupId': 'OG001'}]}]}, {'title': 'Triglycerides; Week 72; n=0, 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.240', 'spread': 'NA', 'comment': 'Only one participant was analyzed for this treatment arm at this time point; thus, no standard deviation could be calculated for this single participant.', 'groupId': 'OG001'}]}]}, {'title': 'Urea/BUN; Baseline; n=14, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.64', 'spread': '1.167', 'groupId': 'OG000'}, {'value': '5.72', 'spread': '2.324', 'groupId': 'OG001'}]}]}, {'title': 'Urea/BUN; Day 8; n=13, 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.04', 'spread': '1.233', 'groupId': 'OG000'}, {'value': '-0.43', 'spread': '1.252', 'groupId': 'OG001'}]}]}, {'title': 'Urea/BUN; Day 28; n=13, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.23', 'spread': '1.678', 'groupId': 'OG000'}, {'value': '-0.13', 'spread': '1.875', 'groupId': 'OG001'}]}]}, {'title': 'Urea/BUN; Week 8; n=11, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.09', 'spread': '1.200', 'groupId': 'OG000'}, {'value': '-0.59', 'spread': '1.985', 'groupId': 'OG001'}]}]}, {'title': 'Urea/BUN; Week 12; n=12, 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.25', 'spread': '1.270', 'groupId': 'OG000'}, {'value': '-0.50', 'spread': '1.676', 'groupId': 'OG001'}]}]}, {'title': 'Urea/BUN; Week 16; n=10, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.05', 'spread': '1.787', 'groupId': 'OG000'}, {'value': '-1.00', 'spread': '1.304', 'groupId': 'OG001'}]}]}, {'title': 'Urea/BUN; Week 24; n=11, 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.09', 'spread': '1.200', 'groupId': 'OG000'}, {'value': '-0.27', 'spread': '1.841', 'groupId': 'OG001'}]}]}, {'title': 'Urea/BUN; Week 32; n=11, 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.55', 'spread': '1.150', 'groupId': 'OG000'}, {'value': '0.57', 'spread': '1.708', 'groupId': 'OG001'}]}]}, {'title': 'Urea/BUN; Week 40; n=8, 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.19', 'spread': '1.387', 'groupId': 'OG000'}, {'value': '0.29', 'spread': '1.339', 'groupId': 'OG001'}]}]}, {'title': 'Urea/BUN; Week 48; n=8, 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.38', 'spread': '1.157', 'groupId': 'OG000'}, {'value': '0.88', 'spread': '1.927', 'groupId': 'OG001'}]}]}, {'title': 'Urea/BUN; Week 60; n=5, 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.30', 'spread': '0.908', 'groupId': 'OG000'}, {'value': '0.54', 'spread': '1.888', 'groupId': 'OG001'}]}]}, {'title': 'Urea/BUN; Week 72; n=3, 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.50', 'spread': '0.500', 'groupId': 'OG000'}, {'value': '0.50', 'spread': '0.408', 'groupId': 'OG001'}]}]}, {'title': 'Urea/BUN; Week 84; n=0, 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Only one participant was analyzed for this treatment arm at this time point; thus, no standard deviation could be calculated for this single participant.', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 8, Day 28, Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84', 'description': 'Blood samples were collected for the analysis of clinical chemistry parameters such as cholesterol, chloride, CO2/HCO3, glucose, high density lipoprotein (HDL) cholesterol, potassium, LDL cholesterol, sodium, phosphorus inorganic, triglycerides and urea/blood urea nitrogen (BUN). Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. NA indicates data was not available.', 'unitOfMeasure': 'Millimoles per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Lipid and glucose parameters were only summarized on fasting data. Only those participants available at the specified time points were analyzed (represented by n=X in category titles)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Creatinine Clearance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG 50 mg BID', 'description': 'Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.'}, {'id': 'OG001', 'title': 'Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase', 'description': 'Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.'}], 'classes': [{'title': 'Baseline; n=14, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '106.8', 'spread': '31.79', 'groupId': 'OG000'}, {'value': '104.8', 'spread': '36.96', 'groupId': 'OG001'}]}]}, {'title': 'Day 8; n=1, 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-13.0', 'spread': 'NA', 'comment': 'Only one participant was analyzed for this treatment arm at this time point; thus, no standard deviation could be calculated for this single participant.', 'groupId': 'OG000'}]}]}, {'title': 'Day 28; n=13, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-10.5', 'spread': '13.06', 'groupId': 'OG000'}, {'value': '-10.4', 'spread': '13.06', 'groupId': 'OG001'}]}]}, {'title': 'Week 8; n=0, 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-12.0', 'spread': 'NA', 'comment': 'Only one participant was analyzed for this treatment arm at this time point; thus, no standard deviation could be calculated for this single participant.', 'groupId': 'OG001'}]}]}, {'title': 'Week 16; n=10, 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-7.3', 'spread': '12.00', 'groupId': 'OG000'}, {'value': '-12.5', 'spread': '16.41', 'groupId': 'OG001'}]}]}, {'title': 'Week 24; n=11, 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.3', 'spread': '13.94', 'groupId': 'OG000'}, {'value': '-13.9', 'spread': '17.38', 'groupId': 'OG001'}]}]}, {'title': 'Week 32; n=9, 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.4', 'spread': '8.82', 'groupId': 'OG000'}, {'value': '-16.0', 'spread': '16.31', 'groupId': 'OG001'}]}]}, {'title': 'Week 48; n=6, 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-6.8', 'spread': '17.61', 'groupId': 'OG000'}, {'value': '-16.5', 'spread': '14.34', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 8, Day 28, Week 8, Week 16, Week 24, Week 32 and Week 48', 'description': 'Creatinine clearance was calculated using Cockcroft-Gault formula. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.', 'unitOfMeasure': 'Milliliters per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in category titles)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Lipase Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG 50 mg BID', 'description': 'Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.'}, {'id': 'OG001', 'title': 'Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase', 'description': 'Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.'}], 'classes': [{'title': 'Lipase; Baseline; n=14, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29.1', 'spread': '12.37', 'groupId': 'OG000'}, {'value': '34.0', 'spread': '18.54', 'groupId': 'OG001'}]}]}, {'title': 'Lipase; Day 8; n=14, 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.4', 'spread': '9.19', 'groupId': 'OG000'}, {'value': '12.5', 'spread': '32.97', 'groupId': 'OG001'}]}]}, {'title': 'Lipase; Day 28; n=13, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.3', 'spread': '9.18', 'groupId': 'OG000'}, {'value': '17.7', 'spread': '63.64', 'groupId': 'OG001'}]}]}, {'title': 'Lipase; Week 8; n=11, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.6', 'spread': '8.65', 'groupId': 'OG000'}, {'value': '13.6', 'spread': '42.89', 'groupId': 'OG001'}]}]}, {'title': 'Lipase; Week 12; n=11, 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.4', 'spread': '8.91', 'groupId': 'OG000'}, {'value': '3.0', 'spread': '19.24', 'groupId': 'OG001'}]}]}, {'title': 'Lipase; Week 16; n=10, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.6', 'spread': '13.94', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '12.90', 'groupId': 'OG001'}]}]}, {'title': 'Lipase; Week 24; n=11, 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.7', 'spread': '9.91', 'groupId': 'OG000'}, {'value': '10.5', 'spread': '29.18', 'groupId': 'OG001'}]}]}, {'title': 'Lipase; Week 32; n=11, 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.8', 'spread': '9.82', 'groupId': 'OG000'}, {'value': '20.6', 'spread': '49.70', 'groupId': 'OG001'}]}]}, {'title': 'Lipase; Week 40; n=8, 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '8.53', 'groupId': 'OG000'}, {'value': '5.6', 'spread': '19.78', 'groupId': 'OG001'}]}]}, {'title': 'Lipase; Week 48; n=8, 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.8', 'spread': '6.18', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '16.05', 'groupId': 'OG001'}]}]}, {'title': 'Lipase; Week 60; n=5, 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.0', 'spread': '8.40', 'groupId': 'OG000'}, {'value': '5.9', 'spread': '22.01', 'groupId': 'OG001'}]}]}, {'title': 'Lipase; Week 72; n=3, 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.0', 'spread': '14.11', 'groupId': 'OG000'}, {'value': '41.0', 'spread': '94.20', 'groupId': 'OG001'}]}]}, {'title': 'Lipase; Week 84; n=0, 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-9.0', 'spread': 'NA', 'comment': 'Only one participant was analyzed for this treatment arm at this time point; thus, no standard deviation could be calculated for this single participant.', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 8, Day 28, Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84', 'description': 'Blood samples were collected for the analysis of clinical chemistry parameters such as lipase level. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. NA indicates data was not available.', 'unitOfMeasure': 'Units per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in category titles).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG 50 mg BID', 'description': 'Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.'}, {'id': 'OG001', 'title': 'Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase', 'description': 'Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.'}], 'classes': [{'title': 'Basophils; Baseline; n=14, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.016', 'spread': '0.0122', 'groupId': 'OG000'}, {'value': '0.015', 'spread': '0.0126', 'groupId': 'OG001'}]}]}, {'title': 'Basophils; Day 8; n=14, 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.006', 'spread': '0.0134', 'groupId': 'OG000'}, {'value': '0.002', 'spread': '0.0094', 'groupId': 'OG001'}]}]}, {'title': 'Basophils; Day 28; n=13, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.005', 'spread': '0.0176', 'groupId': 'OG000'}, {'value': '0.004', 'spread': '0.0222', 'groupId': 'OG001'}]}]}, {'title': 'Basophils; Week 8; n=11, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.001', 'spread': '0.0122', 'groupId': 'OG000'}, {'value': '0.004', 'spread': '0.0120', 'groupId': 'OG001'}]}]}, {'title': 'Basophils; Week 12; n=12, 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.001', 'spread': '0.0144', 'groupId': 'OG000'}, {'value': '0.000', 'spread': '0.0124', 'groupId': 'OG001'}]}]}, {'title': 'Basophils; Week 16; n=12, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.002', 'spread': '0.0147', 'groupId': 'OG000'}, {'value': '0.005', 'spread': '0.0137', 'groupId': 'OG001'}]}]}, {'title': 'Basophils; Week 24; n=11, 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.001', 'spread': '0.0158', 'groupId': 'OG000'}, {'value': '0.007', 'spread': '0.0188', 'groupId': 'OG001'}]}]}, {'title': 'Basophils; Week 32; n=11, 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.002', 'spread': '0.0108', 'groupId': 'OG000'}, {'value': '0.005', 'spread': '0.0185', 'groupId': 'OG001'}]}]}, {'title': 'Basophils; Week 40; n=8, 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.000', 'spread': '0.0207', 'groupId': 'OG000'}, {'value': '0.003', 'spread': '0.0144', 'groupId': 'OG001'}]}]}, {'title': 'Basophils; Week 48; n=8, 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.006', 'spread': '0.0130', 'groupId': 'OG000'}, {'value': '0.008', 'spread': '0.0174', 'groupId': 'OG001'}]}]}, {'title': 'Basophils; Week 60; n=5, 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.002', 'spread': '0.0164', 'groupId': 'OG000'}, {'value': '0.004', 'spread': '0.0173', 'groupId': 'OG001'}]}]}, {'title': 'Basophils; Week 72; n=3, 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.003', 'spread': '0.0153', 'groupId': 'OG000'}, {'value': '0.008', 'spread': '0.0275', 'groupId': 'OG001'}]}]}, {'title': 'Basophils; Week 84; n=0, 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.010', 'spread': 'NA', 'comment': 'Only one participant was analyzed for this treatment arm at this time point; thus, no standard deviation could be calculated for this single participant.', 'groupId': 'OG001'}]}]}, {'title': 'Eosinophils; Baseline; n=14, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.087', 'spread': '0.0935', 'groupId': 'OG000'}, {'value': '0.158', 'spread': '0.1681', 'groupId': 'OG001'}]}]}, {'title': 'Eosinophils; Day 8; n=14, 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.016', 'spread': '0.0388', 'groupId': 'OG000'}, {'value': '0.005', 'spread': '0.1076', 'groupId': 'OG001'}]}]}, {'title': 'Eosinophils; Day 28; n=13, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.023', 'spread': '0.0253', 'groupId': 'OG000'}, {'value': '0.033', 'spread': '0.1939', 'groupId': 'OG001'}]}]}, {'title': 'Eosinophils; Week 8; n=11, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.041', 'spread': '0.0561', 'groupId': 'OG000'}, {'value': '0.090', 'spread': '0.1464', 'groupId': 'OG001'}]}]}, {'title': 'Eosinophils; Week 12; n=12, 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.023', 'spread': '0.0492', 'groupId': 'OG000'}, {'value': '0.240', 'spread': '0.4390', 'groupId': 'OG001'}]}]}, {'title': 'Eosinophils; Week 16; n=12, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.024', 'spread': '0.0887', 'groupId': 'OG000'}, {'value': '0.141', 'spread': '0.3009', 'groupId': 'OG001'}]}]}, {'title': 'Eosinophils; Week 24; n=11, 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.003', 'spread': '0.0987', 'groupId': 'OG000'}, {'value': '0.159', 'spread': '0.3737', 'groupId': 'OG001'}]}]}, {'title': 'Eosinophils; Week 32; n=11, 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.016', 'spread': '0.1108', 'groupId': 'OG000'}, {'value': '0.075', 'spread': '0.1921', 'groupId': 'OG001'}]}]}, {'title': 'Eosinophils; Week 40; n=8, 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.015', 'spread': '0.1285', 'groupId': 'OG000'}, {'value': '0.011', 'spread': '0.1054', 'groupId': 'OG001'}]}]}, {'title': 'Eosinophils; Week 48; n=8, 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.028', 'spread': '0.1241', 'groupId': 'OG000'}, {'value': '0.122', 'spread': '0.2186', 'groupId': 'OG001'}]}]}, {'title': 'Eosinophils; Week 60; n=5, 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.038', 'spread': '0.1392', 'groupId': 'OG000'}, {'value': '0.098', 'spread': '0.2143', 'groupId': 'OG001'}]}]}, {'title': 'Eosinophils; Week 72; n=3, 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.043', 'spread': '0.1185', 'groupId': 'OG000'}, {'value': '0.053', 'spread': '0.0660', 'groupId': 'OG001'}]}]}, {'title': 'Eosinophils; Week 84; n=0, 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.240', 'spread': 'NA', 'comment': 'Only one participant was analyzed for this treatment arm at this time point; thus, no standard deviation could be calculated for this single participant.', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytes; Baseline; n=14, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.656', 'spread': '0.9039', 'groupId': 'OG000'}, {'value': '1.418', 'spread': '0.7921', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytes; Day 8; n=14, 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.165', 'spread': '0.4910', 'groupId': 'OG000'}, {'value': '0.040', 'spread': '0.3262', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytes; Day 28; n=13, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.132', 'spread': '0.4841', 'groupId': 'OG000'}, {'value': '0.297', 'spread': '0.3042', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytes; Week 8; n=11, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.490', 'spread': '0.5591', 'groupId': 'OG000'}, {'value': '0.536', 'spread': '0.6238', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytes; Week 12; n=12, 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.417', 'spread': '0.9401', 'groupId': 'OG000'}, {'value': '0.525', 'spread': '0.4922', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytes; Week 16; n=12, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.554', 'spread': '0.6402', 'groupId': 'OG000'}, {'value': '0.594', 'spread': '0.7014', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytes; Week 24; n=11, 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.271', 'spread': '0.7466', 'groupId': 'OG000'}, {'value': '0.647', 'spread': '0.8692', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytes; Week 32; n=11, 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.173', 'spread': '0.7166', 'groupId': 'OG000'}, {'value': '0.818', 'spread': '0.6910', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytes; Week 40; n=8, 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.169', 'spread': '0.6600', 'groupId': 'OG000'}, {'value': '0.519', 'spread': '0.6709', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytes; Week 48; n=8, 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.474', 'spread': '0.4207', 'groupId': 'OG000'}, {'value': '0.563', 'spread': '0.5703', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytes; Week 60; n=5, 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.526', 'spread': '0.3578', 'groupId': 'OG000'}, {'value': '0.663', 'spread': '0.6135', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytes; Week 72; n=3, 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.673', 'spread': '0.5327', 'groupId': 'OG000'}, {'value': '0.623', 'spread': '0.4280', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytes; Week 84; n=0, 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.640', 'spread': 'NA', 'comment': 'Only one participant was analyzed for this treatment arm at this time point; thus, no standard deviation could be calculated for this single participant.', 'groupId': 'OG001'}]}]}, {'title': 'Monocytes; Baseline; n=14, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.367', 'spread': '0.2075', 'groupId': 'OG000'}, {'value': '0.306', 'spread': '0.1117', 'groupId': 'OG001'}]}]}, {'title': 'Monocytes; Day 8; n=14, 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.003', 'spread': '0.2379', 'groupId': 'OG000'}, {'value': '0.027', 'spread': '0.1460', 'groupId': 'OG001'}]}]}, {'title': 'Monocytes; Day 28; n=13, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.042', 'spread': '0.1999', 'groupId': 'OG000'}, {'value': '0.031', 'spread': '0.1196', 'groupId': 'OG001'}]}]}, {'title': 'Monocytes; Week 8; n=11, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.022', 'spread': '0.1256', 'groupId': 'OG000'}, {'value': '0.037', 'spread': '0.1111', 'groupId': 'OG001'}]}]}, {'title': 'Monocytes; Week 12; n=12, 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.053', 'spread': '0.1215', 'groupId': 'OG000'}, {'value': '0.065', 'spread': '0.1075', 'groupId': 'OG001'}]}]}, {'title': 'Monocytes; Week 16; n=12, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.027', 'spread': '0.1262', 'groupId': 'OG000'}, {'value': '0.089', 'spread': '0.1430', 'groupId': 'OG001'}]}]}, {'title': 'Monocytes; Week 24; n=11, 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.067', 'spread': '0.1152', 'groupId': 'OG000'}, {'value': '0.017', 'spread': '0.1716', 'groupId': 'OG001'}]}]}, {'title': 'Monocytes; Week 32; n=11, 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.059', 'spread': '0.1208', 'groupId': 'OG000'}, {'value': '0.017', 'spread': '0.1616', 'groupId': 'OG001'}]}]}, {'title': 'Monocytes; Week 40; n=8, 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.030', 'spread': '0.0685', 'groupId': 'OG000'}, {'value': '0.011', 'spread': '0.0983', 'groupId': 'OG001'}]}]}, {'title': 'Monocytes; Week 48; n=8, 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.050', 'spread': '0.1598', 'groupId': 'OG000'}, {'value': '0.018', 'spread': '0.0985', 'groupId': 'OG001'}]}]}, {'title': 'Monocytes; Week 60; n=5, 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.088', 'spread': '0.1359', 'groupId': 'OG000'}, {'value': '-0.003', 'spread': '0.1305', 'groupId': 'OG001'}]}]}, {'title': 'Monocytes; Week 72; n=3, 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.003', 'spread': '0.0987', 'groupId': 'OG000'}, {'value': '0.055', 'spread': '0.1196', 'groupId': 'OG001'}]}]}, {'title': 'Monocytes; Week 84; n=0, 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.230', 'spread': 'NA', 'comment': 'Only one participant was analyzed for this treatment arm at this time point; thus, no standard deviation could be calculated for this single participant.', 'groupId': 'OG001'}]}]}, {'title': 'Total neutrophils; Baseline; n=14, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.327', 'spread': '1.2068', 'groupId': 'OG000'}, {'value': '1.869', 'spread': '1.0565', 'groupId': 'OG001'}]}]}, {'title': 'Total neutrophils; Day 8; n=14, 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.090', 'spread': '0.9029', 'groupId': 'OG000'}, {'value': '0.072', 'spread': '0.6338', 'groupId': 'OG001'}]}]}, {'title': 'Total neutrophils; Day 28; n=13, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.196', 'spread': '0.7017', 'groupId': 'OG000'}, {'value': '0.659', 'spread': '0.9376', 'groupId': 'OG001'}]}]}, {'title': 'Total neutrophils; Week 8; n=11, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.480', 'spread': '0.7919', 'groupId': 'OG000'}, {'value': '0.344', 'spread': '0.7325', 'groupId': 'OG001'}]}]}, {'title': 'Total neutrophils; Week 12; n=12, 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.022', 'spread': '0.5946', 'groupId': 'OG000'}, {'value': '0.357', 'spread': '0.5410', 'groupId': 'OG001'}]}]}, {'title': 'Total neutrophils; Week 16; n=12, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.780', 'spread': '1.7187', 'groupId': 'OG000'}, {'value': '1.030', 'spread': '0.7759', 'groupId': 'OG001'}]}]}, {'title': 'Total neutrophils; Week 24; n=11, 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.128', 'spread': '0.7851', 'groupId': 'OG000'}, {'value': '0.746', 'spread': '1.3053', 'groupId': 'OG001'}]}]}, {'title': 'Total neutrophils; Week 32; n=11, 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.213', 'spread': '0.9525', 'groupId': 'OG000'}, {'value': '0.875', 'spread': '1.0945', 'groupId': 'OG001'}]}]}, {'title': 'Total neutrophils; Week 40; n=8, 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.224', 'spread': '1.0274', 'groupId': 'OG000'}, {'value': '0.390', 'spread': '0.4501', 'groupId': 'OG001'}]}]}, {'title': 'Total neutrophils; Week 48; n=8, 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.144', 'spread': '0.5807', 'groupId': 'OG000'}, {'value': '0.986', 'spread': '1.0983', 'groupId': 'OG001'}]}]}, {'title': 'Total neutrophils; Week 60; n=5, 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.162', 'spread': '0.7959', 'groupId': 'OG000'}, {'value': '1.507', 'spread': '1.7191', 'groupId': 'OG001'}]}]}, {'title': 'Total neutrophils; Week 72; n=3, 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.783', 'spread': '1.6101', 'groupId': 'OG000'}, {'value': '2.363', 'spread': '2.0072', 'groupId': 'OG001'}]}]}, {'title': 'Total neutrophils; Week 84; n=0, 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.060', 'spread': 'NA', 'comment': 'Only one participant was analyzed for this treatment arm at this time point; thus, no standard deviation could be calculated for this single participant.', 'groupId': 'OG001'}]}]}, {'title': 'Platelet; Baseline; n=14, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '173.0', 'spread': '65.30', 'groupId': 'OG000'}, {'value': '176.9', 'spread': '56.97', 'groupId': 'OG001'}]}]}, {'title': 'Platelet; Day 8; n=14, 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.6', 'spread': '29.23', 'groupId': 'OG000'}, {'value': '16.5', 'spread': '29.08', 'groupId': 'OG001'}]}]}, {'title': 'Platelet; Day 28; n=13, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.9', 'spread': '29.87', 'groupId': 'OG000'}, {'value': '30.8', 'spread': '43.76', 'groupId': 'OG001'}]}]}, {'title': 'Platelet; Week 8; n=11, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '57.8', 'spread': '70.86', 'groupId': 'OG000'}, {'value': '29.1', 'spread': '57.51', 'groupId': 'OG001'}]}]}, {'title': 'Platelet; Week 12; n=12, 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36.5', 'spread': '33.68', 'groupId': 'OG000'}, {'value': '39.2', 'spread': '56.51', 'groupId': 'OG001'}]}]}, {'title': 'Platelet; Week 16; n=12, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '35.7', 'spread': '39.58', 'groupId': 'OG000'}, {'value': '52.6', 'spread': '56.43', 'groupId': 'OG001'}]}]}, {'title': 'Platelet; Week 24; n=11, 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.5', 'spread': '31.41', 'groupId': 'OG000'}, {'value': '58.7', 'spread': '64.10', 'groupId': 'OG001'}]}]}, {'title': 'Platelet; Week 32; n=11, 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.1', 'spread': '33.87', 'groupId': 'OG000'}, {'value': '55.6', 'spread': '74.60', 'groupId': 'OG001'}]}]}, {'title': 'Platelet; Week 40; n=8, 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.6', 'spread': '38.38', 'groupId': 'OG000'}, {'value': '44.9', 'spread': '48.17', 'groupId': 'OG001'}]}]}, {'title': 'Platelet; Week 48; n=8, 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24.6', 'spread': '36.49', 'groupId': 'OG000'}, {'value': '53.5', 'spread': '63.73', 'groupId': 'OG001'}]}]}, {'title': 'Platelet; Week 60; n=5, 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '43.0', 'spread': '18.36', 'groupId': 'OG000'}, {'value': '51.5', 'spread': '58.12', 'groupId': 'OG001'}]}]}, {'title': 'Platelet; Week 72; n=3, 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '34.3', 'spread': '40.15', 'groupId': 'OG000'}, {'value': '64.0', 'spread': '94.89', 'groupId': 'OG001'}]}]}, {'title': 'Platelet; Week 84; n=0, 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '88.0', 'spread': 'NA', 'comment': 'Only one participant was analyzed for this treatment arm at this time point; thus, no standard deviation could be calculated for this single participant.', 'groupId': 'OG001'}]}]}, {'title': 'WBC; Baseline; n=14, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.44', 'spread': '1.752', 'groupId': 'OG000'}, {'value': '3.78', 'spread': '1.522', 'groupId': 'OG001'}]}]}, {'title': 'WBC; Day 8; n=14, 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.29', 'spread': '1.082', 'groupId': 'OG000'}, {'value': '0.15', 'spread': '0.890', 'groupId': 'OG001'}]}]}, {'title': 'WBC; Day 28; n=13, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.33', 'spread': '0.946', 'groupId': 'OG000'}, {'value': '1.03', 'spread': '1.105', 'groupId': 'OG001'}]}]}, {'title': 'WBC; Week 8; n=11, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.00', 'spread': '1.015', 'groupId': 'OG000'}, {'value': '1.02', 'spread': '1.008', 'groupId': 'OG001'}]}]}, {'title': 'WBC; Week 12; n=12, 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.42', 'spread': '1.192', 'groupId': 'OG000'}, {'value': '1.19', 'spread': '1.005', 'groupId': 'OG001'}]}]}, {'title': 'WBC; Week 16; n=12, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.36', 'spread': '2.050', 'groupId': 'OG000'}, {'value': '1.86', 'spread': '1.398', 'groupId': 'OG001'}]}]}, {'title': 'WBC; Week 24; n=11, 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.09', 'spread': '1.276', 'groupId': 'OG000'}, {'value': '1.59', 'spread': '2.075', 'groupId': 'OG001'}]}]}, {'title': 'WBC; Week 32; n=11, 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.35', 'spread': '1.264', 'groupId': 'OG000'}, {'value': '1.78', 'spread': '1.600', 'groupId': 'OG001'}]}]}, {'title': 'WBC; Week 40; n=8, 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.36', 'spread': '1.162', 'groupId': 'OG000'}, {'value': '0.93', 'spread': '0.965', 'groupId': 'OG001'}]}]}, {'title': 'WBC; Week 48; n=8, 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.56', 'spread': '0.655', 'groupId': 'OG000'}, {'value': '1.70', 'spread': '1.480', 'groupId': 'OG001'}]}]}, {'title': 'WBC; Week 60; n=5, 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.58', 'spread': '0.973', 'groupId': 'OG000'}, {'value': '2.25', 'spread': '1.579', 'groupId': 'OG001'}]}]}, {'title': 'WBC; Week 72; n=3, 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.43', 'spread': '1.210', 'groupId': 'OG000'}, {'value': '3.10', 'spread': '2.349', 'groupId': 'OG001'}]}]}, {'title': 'WBC; Week 84; n=0, 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.70', 'spread': 'NA', 'comment': 'Only one participant was analyzed for this treatment arm at this time point; thus, no standard deviation could be calculated for this single participant.', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 8, Day 28, Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84', 'description': 'Blood samples were collected for the analysis of hematology parameters such as basophils, eosinophils. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. NA indicates data was not available.', 'unitOfMeasure': 'Giga cells per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in category titles)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hemoglobin Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG 50 mg BID', 'description': 'Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.'}, {'id': 'OG001', 'title': 'Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase', 'description': 'Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.'}], 'classes': [{'title': 'Baseline; n=14, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '132.9', 'spread': '16.16', 'groupId': 'OG000'}, {'value': '129.9', 'spread': '21.08', 'groupId': 'OG001'}]}]}, {'title': 'Day 8; n=14, 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'spread': '6.98', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '4.37', 'groupId': 'OG001'}]}]}, {'title': 'Day 28; n=13, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.5', 'spread': '8.76', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '9.62', 'groupId': 'OG001'}]}]}, {'title': 'Week 8; n=11, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.5', 'spread': '13.71', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '12.48', 'groupId': 'OG001'}]}]}, {'title': 'Week 12; n=12, 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'spread': '12.59', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '11.02', 'groupId': 'OG001'}]}]}, {'title': 'Week 16; n=12 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '15.47', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '10.14', 'groupId': 'OG001'}]}]}, {'title': 'Week 24; n=11, 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.6', 'spread': '10.60', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '8.82', 'groupId': 'OG001'}]}]}, {'title': 'Week 32; n=11, 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.4', 'spread': '10.66', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '9.49', 'groupId': 'OG001'}]}]}, {'title': 'Week 40; n=8, 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'spread': '12.14', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '11.32', 'groupId': 'OG001'}]}]}, {'title': 'Week 48; n=8, 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '9.80', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '13.48', 'groupId': 'OG001'}]}]}, {'title': 'Week 60; n=5, 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.8', 'spread': '13.99', 'groupId': 'OG000'}, {'value': '5.0', 'spread': '13.22', 'groupId': 'OG001'}]}]}, {'title': 'Week 72; n=3, 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.3', 'spread': '7.37', 'groupId': 'OG000'}, {'value': '7.0', 'spread': '8.72', 'groupId': 'OG001'}]}]}, {'title': 'Week 84; n=0, 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-6.0', 'spread': 'NA', 'comment': 'Only one participant was analyzed for this treatment arm at this time point; thus, no standard deviation could be calculated for this single participant.', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 8, Day 28, Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84', 'description': 'Blood samples were collected for the analysis of hematology parameters such as hemoglobin. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. NA indicates data was not available.', 'unitOfMeasure': 'Grams per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in category titles).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hematocrit Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG 50 mg BID', 'description': 'Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.'}, {'id': 'OG001', 'title': 'Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase', 'description': 'Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.'}], 'classes': [{'title': 'Baseline; n=14, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.4024', 'spread': '0.05259', 'groupId': 'OG000'}, {'value': '0.3974', 'spread': '0.06496', 'groupId': 'OG001'}]}]}, {'title': 'Day 8; n=14, 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.0015', 'spread': '0.02666', 'groupId': 'OG000'}, {'value': '-0.0049', 'spread': '0.01515', 'groupId': 'OG001'}]}]}, {'title': 'Day 28; n=13, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.0066', 'spread': '0.03105', 'groupId': 'OG000'}, {'value': '-0.0043', 'spread': '0.03313', 'groupId': 'OG001'}]}]}, {'title': 'Week 8; n=11, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.0105', 'spread': '0.04383', 'groupId': 'OG000'}, {'value': '0.0092', 'spread': '0.04092', 'groupId': 'OG001'}]}]}, {'title': 'Week 12; n=12, 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.0027', 'spread': '0.03702', 'groupId': 'OG000'}, {'value': '0.0054', 'spread': '0.03419', 'groupId': 'OG001'}]}]}, {'title': 'Week 16; n=12, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.0033', 'spread': '0.04275', 'groupId': 'OG000'}, {'value': '0.0021', 'spread': '0.03054', 'groupId': 'OG001'}]}]}, {'title': 'Week 24; n=11, 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.0025', 'spread': '0.03707', 'groupId': 'OG000'}, {'value': '0.0062', 'spread': '0.02787', 'groupId': 'OG001'}]}]}, {'title': 'Week 32; n=11, 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.0081', 'spread': '0.03310', 'groupId': 'OG000'}, {'value': '0.0062', 'spread': '0.03144', 'groupId': 'OG001'}]}]}, {'title': 'Week 40; n=8, 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.0005', 'spread': '0.03257', 'groupId': 'OG000'}, {'value': '0.0063', 'spread': '0.03601', 'groupId': 'OG001'}]}]}, {'title': 'Week 48; n=8, 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0065', 'spread': '0.02919', 'groupId': 'OG000'}, {'value': '0.0078', 'spread': '0.04331', 'groupId': 'OG001'}]}]}, {'title': 'Week 60; n=5, 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.0024', 'spread': '0.04000', 'groupId': 'OG000'}, {'value': '0.0200', 'spread': '0.04520', 'groupId': 'OG001'}]}]}, {'title': 'Week 72; n=3, 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.0170', 'spread': '0.03119', 'groupId': 'OG000'}, {'value': '0.0248', 'spread': '0.02943', 'groupId': 'OG001'}]}]}, {'title': 'Week 84; n=0, 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.0090', 'spread': 'NA', 'comment': 'Only one participant was analyzed for this treatment arm at this time point; thus, no standard deviation could be calculated for this single participant.', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 8, Day 28, Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84', 'description': 'Blood samples were collected for the analysis of hematology parameters such as hematocrit level. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. NA indicates data was not available.', 'unitOfMeasure': 'Proportion of red blood cells in blood', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in category titles)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Corpuscle Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG 50 mg BID', 'description': 'Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.'}, {'id': 'OG001', 'title': 'Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase', 'description': 'Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.'}], 'classes': [{'title': 'Baseline; n=14, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99.1', 'spread': '8.83', 'groupId': 'OG000'}, {'value': '97.8', 'spread': '9.28', 'groupId': 'OG001'}]}]}, {'title': 'Day 8; n=14, 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '2.35', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '1.71', 'groupId': 'OG001'}]}]}, {'title': 'Day 28; n=13, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.2', 'spread': '3.26', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '3.82', 'groupId': 'OG001'}]}]}, {'title': 'Week 8; n=11, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '3.77', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '6.02', 'groupId': 'OG001'}]}]}, {'title': 'Week 12; n=12, 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.1', 'spread': '7.73', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '7.39', 'groupId': 'OG001'}]}]}, {'title': 'Week 16; n=12, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '7.84', 'groupId': 'OG000'}, {'value': '-2.2', 'spread': '8.85', 'groupId': 'OG001'}]}]}, {'title': 'Week 24; n=11, 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '8.25', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': '10.36', 'groupId': 'OG001'}]}]}, {'title': 'Week 32; n=11, 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'spread': '8.54', 'groupId': 'OG000'}, {'value': '-2.4', 'spread': '10.87', 'groupId': 'OG001'}]}]}, {'title': 'Week 40; n=8, 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.5', 'spread': '8.75', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '11.41', 'groupId': 'OG001'}]}]}, {'title': 'Week 48; n=8, 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.0', 'spread': '7.76', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '11.73', 'groupId': 'OG001'}]}]}, {'title': 'Week 60; n=5, 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.4', 'spread': '7.89', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '11.82', 'groupId': 'OG001'}]}]}, {'title': 'Week 72; n=3, 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '10.12', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '14.10', 'groupId': 'OG001'}]}]}, {'title': 'Week 84; n=0, 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.0', 'spread': 'NA', 'comment': 'Only one participant was analyzed for this treatment arm at this time point; thus, no standard deviation could be calculated for this single participant.', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 8, Day 28, Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84', 'description': 'Blood samples were collected for the analysis of hematology parameters such as mean corpuscle volume. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. NA indicates data was not available.', 'unitOfMeasure': 'Femtoliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in category titles)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Red Blood Cell Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DTG 50 mg BID', 'description': 'Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.'}, {'id': 'OG001', 'title': 'Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase', 'description': 'Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.'}], 'classes': [{'title': 'Baseline; n=14, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.09', 'spread': '0.550', 'groupId': 'OG000'}, {'value': '4.09', 'spread': '0.731', 'groupId': 'OG001'}]}]}, {'title': 'Day 8; n=14, 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.254', 'groupId': 'OG000'}, {'value': '-0.04', 'spread': '0.140', 'groupId': 'OG001'}]}]}, {'title': 'Day 28; n=13, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.08', 'spread': '0.309', 'groupId': 'OG000'}, {'value': '-0.06', 'spread': '0.318', 'groupId': 'OG001'}]}]}, {'title': 'Week 8; n=11, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.14', 'spread': '0.434', 'groupId': 'OG000'}, {'value': '0.12', 'spread': '0.435', 'groupId': 'OG001'}]}]}, {'title': 'Week 12; n=12, 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.05', 'spread': '0.493', 'groupId': 'OG000'}, {'value': '0.15', 'spread': '0.477', 'groupId': 'OG001'}]}]}, {'title': 'Week 16; n=12, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.529', 'groupId': 'OG000'}, {'value': '0.13', 'spread': '0.478', 'groupId': 'OG001'}]}]}, {'title': 'Week 24; n=11, 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.02', 'spread': '0.464', 'groupId': 'OG000'}, {'value': '0.18', 'spread': '0.514', 'groupId': 'OG001'}]}]}, {'title': 'Week 32; n=11, 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.04', 'spread': '0.467', 'groupId': 'OG000'}, {'value': '0.18', 'spread': '0.504', 'groupId': 'OG001'}]}]}, {'title': 'Week 40; n=8, 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.08', 'spread': '0.392', 'groupId': 'OG000'}, {'value': '0.09', 'spread': '0.658', 'groupId': 'OG001'}]}]}, {'title': 'Week 48; n=8, 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.00', 'spread': '0.334', 'groupId': 'OG000'}, {'value': '0.15', 'spread': '0.625', 'groupId': 'OG001'}]}]}, {'title': 'Week 60; n=5, 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.06', 'spread': '0.428', 'groupId': 'OG000'}, {'value': '0.28', 'spread': '0.625', 'groupId': 'OG001'}]}]}, {'title': 'Week 72; n=3, 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.20', 'spread': '0.173', 'groupId': 'OG000'}, {'value': '0.25', 'spread': '0.759', 'groupId': 'OG001'}]}]}, {'title': 'Week 84; n=0, 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.60', 'spread': 'NA', 'comment': 'Only one participant was analyzed for this treatment arm at this time point; thus, no standard deviation could be calculated for this single participant.', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 8, Day 28, Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84', 'description': 'Blood samples were collected for the analysis of hematology parameters such as RBC. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. NA indicates data was not available.', 'unitOfMeasure': 'Trillion cells per liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in category titles)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'DTG 50 mg BID', 'description': 'Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.'}, {'id': 'FG001', 'title': 'Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase', 'description': 'Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.'}], 'periods': [{'title': 'Double-blind Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Open-label Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'One participant completing the DB Phase withdrew on Day 8 and did not enter the Open-label Phase.', 'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'Participants (par.) meeting eligibility criteria at screening entered a 7-day randomized, double-blind, placebo-controlled phase. At Day 8, all par. entered an open-label phase and continued to receive dolutegravir with an optimized background regimen. A total of 75 par. were screened; 45 par. were screen failures, and 30 par. were randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'DTG 50 mg BID', 'description': 'Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.'}, {'id': 'BG001', 'title': 'Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase', 'description': 'Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47.5', 'spread': '11.56', 'groupId': 'BG000'}, {'value': '48.6', 'spread': '8.85', 'groupId': 'BG001'}, {'value': '48.1', 'spread': '10.04', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'African American/African Heritage', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White - Arabic/North African Heritage', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White - White/Caucasian/European Heritage', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Missing: None of the Available Races Applied', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2013-12-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-14', 'studyFirstSubmitDate': '2012-03-29', 'resultsFirstSubmitDate': '2013-08-15', 'studyFirstSubmitQcDate': '2012-03-29', 'lastUpdatePostDateStruct': {'date': '2018-07-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-01-02', 'studyFirstPostDateStruct': {'date': '2012-04-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-02-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change From Baseline in Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) at Day 8', 'timeFrame': 'Baseline and Day 8', 'description': 'Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline (Day 1) and Day 8. Change from Baseline was calculated as the value at Day 8 minus the value at Baseline (Day 1). The analysis was performed using statistical modeling correcting for Baseline plasma HIV-1 RNA, Baseline Dolutegravir (DTG) fold change (FC), the overall susceptibility score (OSS) of the failing regimen, and the interaction between DTG FC and treatment. Means and differences were calculated using the average Baseline DTG FC of the entire Intent-to-Treat Exposed (ITT-E) Population. The last observation carried forward with discontinuation equals Baseline (LOCFDB) dataset was used for the analysis. For the LOCFDB dataset, missing values were carried forward from the previous, non-missing, available on-treatment assessment, except formissing values due to premature withdrawal or Day 8 missing values, which had the Baseline value imputed.'}], 'secondaryOutcomes': [{'measure': 'Absolute Values in Plasma HIV-1 RNA Over Time', 'timeFrame': 'Baseline; Day 8; Day 28; Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72, and 84', 'description': 'Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline (Day 1), Day 8, Day 28, Week 8, Week 12, Week 16, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, and Week 84. NA indicates data was not available.'}, {'measure': 'Mean Change From Baseline in Plasma HIV-1 RNA Over Time', 'timeFrame': 'Baseline; Day 8; Day 28; Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72, and 84', 'description': 'Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline (Day 1), Day 8, Day 28, Week 8, Week 12, Week 16, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, and Week 84. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. NA indicates data was not available.'}, {'measure': 'Number of Participants With Plasma HIV-1 RNA <50 c/mL Over Time', 'timeFrame': 'Baseline; Day 8; Day 28; Weeks 8, 12, 16, 24, 32, 40 and 48', 'description': "Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline (Day 1); Day 8; Day 28; Weeks 8, 12, 16, 24, 32, 40, and 48. Number of participants with plasma HIV-1 RNA level \\<50 c/mL was obtained using Food and Drug Administration's (FDA's) snapshot algorithm, where all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) were treated as non-responders. Also, participants who switched their concomitant antiretroviral therapy (ART) prior to the visit of interest as follows were also treated as non-responders: background ART substitutions not permitted per protocol; background ART substitutions permitted per protocol; however, the decision to switch is not documented as being before or at the first On-treatment visit after switching to optimized background regimen (OBR) (i.e. Day 28) where HIV-1 RNA is assessed."}, {'measure': 'Number of Participants With Plasma HIV-1 RNA <400 c/mL Over Time', 'timeFrame': 'Baseline; Day 8; Day 28; Weeks 8, 12, 16, 24, 32, 40 and 48', 'description': "Plasma samples were collected for quantitative HIV-1 RNA analysis at Baseline (Day 1); Day 8; Day 28; Weeks 8, 12, 16, 24, 32, 40 and 48. Number of participants with plasma HIV-1 RNA level \\<400 c/mL was obtained using FDA's snapshot algorithm, where all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) were treated as non-responders. Also, participants who switch their concomitant ART prior to the visit of interest as follows were also treated as non-responders: background ART substitutions not permitted per protocol; background ART substitutions permitted per protocol; however the decision to switch is not documented as being before or at the first On-treatment visit after switching to OBR (i.e. Day 28) where HIV-1 RNA is assessed."}, {'measure': 'Absolute Values in Cluster of Differentiation 4+ (CD4+) Cell Counts Over Time', 'timeFrame': 'Baseline; Day 8; Day 28; Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72, and 84', 'description': 'Blood samples were collected for lymphocyte subset assessment by flow cytometry at Baseline; Day 8; Day 28; Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72, and 84.'}, {'measure': 'Median Change From Baseline in CD4+ Cell Counts Over Time', 'timeFrame': 'Baseline; Day 8; Day 28; Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72, and 84', 'description': 'Blood samples were collected for lymphocyte subset assessment by flow cytometry at Baseline; Day 8; Day 28; Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72, and 84. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.'}, {'measure': 'Absolute Values in Cluster of Differentiation 8+ (CD8+) Cell Counts Over Time', 'timeFrame': 'Baseline; Day 28; Weeks 12, 24, and 48', 'description': 'Blood samples were collected for lymphocyte subset assessment by flow cytometry at Baseline; Day 28; and Weeks 12, 24, and 48.'}, {'measure': 'Median Change From Baseline in CD8+ Cell Counts Over Time', 'timeFrame': 'Baseline; Day 28; Weeks 12, 24, and 48', 'description': 'Blood samples were collected for lymphocyte subset assessment by flow cytometry at Baseline; Day 28; and Weeks 12, 24, and 48. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.'}, {'measure': 'Number of Participants With the Indicated Type of HIV-1 Disease Progression (Acquired Immunodeficiency Syndrome [AIDS] or Death [DT])', 'timeFrame': 'From the day of the first dose of study drug until early withdrawal or the Week 48 analysis cut-off date (median of 55 study weeks)', 'description': 'The number of participants with HIV-1 disease progression (AIDS or death) was assessed per the Centers for Disease Control and Prevention (CDC) 1993 revised classification system for HIV infection and expanded surveillance case definition for AIDS among adolescents and adults. The CDC classifies HIV infection as Category A (participants with asymptomatic HIV infection, acute HIV infection with accompanying illness, or persistent generalized lymphadenopathy), Category B (participants with symptomatic non-AIDS condition, i.e., conditions that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or conditions are considered by physicians to have a clinical course or to require management that is complicated by HIV infection), and Category C (includes AIDS indicator conditions as defined by diagnostic or presumptive measures).'}, {'measure': 'Number of Participants With Any Adverse Event (Serious and Non-serious) of the Indicated Grade', 'timeFrame': 'From the first dose of study medication until early withdrawal or through the Week 48 analysis data cut-off date (median of 55 study weeks)', 'description': 'An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as 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. Medical or scientific judgment should be exercised in other situations. Adverse events were graded for severity according to the Division of AIDS (DAIDS) toxicity scales as: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), or Grade 4 (potentially life threatening).'}, {'measure': 'Number of Participants With the Maximum Post-Baseline-emergent Clinical Chemistry Toxicities of the Indicated Grade', 'timeFrame': 'From the first dose of study medication until early withdrawal or through the Week 48 analysis data cut-off date (median of 55 study weeks)', 'description': 'Participants with post-Baseline-emergent clinical chemistry toxicities were analyzed. Clinical chemistry toxicities were graded for severity according to the DAIDS toxicity scales as: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), or Grade 4 (potentially life threatening).'}, {'measure': 'Number of Participants With the Maximum Post-Baseline-emergent Hematology Toxicities of the Indicated Grade', 'timeFrame': 'From the first dose of study medication until early withdrawal or through the Week 48 analysis data cut-off date (median of 55 study weeks)', 'description': 'Participants with post-Baseline-emergent hematology toxicities were analyzed. Hematology toxicities were graded for severity according to the DAIDS toxicity scales as: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), or Grade 4 (potentially life threatening).'}, {'measure': 'AUC(0-tau) of DTG', 'timeFrame': 'Day 8, Day 28, and Week 24', 'description': 'The area under the time concentration curve over the dosing interval (AUC\\[0-tau\\]) of DTG was assessed by a population pharmacokinetic (PK) modeling approach using pooled DTG PK data from multiple studies. Blood samples for the determination of plasma DTG concentration were collected at the following time points: pre-dose and 1-3 hours post-dose on Day 8; pre-dose and within a post-dose window (1-3 hours or 4-12 hours) on Day 28 and Week 24. For Day 8 PK, only samples collected from participants randomized to the active DTG arm were analyzed.'}, {'measure': 'Cmax of DTG', 'timeFrame': 'Day 8, Day 28, and Week 24', 'description': 'The maximal concentration (Cmax) of DTG was assessed by a population PK modeling approach using pooled DTG PK data from multiple studies. Blood samples for the determination of plasma DTG concentration were collected at the following time points: pre-dose and 1-3 hours post-dose on Day 8; pre-dose and within a post-dose window (1-3 hours or 4-12 hours) on Day 28 and Week 24. For Day 8 PK, only samples collected from participants randomized to the active DTG arm were analyzed.'}, {'measure': 'Plasma DTG Pre-dose Concentration (C0) at Day 8, Day 28, and Week 24; and Average DTG C0 (C0 Avg) at Week 24', 'timeFrame': 'Day 8, Day 28, and Week 24', 'description': 'Blood samples for the determination of plasma DTG pre-dose concentration were collected pre-dose on Day 8, Day 28, and Week 24. For Day 8 PK, only samples collected from participants randomized to the active DTG arm were analyzed. C0 Avg was calculated at Week 24 as the mean of the concentration at Day 8, Day 28, and Week 24.'}, {'measure': 'Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Defined Virologic Failure (PDVF), as a Measure of Genotypic Resistance', 'timeFrame': 'From the first dose of study medication until early withdrawal or through the Week 48 analysis data cut-off date (median of 55 study weeks)', 'description': 'For participants meeting one of the criteria for PDVF, plasma samples collected at the time point of virologic failure were tested to evaluate any potential genotypic and/or phenotypic evolution of resistance. PDVF was defined as (A) Virologic Non-response: a decrease in plasma HIV-1 RNA of \\<1 log10 copies/mL by Day 28, with subsequent confirmation, unless plasma HIV-1 RNA is \\<400 copies/mL; confirmed plasma HIV-1 RNA levels \\>=400 copies/mL on or after Week 24 or (B) Virologic Rebound: confirmed rebound in plasma HIV-1 RNA levels to \\>=400 copies/mL after prior confirmed suppression to \\<400 copies/mL; confirmed plasma HIV-1 RNA levels \\>1 log10 copies/mL above the nadir value, where nadir is \\>=400 copies/mL.Treatment-emergent IN mutations are those detected at the time of PDVF but not at Baseline.'}, {'measure': 'Number of Participants With the Indicated Fold Increase in Fold Change (FC) in the 50% Inhibitory Concentration Relative to Wild-type Virus for DTG (i.e. PDVF FC/Baseline FC Ratio) at the Time of PDVF, as a Measure of Phenotypic Resistance', 'timeFrame': 'From the first dose of study medication until early withdrawal or through the Week 48 analysis data cut-off date (median of 55 study weeks)', 'description': 'For participants meeting one of the criteria for PDVF, plasma samples collected at the time point of virologic failure were tested to evaluate any potential genotypic and/or phenotypic evolution of resistance. The FC in IC50 (50% inhibitory concentration) for DTG relative to wild-type virus was determined for virus isolated at Baseline and at the time of PDVF. The number of participants with the indicated change (ratio) in the two values at the time of PDVF is presented. PDVF was defined as (A) Virologic Non-response: a decrease in plasma HIV-1 RNA of \\<1 log10 copies/mL by Day 28, with subsequent confirmation, unless plasma HIV-1 RNA is \\<400 copies/mL; confirmed plasma HIV-1 RNA levels \\>=400 copies/mL on or after Week 24 or (B) Virologic Rebound: confirmed rebound in plasma HIV-1 RNA levels to \\>=400 copies/mL after prior confirmed suppression to \\<400 copies/mL; confirmed plasma HIV-1 RNA levels \\>1 log10 copies/mL above the nadir value, where nadir is \\>=400 copies/mL.'}, {'measure': 'Number of Participants Who Discontinued Study Treatment Due to AEs', 'timeFrame': 'From the first dose of study medication until early withdrawal or through the Week 48 analysis data cut-off date (median of 55 study weeks)', 'description': 'The number of participants who permanently discontinued study treatment due to AEs is presented.'}, {'measure': 'Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings', 'timeFrame': 'Up to Week 24', 'description': 'Twelve lead ECG was performed using an automated ECG machine. The number of participants with abnormal-clinically significant ECG findings at any time on-treatment is reported.'}, {'measure': 'Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)', 'timeFrame': 'Baseline and Weeks 24 and 48', 'description': 'Vital signs including SBP and DBP were measured at Baseline, Week 24 and Week 48. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.'}, {'measure': 'Change From Baseline in Heart Rate', 'timeFrame': 'Baseline and Weeks 24 and 48', 'description': 'Vital signs including heart rate was measured at Baseline, Week 24 and Week 48. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.'}, {'measure': 'Change From Baseline in Albumin Level', 'timeFrame': 'Baseline, Week 24 and 48', 'description': 'Blood samples were collected for the analysis of clinical chemistry parameters such as albumin. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.'}, {'measure': 'Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Creatine Kinase', 'timeFrame': 'Baseline, Day 8, Day 28, Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84', 'description': 'Blood samples were collected for the analysis of clinical chemistry parameters such as ALP, ALT, AST and creatine kinase. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. NA indicates data was not available.'}, {'measure': 'Change From Baseline in Total Bilirubin (T. Bil) and Creatinine Levels', 'timeFrame': 'Baseline, Day 8, Day 28, Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84', 'description': 'Blood samples were collected for the analysis of clinical chemistry parameters such as T. Bil and creatinine. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. NA indicates data was not available.'}, {'measure': 'Change From Baseline in Cholesterol, Chloride, Carbon Dioxide (CO2)/Bicarbonate (HCO3), Glucose, High Density Lipoprotein Cholesterol, Potassium, Low Density Lipoprotein (LDL) Cholesterol, Sodium, Phosphorus, Triglycerides and Urea/Blood Urea Nitrogen', 'timeFrame': 'Baseline, Day 8, Day 28, Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84', 'description': 'Blood samples were collected for the analysis of clinical chemistry parameters such as cholesterol, chloride, CO2/HCO3, glucose, high density lipoprotein (HDL) cholesterol, potassium, LDL cholesterol, sodium, phosphorus inorganic, triglycerides and urea/blood urea nitrogen (BUN). Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. NA indicates data was not available.'}, {'measure': 'Change From Baseline in Creatinine Clearance', 'timeFrame': 'Baseline, Day 8, Day 28, Week 8, Week 16, Week 24, Week 32 and Week 48', 'description': 'Creatinine clearance was calculated using Cockcroft-Gault formula. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline.'}, {'measure': 'Change From Baseline in Lipase Levels', 'timeFrame': 'Baseline, Day 8, Day 28, Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84', 'description': 'Blood samples were collected for the analysis of clinical chemistry parameters such as lipase level. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. NA indicates data was not available.'}, {'measure': 'Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Count', 'timeFrame': 'Baseline, Day 8, Day 28, Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84', 'description': 'Blood samples were collected for the analysis of hematology parameters such as basophils, eosinophils. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. NA indicates data was not available.'}, {'measure': 'Change From Baseline in Hemoglobin Level', 'timeFrame': 'Baseline, Day 8, Day 28, Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84', 'description': 'Blood samples were collected for the analysis of hematology parameters such as hemoglobin. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. NA indicates data was not available.'}, {'measure': 'Change From Baseline in Hematocrit Level', 'timeFrame': 'Baseline, Day 8, Day 28, Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84', 'description': 'Blood samples were collected for the analysis of hematology parameters such as hematocrit level. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. NA indicates data was not available.'}, {'measure': 'Change From Baseline in Mean Corpuscle Volume', 'timeFrame': 'Baseline, Day 8, Day 28, Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84', 'description': 'Blood samples were collected for the analysis of hematology parameters such as mean corpuscle volume. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. NA indicates data was not available.'}, {'measure': 'Change From Baseline in Red Blood Cell Count', 'timeFrame': 'Baseline, Day 8, Day 28, Weeks 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84', 'description': 'Blood samples were collected for the analysis of hematology parameters such as RBC. Baseline was defined as the last pre-treatment value. Change from Baseline was calculated as the post-Baseline value minus the value at Baseline. NA indicates data was not available.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ART-experienced', 'GSK1349572', 'Integrase inhibitor resistance', 'Dolutegravir'], 'conditions': ['HIV Infections']}, 'referencesModule': {'references': [{'pmid': '25321146', 'type': 'DERIVED', 'citation': 'Akil B, Blick G, Hagins DP, Ramgopal MN, Richmond GJ, Samuel RM, Givens N, Vavro C, Song IH, Wynne B, Ait-Khaled M; VIKING-4 study team. Dolutegravir versus placebo in subjects harbouring HIV-1 with integrase inhibitor resistance associated substitutions: 48-week results from VIKING-4, a randomized study. Antivir Ther. 2015;20(3):343-8. doi: 10.3851/IMP2878. Epub 2014 Oct 16.'}]}, 'descriptionModule': {'briefSummary': 'Study ING116529 is a multicenter, randomized, study with an initial 7 day placebo- controlled, functional monotherapy phase to quantify the antiviral activity attributable to dolutegravir (DTG) in HIV-1 infected, ART-experienced adults who are experiencing virological failure on an Integrase inhibitor containing regimen (current RAL or ELV failures), with evidence of genotypic resistance to RAL or ELV at study entry. Thirty subjects will be randomized (1:1) to receive either DTG 50mg BID (Arm A) or Placebo (Arm B) with the current failing regimen for 7 days (RAL or ELV should be discontinued prior to dosing with DTG). At Day 8, subjects from both arms will enter an open label phase and receive open label DTG 50mg BID with an optimized background regimen containing at least one fully active drug.', 'detailedDescription': 'Study ING116529 is a multicenter, randomized, study with an initial 7 day placebo-controlled, functional monotherapy phase to assess the antiviral activity and safety of a dolutegravir (DTG, GSK1349572) containing regimen in HIV-1 infected, ART-experienced adults with virological failure on an integrase inhibitor (INI) containing regimen.\n\nSubjects must have evidence of genotypic resistance to raltegravir \\[RAL\\] or elvitegravir \\[ELV\\] at Screening and documented current or historical genotypic or phenotypic resistance to at least two other antiretroviral therapy drug classes.\n\nThe study is designed to provide an accurate measure of the intrinsic antiviral activity of DTG 50mg twice daily versus placebo both administered with the current failing regimen in a randomised double-blind phase to Day 8. This will be followed by an open label phase with all subjects receiving DTG 50mg twice daily with an optimized background regimen (containing at least one fully active drug) until subjects no longer derive clinical benefit or until DTG is locally available. Thirty subjects will be randomized (1:1) to receive either DTG 50mg BID (Arm A) or Placebo (Arm B) with the current failing regimen for 7 days (RAL or ELV should be discontinued prior to dosing at Day 1). At Day 8, subjects from both arms will enter an open label phase and receive open label DTG 50mg BID with an optimized background regimen containing at least one fully active drug The primary analysis will be conducted after the last subject enrolled has completed the randomised, double-blind phase at Day 8. Additional analyses may be performed prior to study closure when all ongoing subjects transition to locally available commercial DTG.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Screening plasma HIV-1 RNA ≥1000 copies/mL\n* ART-experienced, INI-experienced, DTG naïve\n* Current virological failure on raltegravir (RAL) or elvitegravir (ELV) regimen\n* The subject's HIV-1 shows genotypic resistance to RAL or ELV at Screening\n* Subject has been on stable ART for at least one month prior to Screening and through Day 1(with exceptions for ETV, EFV and NVP that can be interrupted within 14 days of Day 1, see Exclusion Criterion)\n* Documented resistance to at least one drug from each of two or more of any approved classes of ART other than integrase inhibitors\n* Be able to receive at least one fully active drug as part of the OBR from Day 8\n* Women capable of becoming pregnant must use appropriate contraception during the study (as defined by the protocol)\n* Willing and able to understand and provide signed and dated written informed consent prior to Screening.\n\nExclusion Criteria:\n\n* Women who are pregnant or breast feeding\n* An active AIDS-defining condition at Screening (except cutaneous Kaposi's sarcoma not requiring systemic therapy or CD4+ \\<200c/mm3)\n* Moderate to severe hepatic impairment as defined by Child-Pugh classification\n* Anticipated need for HCV therapy during the first 24 weeks of the study\n* Recent history (less than or equal to 3 months) of any upper or lower gastrointestinal bleed, with the exception of anal or rectal bleeding\n* Allergy or intolerance to the study drugs or their components or drugs of their class\n* Malignancy within the past 6 months\n* Treatment with an HIV-1 therapeutic vaccine within 90 days of Screening\n* Treatment with radiation therapy, cytotoxic chemotherapeutic agents or any immunomodulator within 28 days of Screening\n* Treatment with any agent, other than licensed ART, with documented in vitro/vivo activity against HIV-1 within 28 days of first dose of investigational product (with the exception of entecavir if required for Hep B treatment)\n* Treatment with etravirine, efavirenz, or nevirapine within 14 days of Day 1(etravirine may be used if coadministered with lopinavir/ritonavir or darunavir/ritonavir)\n* Treatment with tipranivir/ritonavir, fosamprenavir, or fosamprenavir/ritonavir within 28 days prior to Screening\n* Exposure to an experimental drug or vaccine within either 28 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, which ever is longer, prior to the first dose of IP.\n* Any acute or verified Grade 4 laboratory abnormality (with the exception of Grade 4 lipids) at Screening\n* ALT\\> 5 times the upper limit of normal (ULN) at Screening\n* ALT ≥ 3X ULN and bilirubin \\> 1.5 X ULN (with 35% direct bilirubin) at Screening"}, 'identificationModule': {'nctId': 'NCT01568892', 'acronym': 'VIKING-4', 'briefTitle': 'Study Assessing Dolutegravir in HIV-1 Infected Subjects With Virus Resistant to Raltegravir and/or Elivitegravir', 'organization': {'class': 'INDUSTRY', 'fullName': 'ViiV Healthcare'}, 'officialTitle': 'A Phase III Randomized, Double-blind Study to Demonstrate the Antiviral Activity of Dolutegravir (DTG) 50 mg Twice Daily Versus Placebo Both Co-Administered With a Failing Antiretroviral Regimen Over Seven Days, Followed by an Open Label Phase With All Subjects Receiving DTG 50 mg Twice Daily Co-administered With an Optimised Background Regimen (OBR) in HIV-1 Infected, Integrase Inhibitor Therapy-Experienced and Resistant, Adults', 'orgStudyIdInfo': {'id': '116529'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DTG 50 mg BID', 'description': 'Subjects will receive dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all subjects will continue to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.', 'interventionNames': ['Drug: Dolutegravir 50 mg twice daily']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase', 'description': 'Subjects will receive matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all subjects will continue to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.', 'interventionNames': ['Drug: Dolutegravir 50 mg twice daily', 'Drug: Dolutegravir placebo twice daily']}], 'interventions': [{'name': 'Dolutegravir 50 mg twice daily', 'type': 'DRUG', 'otherNames': ['GSK1349572'], 'description': 'Active dolutegravir plus failing background regimen (Day 1 to Day 7). Open label dolutegravir plus optimized background regimen (from Day 8)', 'armGroupLabels': ['DTG 50 mg BID', 'Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase']}, {'name': 'Dolutegravir placebo twice daily', 'type': 'DRUG', 'otherNames': ['GSK1349572 Placebo'], 'description': 'Dolutegravir placebo plus failing background regimen (Day 1 to Day 7)', 'armGroupLabels': ['Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72207', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '93301', 'city': 'Bakersfield', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.37329, 'lon': -119.01871}}, {'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '90069', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92103-8208', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '06850', 'city': 'Norwalk', 'state': 'Connecticut', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.1176, 'lon': -73.4079}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '20009', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33316', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '34982', 'city': 'Ft. Pierce', 'state': 'Florida', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 27.44671, 'lon': -80.32561}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '30912', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '31401', 'city': 'Savannah', 'state': 'Georgia', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 32.08354, 'lon': -81.09983}}, {'zip': '60153', 'city': 'Maywood', 'state': 'Illinois', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.8792, 'lon': -87.84312}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '08844', 'city': 'Hillsborough', 'state': 'New Jersey', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 40.4776, 'lon': -74.62682}}, {'zip': '14215', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '10011', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '10595', 'city': 'Valhalla', 'state': 'New York', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.07482, 'lon': -73.77513}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '19140', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '22003', 'city': 'Annandale', 'state': 'Virginia', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 38.83039, 'lon': -77.19637}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'ViiV Healthcare'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ViiV Healthcare', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Shionogi', 'class': 'INDUSTRY'}, {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}