Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-27 @ 11:28 PM
Study NCT ID:
NCT00071760
Status:
COMPLETED
Last Update Posted:
2023-10-10
First Post:
2003-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study Of An Investigational Regimen Including FDA Approved HIV Drugs In HIV-Infected Pediatric Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Panama']}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'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': 'D012897', 'term': 'Slow 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': 'C426859', 'term': 'fosamprenavir'}, {'id': 'D019438', 'term': 'Ritonavir'}], 'ancestors': [{'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'GSKClinicalSupportHD@gsk.com', 'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'ViiV Healthcare'}, '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': 'All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 684 weeks.', 'description': 'All participants received FPV or FPV/RTV at any dose were included in the safety population.', 'eventGroups': [{'id': 'EG000', 'title': 'Cohort 2, Arm A - 4 Weeks to <6 Months', 'description': 'Participants with HIV-1 in Cohort 2 were initially administered with single dose administration of FPV/RTV 45/7 mg/kg (SDV1). The FPV/RTV dosage regimen selected for chronic dosing ranged from 30/7 mg/kg BID to 60/10 mg/kg BID. Subsequently enrolled participants were administered with FPV/RTV 45/10 mg/kg BID.', 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 24, 'seriousNumAtRisk': 29, 'deathsNumAffected': 1, 'seriousNumAffected': 13}, {'id': 'EG001', 'title': 'Cohort 1, Arm A - 6 Months to <2 Years', 'description': 'Participants with Human immunodeficiency virus (HIV-1) in Cohort 1 were initially administered single dose of fosamprenavir (FPV) 30 milligrams per kilogram (mg/kg) at single dose visit 1 (SDV1) or single dose of FPV/RTV 30/6 mg/kg (SDV2). Participants who underwent SDV2 administration began individualized regimens ranging from FPV 30 to 45/RTV 6 to 7 mg/kg twice a day (BID). Subsequently enrolled participants were administered with FPV/RTV 45/7 mg/kg BID.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 28, 'seriousNumAtRisk': 30, 'deathsNumAffected': 2, 'seriousNumAffected': 12}], 'otherEvents': [{'term': 'Otorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Aphthous ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 19, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Abdominal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Acarodermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Fungal skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Helminthic infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Impetigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Otitis media acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Pulmonary tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Tinea capitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Tinea infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Thermal burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Blood cholesterol', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Blood cholesterol increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Blood triglycerides increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Cardiac murmur', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Failure to thrive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Dermatitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Dermatitis diaper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Seborrhoeic dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Herpes simplex', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Measles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Molluscum contagiosum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Mumps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Otitis externa', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Otitis media chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Varicella', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 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'sourceVocabulary': 'MedDRA v25'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Skin laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Ear pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Excessive cerumen production', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Developmental delay', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Conjunctivitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Chalazion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Conjunctival hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Eye allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Strabismus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Febrile convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Ichthyosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Phimosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Hepatomegaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Immunisation reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Anogenital warts', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Educational problem', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}], 'seriousEvents': [{'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Hydrocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Iridocyclitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Abdominal symptom', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Hypertransaminasaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Arthritis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Escherichia urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Mastoiditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Meningitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Meningitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Otitis media chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Pneumonia viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Tracheobronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Greenstick fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Herbal toxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Pneumonitis chemical', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Thermal burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Hypernatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Kwashiorkor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Malnutrition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Anogenital warts', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Febrile convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Plasma Amprenavir (APV) AUC (0-tau[τ])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FPV/RTV BID: 4 Weeks to <6 Months', 'description': 'Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day \\[BID\\]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.'}, {'id': 'OG001', 'title': 'FPV/RTV BID: 6 Months to <2 Years', 'description': 'Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day \\[BID\\]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.'}], 'classes': [{'title': '45/10 mg/kg BID; n=9, 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.6', 'groupId': 'OG000', 'lowerLimit': '15.2', 'upperLimit': '46.8'}, {'value': '64.51', 'comment': 'The 95% CI is not available because the number of participants analyzed is 1.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': '60/10 mg/kg BID; n=2, 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '54.2', 'comment': 'The 95% CI is not available because the number of participants analyzed is 2.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '26.22', 'comment': 'The 95% CI is not available because the number of participants analyzed is 2.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': '45/7 mg/kg BID; n=2, 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '35.08', 'comment': 'The 95% CI is not available because the number of participants analyzed is 2.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '27.5', 'groupId': 'OG001', 'lowerLimit': '14.5', 'upperLimit': '52.1'}]}]}, {'title': '60/7 mg/kg BID; n=0, 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '48.4', 'groupId': 'OG001', 'lowerLimit': '12.9', 'upperLimit': '181.5'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 48', 'description': 'Plasma samples were assayed for APV concentrations using a validated assay. The GlaxoSmithKline (GSK) Department of Clinical Pharmacology Modeling and Simulation conducted pharmacokinetic (PK) analysis of the plasma APV concentration-time data using a model-independent approach. As a measure of total drug exposure, the area under the plasma-concentration-versus-time curve over the dosing interval at steady-state (AUC\\[0-τ\\]), where "τ" is the length of the dosing interval, was calculated by the linear up/log down trapezoidal method. hours, hr.', 'unitOfMeasure': 'Hr per microgram/milliliter (hr*µg/mL)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) Population: all participants for whom serial plasma PK samples were analyzed. Only those participants contributing data were analyzed.'}, {'type': 'PRIMARY', 'title': 'Plasma APV Cmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FPV/RTV BID: 4 Weeks to <6 Months', 'description': 'Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day \\[BID\\]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.'}, {'id': 'OG001', 'title': 'FPV/RTV BID: 6 Months to <2 Years', 'description': 'Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day \\[BID\\]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.'}], 'classes': [{'title': '45/10 mg/kg BID; n=9, 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.25', 'groupId': 'OG000', 'lowerLimit': '3.82', 'upperLimit': '10.2'}, {'value': '21.82', 'comment': 'The 95% CI is not available because the number of participants analyzed is 1.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': '60/10 mg/kg BID; n=2, 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.44', 'comment': 'The 95% CI is not available because the number of participants analyzed is 2.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '7.47', 'comment': 'The 95% CI is not available because the number of participants analyzed is 2.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': '45/7 mg/kg BID; n=2, 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.20', 'comment': 'The 95% CI is not available because the number of participants analyzed is 2.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '5.84', 'groupId': 'OG001', 'lowerLimit': '3.35', 'upperLimit': '10.2'}]}]}, {'title': '60/7 mg/kg BID; n=0, 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.4', 'groupId': 'OG001', 'lowerLimit': '3.64', 'upperLimit': '30.0'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 48', 'description': 'The maximum concentration at steady state (Cmax) was measured.', 'unitOfMeasure': 'Micrograms per milliliter (µg/mL)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population. Only those participants contributing data were analyzed.'}, {'type': 'PRIMARY', 'title': 'Plasma APV Cτ', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FPV/RTV BID: 4 Weeks to <6 Months', 'description': 'Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day \\[BID\\]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.'}, {'id': 'OG001', 'title': 'FPV/RTV BID: 6 Months to <2 Years', 'description': 'Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day \\[BID\\]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.'}], 'classes': [{'title': '45/10 mg/kg BID; n=11, 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.86', 'groupId': 'OG000', 'lowerLimit': '0.50', 'upperLimit': '1.48'}, {'value': '1.92', 'groupId': 'OG001', 'lowerLimit': '1.42', 'upperLimit': '2.58'}]}]}, {'title': '60/10 mg/kg BID; n=3, 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.60', 'comment': 'Because of the small sample size, the lower limit of the confidence interval cannot be reliably calculated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': '127.50'}, {'value': '2.58', 'groupId': 'OG001', 'lowerLimit': '1.29', 'upperLimit': '5.17'}]}]}, {'title': '45/7 mg/kg BID; n=3, 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.44', 'groupId': 'OG000', 'lowerLimit': '0.18', 'upperLimit': '1.07'}, {'value': '2.17', 'groupId': 'OG001', 'lowerLimit': '1.69', 'upperLimit': '2.80'}]}]}, {'title': '60/7 mg/kg BID; n=0, 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.81', 'groupId': 'OG001', 'lowerLimit': '1.69', 'upperLimit': '4.67'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 48', 'description': 'The plasma concentration at the end of the dosing interval at steady state (Cτ) was measured.', 'unitOfMeasure': 'Micrograms per milliliter (µg/mL)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population. Only those participants contributing data were analyzed.'}, {'type': 'PRIMARY', 'title': 'Plasma APV CL/F Following Dosing Expressed in mL/Min/kg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FPV/RTV BID: 4 Weeks to <6 Months', 'description': 'Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day \\[BID\\]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.'}, {'id': 'OG001', 'title': 'FPV/RTV BID: 6 Months to <2 Years', 'description': 'Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day \\[BID\\]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.'}], 'classes': [{'title': '45/10 mg/kg BID; n=9, 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.9', 'groupId': 'OG000', 'lowerLimit': '12.9', 'upperLimit': '40.6'}, {'value': '10.42', 'comment': 'The 95% CI is not available because the number of participants analyzed is 1.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': '60/10 mg/kg BID; n=2, 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.3', 'comment': 'The 95% CI is not available because the number of participants analyzed is 2.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '31.92', 'comment': 'The 95% CI is not available because the number of participants analyzed is 2.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': '45/7 mg/kg BID; n=2, 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.50', 'comment': 'The 95% CI is not available because the number of participants analyzed is 2.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '22.8', 'groupId': 'OG001', 'lowerLimit': '12.0', 'upperLimit': '43.1'}]}]}, {'title': '60/7 mg/kg BID; n=0, 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.8', 'groupId': 'OG001', 'lowerLimit': '4.75', 'upperLimit': '66.7'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 48', 'description': 'Apparent clearance of drug from plasma following extravascular administration (CL/F) was calculated using the formulation: APV Dose in mg/kg units divided by AUC(0-τ). For FPV, doses were expressed in APV molar equivalents (50 mg of FPV = 43.2 mg of APV). Normalizing CL/F for bodyweight allows for comparison of CL/F across populations.', 'unitOfMeasure': 'Milliliters/minute/kilogram (mL/min/kg)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population. Only those participants contributing data were analyzed.'}, {'type': 'PRIMARY', 'title': 'Plasma APV CL/F Following Dosing Expressed in mL/Min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FPV/RTV BID: 4 Weeks to <6 Months', 'description': 'Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day \\[BID\\]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.'}, {'id': 'OG001', 'title': 'FPV/RTV BID: 6 Months to <2 Years', 'description': 'Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day \\[BID\\]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.'}], 'classes': [{'title': '45/10 mg/kg BID; n=9, 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '135', 'groupId': 'OG000', 'lowerLimit': '69.1', 'upperLimit': '262'}, {'value': '62.5', 'comment': 'The 95% CI is not available because the number of participants analyzed is 1.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': '60/10 mg/kg BID; n=2, 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '86.4', 'comment': 'The 95% CI is not available because the number of participants analyzed is 2.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '234.3', 'comment': 'The 95% CI is not available because the number of participants analyzed is 2.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': '45/7 mg/kg BID; n=2, 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '106.7', 'comment': 'The 95% CI is not available because the number of participants analyzed is 2.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '190', 'groupId': 'OG001', 'lowerLimit': '93.2', 'upperLimit': '386.2'}]}]}, {'title': '60/7 mg/kg BID; n=0, 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '172', 'groupId': 'OG001', 'lowerLimit': '46.3', 'upperLimit': '638'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 48', 'description': 'Apparent clearance of drug from plasma following extravascular administration (CL/F) was calculated as dose/AUC(0-τ). For FPV, doses were expressed in APV molar equivalents (50 mg of FPV = 43.2 mg of APV).', 'unitOfMeasure': 'mL/min', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population. Only those participants contributing data were analyzed.'}, {'type': 'PRIMARY', 'title': 'Plasma Unbound APV Cτ', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FPV/RTV BID: 4 Weeks to <6 Months', 'description': 'Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day \\[BID\\]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.'}, {'id': 'OG001', 'title': 'FPV/RTV BID: 6 Months to <2 Years', 'description': 'Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day \\[BID\\]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.'}], 'classes': [{'title': '45/10 mg/kg BID; n=7, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.091', 'spread': '0.083', 'groupId': 'OG000'}, {'value': '0.087', 'spread': '0.076', 'groupId': 'OG001'}]}]}, {'title': '60/10 mg/kg BID; n=1, 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.003', 'spread': 'NA', 'comment': 'The standard deviation is not available because the number of participants analyzed is 1.', 'groupId': 'OG000'}, {'value': '0.069', 'spread': '0.052', 'groupId': 'OG001'}]}]}, {'title': '45/7 mg/kg BID; n=1, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.027', 'spread': 'NA', 'comment': 'The standard deviation is not available because the number of participants analyzed is 1.', 'groupId': 'OG000'}, {'value': '0.150', 'spread': '0.086', 'groupId': 'OG001'}]}]}, {'title': '60/7 mg/kg BID; n=0, 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.290', 'spread': '0.310', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 48', 'description': 'Participants who are \\<2 years old may have reduced protein binding; therefore, plasma unbound APV concentrations were measured to determine dosing recommendations at acceptable dosing volumes. Unbound or "free" APV is the fraction of drug that is not bound to protein. Cτ is the plasma concentration at the end of the dosing interval at steady state.', 'unitOfMeasure': 'µg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population. Only those participants contributing data were analyzed.'}, {'type': 'PRIMARY', 'title': 'Plasma Unbound APV Percent Protein Binding (%Cτ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FPV/RTV BID: 4 Weeks to <6 Months', 'description': 'Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day \\[BID\\]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.'}, {'id': 'OG001', 'title': 'FPV/RTV BID: 6 Months to <2 Years', 'description': 'Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day \\[BID\\]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.'}], 'classes': [{'title': '45/10 mg/kg BID; n=7, 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.79', 'spread': '2.05', 'groupId': 'OG000'}, {'value': '6.56', 'spread': '2.27', 'groupId': 'OG001'}]}]}, {'title': '60/10 mg/kg BID; n=1, 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.32', 'spread': 'NA', 'comment': 'The standard deviation is not available because the number of participants analyzed is 1.', 'groupId': 'OG000'}, {'value': '5.81', 'spread': '1.68', 'groupId': 'OG001'}]}]}, {'title': '45/7 mg/kg BID; n=1, 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.55', 'spread': 'NA', 'comment': 'The standard deviation is not available because the number of participants analyzed is 1.', 'groupId': 'OG000'}, {'value': '8.23', 'spread': '8.67', 'groupId': 'OG001'}]}]}, {'title': '60/7 mg/kg BID; n=0, 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.20', 'spread': '5.39', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 48', 'description': 'Participants who are \\<2 years old may have reduced protein binding; therefore, plasma unbound APV concentrations were measured to determine dosing recommendations at acceptable dosing volumes. APV %Cτ unbound is the percentage of the total APV Cτ that is unbound.', 'unitOfMeasure': 'Percentage of total APV Cτ unbound', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population. Only those participants contributing data were analyzed.'}, {'type': 'PRIMARY', 'title': 'Absolute Values of Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2, Arm A - 4 Weeks to <6 Months', 'description': 'Participants with HIV-1 in Cohort 2 were initially administered with single dose administration of FPV/RTV 45/7 mg/kg (SDV1). The FPV/RTV dosage regimen selected for chronic dosing ranged from 30/7 mg/kg BID to 60/10 mg/kg BID. Subsequently enrolled participants were administered with FPV/RTV 45/10 mg/kg BID.'}, {'id': 'OG001', 'title': 'Cohort 1, Arm A - 6 Months to <2 Years', 'description': 'Participants with Human immunodeficiency virus (HIV-1) in Cohort 1 were initially administered single dose of fosamprenavir (FPV) 30 milligrams per kilogram (mg/kg) at single dose visit 1 (SDV1) or single dose of FPV/RTV 30/6 mg/kg (SDV2). Participants who underwent SDV2 administration began individualized regimens ranging from FPV 30 to 45/RTV 6 to 7 mg/kg twice a day (BID). Subsequently enrolled participants were administered with FPV/RTV 45/7 mg/kg BID.'}], 'classes': [{'title': 'ALT, Day 1; n=26;30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.0', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '94'}, {'value': '20.0', 'groupId': 'OG001', 'lowerLimit': '9', 'upperLimit': '884'}]}]}, {'title': 'ALT, Week 4; n=23;28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.0', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '25'}, {'value': '15.5', 'groupId': 'OG001', 'lowerLimit': '8', 'upperLimit': '164'}]}]}, {'title': 'ALT, Week 12; n=22;27', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.0', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '35'}, {'value': '15.0', 'groupId': 'OG001', 'lowerLimit': '8', 'upperLimit': '39'}]}]}, {'title': 'ALT, Week 24; n=22;26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.0', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': '37'}, {'value': '15.5', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '111'}]}]}, {'title': 'ALT, Week 36; n=20;25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.5', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '51'}, {'value': '16.0', 'groupId': 'OG001', 'lowerLimit': '8', 'upperLimit': '134'}]}]}, {'title': 'ALT, Week 48; n=18;24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.0', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': '42'}, {'value': '16.0', 'groupId': 'OG001', 'lowerLimit': '9', 'upperLimit': '36'}]}]}, {'title': 'AST, Day 1; n=26;30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '43.5', 'groupId': 'OG000', 'lowerLimit': '24', 'upperLimit': '165'}, {'value': '44.0', 'groupId': 'OG001', 'lowerLimit': '29', 'upperLimit': '852'}]}]}, {'title': 'AST, Week 4; n=23;28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '32.0', 'groupId': 'OG000', 'lowerLimit': '21', 'upperLimit': '49'}, {'value': '35.0', 'groupId': 'OG001', 'lowerLimit': '23', 'upperLimit': '150'}]}]}, {'title': 'AST, Week 12; n=22;27', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '35.0', 'groupId': 'OG000', 'lowerLimit': '21', 'upperLimit': '63'}, {'value': '40.0', 'groupId': 'OG001', 'lowerLimit': '23', 'upperLimit': '67'}]}]}, {'title': 'AST, Week 24; n=22;26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '34.0', 'groupId': 'OG000', 'lowerLimit': '25', 'upperLimit': '43'}, {'value': '36.5', 'groupId': 'OG001', 'lowerLimit': '17', 'upperLimit': '109'}]}]}, {'title': 'AST, Week 36; n=20;24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '35.0', 'groupId': 'OG000', 'lowerLimit': '21', 'upperLimit': '58'}, {'value': '34.0', 'groupId': 'OG001', 'lowerLimit': '22', 'upperLimit': '105'}]}]}, {'title': 'AST, Week 48; n=18;23', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '34.5', 'groupId': 'OG000', 'lowerLimit': '17', 'upperLimit': '58'}, {'value': '34.0', 'groupId': 'OG001', 'lowerLimit': '22', 'upperLimit': '57'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (Day 1) and Weeks 4, 12, 24, 36, and 48', 'description': 'Blood samples of the participants were collected for the evaluation of ALT and AST. Clinical chemistry analyses were carried out using the observed analysis strategy.', 'unitOfMeasure': 'International units per liter (IU/L)', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population: all participants with documented evidence of having received at least one dose of investigational treatment. Only those participants contributing data were analyzed.'}, {'type': 'PRIMARY', 'title': 'Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2, Arm A - 4 Weeks to <6 Months', 'description': 'Participants with HIV-1 in Cohort 2 were initially administered with single dose administration of FPV/RTV 45/7 mg/kg (SDV1). The FPV/RTV dosage regimen selected for chronic dosing ranged from 30/7 mg/kg BID to 60/10 mg/kg BID. Subsequently enrolled participants were administered with FPV/RTV 45/10 mg/kg BID.'}, {'id': 'OG001', 'title': 'Cohort 1, Arm A - 6 Months to <2 Years', 'description': 'Participants with Human immunodeficiency virus (HIV-1) in Cohort 1 were initially administered single dose of fosamprenavir (FPV) 30 milligrams per kilogram (mg/kg) at single dose visit 1 (SDV1) or single dose of FPV/RTV 30/6 mg/kg (SDV2). Participants who underwent SDV2 administration began individualized regimens ranging from FPV 30 to 45/RTV 6 to 7 mg/kg twice a day (BID). Subsequently enrolled participants were administered with FPV/RTV 45/7 mg/kg BID.'}], 'classes': [{'title': 'Cholesterol, Day 1; n=22;29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.235', 'groupId': 'OG000', 'lowerLimit': '1.900', 'upperLimit': '2.780'}, {'value': '2.910', 'groupId': 'OG001', 'lowerLimit': '2.640', 'upperLimit': '3.530'}]}]}, {'title': 'Cholesterol, Week 4; n=4;2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.085', 'groupId': 'OG000', 'lowerLimit': '2.430', 'upperLimit': '3.180'}, {'value': '3.885', 'groupId': 'OG001', 'lowerLimit': '3.220', 'upperLimit': '4.550'}]}]}, {'title': 'Cholesterol, Week 12; n=0;2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.950', 'groupId': 'OG001', 'lowerLimit': '3.300', 'upperLimit': '4.550'}]}]}, {'title': 'Cholesterol, Week 24; n=22;26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.175', 'groupId': 'OG000', 'lowerLimit': '3.300', 'upperLimit': '5.210'}, {'value': '4.000', 'groupId': 'OG001', 'lowerLimit': '3.490', 'upperLimit': '5.050'}]}]}, {'title': 'Cholesterol, Week 36; n=3;2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.030', 'groupId': 'OG000', 'lowerLimit': '1.600', 'upperLimit': '3.390'}, {'value': '3.150', 'groupId': 'OG001', 'lowerLimit': '2.900', 'upperLimit': '3.400'}]}]}, {'title': 'Cholesterol, Week 48; n=18;24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.890', 'groupId': 'OG000', 'lowerLimit': '3.270', 'upperLimit': '4.700'}, {'value': '4.750', 'groupId': 'OG001', 'lowerLimit': '3.850', 'upperLimit': '5.285'}]}]}, {'title': 'Glucose, Day 1; n=26;30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.80', 'groupId': 'OG000', 'lowerLimit': '4.50', 'upperLimit': '5.20'}, {'value': '4.70', 'groupId': 'OG001', 'lowerLimit': '4.40', 'upperLimit': '5.20'}]}]}, {'title': 'Glucose, Week 4; n=23;28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.60', 'groupId': 'OG000', 'lowerLimit': '4.30', 'upperLimit': '5.30'}, {'value': '4.80', 'groupId': 'OG001', 'lowerLimit': '4.20', 'upperLimit': '5.20'}]}]}, {'title': 'Glucose, Week 12; n=22;27', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.70', 'groupId': 'OG000', 'lowerLimit': '4.10', 'upperLimit': '5.50'}, {'value': '4.70', 'groupId': 'OG001', 'lowerLimit': '4.30', 'upperLimit': '5.30'}]}]}, {'title': 'Glucose, Week 24; n=22;26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.55', 'groupId': 'OG000', 'lowerLimit': '4.00', 'upperLimit': '4.90'}, {'value': '4.30', 'groupId': 'OG001', 'lowerLimit': '4.00', 'upperLimit': '5.00'}]}]}, {'title': 'Glucose, Week 36; n=20;25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.50', 'groupId': 'OG000', 'lowerLimit': '4.35', 'upperLimit': '5.10'}, {'value': '4.60', 'groupId': 'OG001', 'lowerLimit': '4.30', 'upperLimit': '4.80'}]}]}, {'title': 'Glucose, Week 48; n=18;24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.45', 'groupId': 'OG000', 'lowerLimit': '4.20', 'upperLimit': '4.90'}, {'value': '4.70', 'groupId': 'OG001', 'lowerLimit': '4.35', 'upperLimit': '5.15'}]}]}, {'title': 'HDL, Day 1; n=22;29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.655', 'groupId': 'OG000', 'lowerLimit': '0.410', 'upperLimit': '0.810'}, {'value': '0.680', 'groupId': 'OG001', 'lowerLimit': '0.500', 'upperLimit': '0.850'}]}]}, {'title': 'HDL, Week 4; n=4;2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.825', 'groupId': 'OG000', 'lowerLimit': '0.585', 'upperLimit': '0.970'}, {'value': '0.690', 'groupId': 'OG001', 'lowerLimit': '0.650', 'upperLimit': '0.730'}]}]}, {'title': 'HDL, Week 12; n=0;2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.775', 'groupId': 'OG001', 'lowerLimit': '0.650', 'upperLimit': '0.900'}]}]}, {'title': 'HDL, Week 24; n=22;26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.900', 'groupId': 'OG000', 'lowerLimit': '0.720', 'upperLimit': '1.000'}, {'value': '0.960', 'groupId': 'OG001', 'lowerLimit': '0.800', 'upperLimit': '1.100'}]}]}, {'title': 'HDL, Week 36; n=3;2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.640', 'groupId': 'OG000', 'lowerLimit': '0.400', 'upperLimit': '0.700'}, {'value': '0.805', 'groupId': 'OG001', 'lowerLimit': '0.610', 'upperLimit': '1.000'}]}]}, {'title': 'HDL, Week 48; n=18;24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.825', 'groupId': 'OG000', 'lowerLimit': '0.730', 'upperLimit': '1.000'}, {'value': '1.050', 'groupId': 'OG001', 'lowerLimit': '0.805', 'upperLimit': '1.200'}]}]}, {'title': 'LDL, Day 1; n=22;28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.90', 'groupId': 'OG000', 'lowerLimit': '0.65', 'upperLimit': '1.15'}, {'value': '1.50', 'groupId': 'OG001', 'lowerLimit': '1.11', 'upperLimit': '1.94'}]}]}, {'title': 'LDL, Week 4; n=4;2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.25', 'groupId': 'OG000', 'lowerLimit': '0.85', 'upperLimit': '1.48'}, {'value': '2.45', 'groupId': 'OG001', 'lowerLimit': '1.90', 'upperLimit': '3.00'}]}]}, {'title': 'LDL, Week 12; n=0;2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.33', 'groupId': 'OG001', 'lowerLimit': '2.00', 'upperLimit': '2.66'}]}]}, {'title': 'LDL, Week 24; n=22;26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.08', 'groupId': 'OG000', 'lowerLimit': '1.10', 'upperLimit': '3.10'}, {'value': '2.32', 'groupId': 'OG001', 'lowerLimit': '2.00', 'upperLimit': '3.10'}]}]}, {'title': 'LDL, Week 36; n=3;2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.90', 'groupId': 'OG000', 'lowerLimit': '0.30', 'upperLimit': '2.10'}, {'value': '2.08', 'groupId': 'OG001', 'lowerLimit': '1.75', 'upperLimit': '2.40'}]}]}, {'title': 'LDL, Week 48; n=18;24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.33', 'groupId': 'OG000', 'lowerLimit': '1.70', 'upperLimit': '2.85'}, {'value': '2.80', 'groupId': 'OG001', 'lowerLimit': '2.50', 'upperLimit': '3.37'}]}]}, {'title': 'TG, Day 1; n=22;29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.695', 'groupId': 'OG000', 'lowerLimit': '1.220', 'upperLimit': '2.280'}, {'value': '1.650', 'groupId': 'OG001', 'lowerLimit': '1.300', 'upperLimit': '2.100'}]}]}, {'title': 'TG, Week 4; n=4;2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.015', 'groupId': 'OG000', 'lowerLimit': '1.505', 'upperLimit': '2.280'}, {'value': '1.645', 'groupId': 'OG001', 'lowerLimit': '1.310', 'upperLimit': '1.980'}]}]}, {'title': 'TG, Week 12; n=0;2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.810', 'groupId': 'OG001', 'lowerLimit': '0.800', 'upperLimit': '2.820'}]}]}, {'title': 'TG, Week 24; n=22;26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.155', 'groupId': 'OG000', 'lowerLimit': '1.580', 'upperLimit': '2.710'}, {'value': '1.550', 'groupId': 'OG001', 'lowerLimit': '1.100', 'upperLimit': '2.120'}]}]}, {'title': 'TG, Week 36; n=3;2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.310', 'groupId': 'OG000', 'lowerLimit': '1.100', 'upperLimit': '2.000'}, {'value': '1.700', 'groupId': 'OG001', 'lowerLimit': '1.100', 'upperLimit': '2.300'}]}]}, {'title': 'TG, Week 48; n=18;24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.590', 'groupId': 'OG000', 'lowerLimit': '1.270', 'upperLimit': '2.010'}, {'value': '1.390', 'groupId': 'OG001', 'lowerLimit': '0.920', 'upperLimit': '1.950'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (Day 1) and Weeks 4, 12, 24, 36, and 48', 'description': 'Blood samples of all participants were generally collected under non-fasting conditions (given the age of participants) for the evaluation of cholesterol, serum glucose, HDL cholesterol, LDL cholesterol and triglyceride (TG). Clinical chemistry analyses were carried out using the observed analysis strategy.', 'unitOfMeasure': 'Millimoles per liter (mmol/L)', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants contributing data were analyzed.'}, {'type': 'PRIMARY', 'title': 'Absolute Values of Serum Lipase at Baseline (Day 1), Weeks 4, 12, 24, and 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2, Arm A - 4 Weeks to <6 Months', 'description': 'Participants with HIV-1 in Cohort 2 were initially administered with single dose administration of FPV/RTV 45/7 mg/kg (SDV1). The FPV/RTV dosage regimen selected for chronic dosing ranged from 30/7 mg/kg BID to 60/10 mg/kg BID. Subsequently enrolled participants were administered with FPV/RTV 45/10 mg/kg BID.'}, {'id': 'OG001', 'title': 'Cohort 1, Arm A - 6 Months to <2 Years', 'description': 'Participants with Human immunodeficiency virus (HIV-1) in Cohort 1 were initially administered single dose of fosamprenavir (FPV) 30 milligrams per kilogram (mg/kg) at single dose visit 1 (SDV1) or single dose of FPV/RTV 30/6 mg/kg (SDV2). Participants who underwent SDV2 administration began individualized regimens ranging from FPV 30 to 45/RTV 6 to 7 mg/kg twice a day (BID). Subsequently enrolled participants were administered with FPV/RTV 45/7 mg/kg BID.'}], 'classes': [{'title': 'Day 1; n=2;11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.5', 'groupId': 'OG000', 'lowerLimit': '20.0', 'upperLimit': '21.0'}, {'value': '22.0', 'groupId': 'OG001', 'lowerLimit': '17.0', 'upperLimit': '38.0'}]}]}, {'title': 'Week 4; n=0;1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.0', 'groupId': 'OG001', 'lowerLimit': '16.0', 'upperLimit': '16.0'}]}]}, {'title': 'Week 12; n=0;1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '68.0', 'groupId': 'OG001', 'lowerLimit': '68.0', 'upperLimit': '68.0'}]}]}, {'title': 'Week 24; n=0;8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.5', 'groupId': 'OG001', 'lowerLimit': '14.5', 'upperLimit': '28.0'}]}]}, {'title': 'Week 48; n=1;8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.0', 'groupId': 'OG000', 'lowerLimit': '16.0', 'upperLimit': '16.0'}, {'value': '16.0', 'groupId': 'OG001', 'lowerLimit': '14.5', 'upperLimit': '24.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (Day 1) and Weeks 4, 12, 24, and 48', 'description': 'Blood samples of all participants were collected for the evaluation of serum lipase. Clinical chemistry analyses were carried out using the observed analysis strategy. Change from Baseline in serum lipase was calculated as the value at the indicated time point minus the value at Baseline.', 'unitOfMeasure': 'Units per liter (U/L)', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants contributing data were analyzed.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With the Indicated Treatment-emergent (TE) Grade 3/4 Laboratory Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2, Arm A - 4 Weeks to <6 Months', 'description': 'Participants with HIV-1 in Cohort 2 were initially administered with single dose administration of FPV/RTV 45/7 mg/kg (SDV1). The FPV/RTV dosage regimen selected for chronic dosing ranged from 30/7 mg/kg BID to 60/10 mg/kg BID. Subsequently enrolled participants were administered with FPV/RTV 45/10 mg/kg BID.'}, {'id': 'OG001', 'title': 'Cohort 1, Arm A - 6 Months to <2 Years', 'description': 'Participants with Human immunodeficiency virus (HIV-1) in Cohort 1 were initially administered single dose of fosamprenavir (FPV) 30 milligrams per kilogram (mg/kg) at single dose visit 1 (SDV1) or single dose of FPV/RTV 30/6 mg/kg (SDV2). Participants who underwent SDV2 administration began individualized regimens ranging from FPV 30 to 45/RTV 6 to 7 mg/kg twice a day (BID). Subsequently enrolled participants were administered with FPV/RTV 45/7 mg/kg BID.'}], 'classes': [{'title': 'Clinical Chemistry Toxicities - Grade 3', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Clinical Chemistry Toxicities - Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Hematology Toxicities - Grade 3', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Hematology Toxicities - Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day 1) until Week 48', 'description': 'TE toxicities were presented for each laboratory parameter. A toxicity was considered TE if it was greater than the Baseline grade, and if it was observed on/after the date of the first dose of study drug (SD), and on/before the date of the last dose of SD. Per the Division of AIDS Table for Grading the Severity of Adult and Pediatric AEs, Grade 3=severe; Grade 4=potentially life-threatening.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants contributing data were analyzed.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With the Indicated Treatment-emergent (TE) Grade 3/4 Adverse Events (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2, Arm A - 4 Weeks to <6 Months', 'description': 'Participants with HIV-1 in Cohort 2 were initially administered with single dose administration of FPV/RTV 45/7 mg/kg (SDV1). The FPV/RTV dosage regimen selected for chronic dosing ranged from 30/7 mg/kg BID to 60/10 mg/kg BID. Subsequently enrolled participants were administered with FPV/RTV 45/10 mg/kg BID.'}, {'id': 'OG001', 'title': 'Cohort 1, Arm A - 6 Months to <2 Years', 'description': 'Participants with Human immunodeficiency virus (HIV-1) in Cohort 1 were initially administered single dose of fosamprenavir (FPV) 30 milligrams per kilogram (mg/kg) at single dose visit 1 (SDV1) or single dose of FPV/RTV 30/6 mg/kg (SDV2). Participants who underwent SDV2 administration began individualized regimens ranging from FPV 30 to 45/RTV 6 to 7 mg/kg twice a day (BID). Subsequently enrolled participants were administered with FPV/RTV 45/7 mg/kg BID.'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day 1) until Week 48', 'description': 'An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE is considered TE if it has an onset date on or after the date of the first dose of study drug, and on or before the date of the final dose of study drug. As per the Division of AIDS Table for Grading the Severity of Adult and Pediatric AEs, Grade 3=severe; Grade 4=potentially life-threatening.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. In addition to the 54 participants starting FPV/RTV BID treatment, the FPV/RTV BID treatment group includes 5 participants who only received investigational product at the single dose visits in APV20002.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Permanently Discontinued the Treatment Due to an AE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2, Arm A - 4 Weeks to <6 Months', 'description': 'Participants with HIV-1 in Cohort 2 were initially administered with single dose administration of FPV/RTV 45/7 mg/kg (SDV1). The FPV/RTV dosage regimen selected for chronic dosing ranged from 30/7 mg/kg BID to 60/10 mg/kg BID. Subsequently enrolled participants were administered with FPV/RTV 45/10 mg/kg BID.'}, {'id': 'OG001', 'title': 'Cohort 1, Arm A - 6 Months to <2 Years', 'description': 'Participants with Human immunodeficiency virus (HIV-1) in Cohort 1 were initially administered single dose of fosamprenavir (FPV) 30 milligrams per kilogram (mg/kg) at single dose visit 1 (SDV1) or single dose of FPV/RTV 30/6 mg/kg (SDV2). Participants who underwent SDV2 administration began individualized regimens ranging from FPV 30 to 45/RTV 6 to 7 mg/kg twice a day (BID). Subsequently enrolled participants were administered with FPV/RTV 45/7 mg/kg BID.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day 1) until Week 48', 'description': 'An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. In addition to the 54 participants starting FPV/RTV BID treatment, the FPV/RTV BID treatment group includes 5 participants who only received investigational product at the single dose visits in APV20002.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Treatment Emergent Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2, Arm A - 4 Weeks to <6 Months', 'description': 'Participants with HIV-1 in Cohort 2 were initially administered with single dose administration of FPV/RTV 45/7 mg/kg (SDV1). The FPV/RTV dosage regimen selected for chronic dosing ranged from 30/7 mg/kg BID to 60/10 mg/kg BID. Subsequently enrolled participants were administered with FPV/RTV 45/10 mg/kg BID.'}, {'id': 'OG001', 'title': 'Cohort 1, Arm A - 6 Months to <2 Years', 'description': 'Participants with Human immunodeficiency virus (HIV-1) in Cohort 1 were initially administered single dose of fosamprenavir (FPV) 30 milligrams per kilogram (mg/kg) at single dose visit 1 (SDV1) or single dose of FPV/RTV 30/6 mg/kg (SDV2). Participants who underwent SDV2 administration began individualized regimens ranging from FPV 30 to 45/RTV 6 to 7 mg/kg twice a day (BID). Subsequently enrolled participants were administered with FPV/RTV 45/7 mg/kg BID.'}], 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 and up to week 684', 'description': 'An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (that could include a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included participants receiving FPV or FPV/RTV at any dose.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Clinical Chemistry Toxicities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2, Arm A - 4 Weeks to <6 Months', 'description': 'Participants with HIV-1 in Cohort 2 were initially administered with single dose administration of FPV/RTV 45/7 mg/kg (SDV1). The FPV/RTV dosage regimen selected for chronic dosing ranged from 30/7 mg/kg BID to 60/10 mg/kg BID. Subsequently enrolled participants were administered with FPV/RTV 45/10 mg/kg BID.'}, {'id': 'OG001', 'title': 'Cohort 1, Arm A - 6 Months to <2 Years', 'description': 'Participants with Human immunodeficiency virus (HIV-1) in Cohort 1 were initially administered single dose of fosamprenavir (FPV) 30 milligrams per kilogram (mg/kg) at single dose visit 1 (SDV1) or single dose of FPV/RTV 30/6 mg/kg (SDV2). Participants who underwent SDV2 administration began individualized regimens ranging from FPV 30 to 45/RTV 6 to 7 mg/kg twice a day (BID). Subsequently enrolled participants were administered with FPV/RTV 45/7 mg/kg BID.'}], 'classes': [{'title': 'Grade 1', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Grade 2', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Grade 4', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 and up to Week 684', 'description': 'Blood samples were collected for the analysis of all clinical chemistry parameters. Laboratory toxicities were graded using the Division of AIDS (DAIDS) table for grading the severity of adult and pediatric adverse events, where grade 1=mild, grade 2=moderate, grade 3=severe and grade 4=potentially life-threatening. Results for participants with Grade 1 to 4 clinical chemistry toxicities is presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Hematology Toxicities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2, Arm A - 4 Weeks to <6 Months', 'description': 'Participants with HIV-1 in Cohort 2 were initially administered with single dose administration of FPV/RTV 45/7 mg/kg (SDV1). The FPV/RTV dosage regimen selected for chronic dosing ranged from 30/7 mg/kg BID to 60/10 mg/kg BID. Subsequently enrolled participants were administered with FPV/RTV 45/10 mg/kg BID.'}, {'id': 'OG001', 'title': 'Cohort 1, Arm A - 6 Months to <2 Years', 'description': 'Participants with Human immunodeficiency virus (HIV-1) in Cohort 1 were initially administered single dose of fosamprenavir (FPV) 30 milligrams per kilogram (mg/kg) at single dose visit 1 (SDV1) or single dose of FPV/RTV 30/6 mg/kg (SDV2). Participants who underwent SDV2 administration began individualized regimens ranging from FPV 30 to 45/RTV 6 to 7 mg/kg twice a day (BID). Subsequently enrolled participants were administered with FPV/RTV 45/7 mg/kg BID.'}], 'classes': [{'title': 'Grade 1', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Grade 2', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 and up to Week 684', 'description': 'Blood samples were collected for the analysis of all hematology parameters. Laboratory toxicities were graded using the DAIDS Table for grading the severity of adult and pediatric adverse events, where grade 1=mild, grade 2=moderate, grade 3=severe and grade 4=potentially life-threatening. Results for participants with Grade 1 to 4 hematology toxicities is presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Treatment Limiting Toxicities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2, Arm A - 4 Weeks to <6 Months', 'description': 'Participants with HIV-1 in Cohort 2 were initially administered with single dose administration of FPV/RTV 45/7 mg/kg (SDV1). The FPV/RTV dosage regimen selected for chronic dosing ranged from 30/7 mg/kg BID to 60/10 mg/kg BID. Subsequently enrolled participants were administered with FPV/RTV 45/10 mg/kg BID.'}, {'id': 'OG001', 'title': 'Cohort 1, Arm A - 6 Months to <2 Years', 'description': 'Participants with Human immunodeficiency virus (HIV-1) in Cohort 1 were initially administered single dose of fosamprenavir (FPV) 30 milligrams per kilogram (mg/kg) at single dose visit 1 (SDV1) or single dose of FPV/RTV 30/6 mg/kg (SDV2). Participants who underwent SDV2 administration began individualized regimens ranging from FPV 30 to 45/RTV 6 to 7 mg/kg twice a day (BID). Subsequently enrolled participants were administered with FPV/RTV 45/7 mg/kg BID.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 and up to Week 684', 'description': 'Treatment limiting toxicities are defined as those that are related to investigational medicinal products and deemed to be unacceptable, leading to restriction of further dose escalation.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants Who Permanently Discontinued the Treatment Due to Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2, Arm A - 4 Weeks to <6 Months', 'description': 'Participants with HIV-1 in Cohort 2 were initially administered with single dose administration of FPV/RTV 45/7 mg/kg (SDV1). The FPV/RTV dosage regimen selected for chronic dosing ranged from 30/7 mg/kg BID to 60/10 mg/kg BID. Subsequently enrolled participants were administered with FPV/RTV 45/10 mg/kg BID.'}, {'id': 'OG001', 'title': 'Cohort 1, Arm A - 6 Months to <2 Years', 'description': 'Participants with Human immunodeficiency virus (HIV-1) in Cohort 1 were initially administered single dose of fosamprenavir (FPV) 30 milligrams per kilogram (mg/kg) at single dose visit 1 (SDV1) or single dose of FPV/RTV 30/6 mg/kg (SDV2). Participants who underwent SDV2 administration began individualized regimens ranging from FPV 30 to 45/RTV 6 to 7 mg/kg twice a day (BID). Subsequently enrolled participants were administered with FPV/RTV 45/7 mg/kg BID.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 and up to Week 684', 'description': 'An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (that could include a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat exposed'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2, Arm A - 4 Weeks to <6 Months', 'description': 'Participants with HIV-1 in Cohort 2 were initially administered with single dose administration of FPV/RTV 45/7 mg/kg (SDV1). The FPV/RTV dosage regimen selected for chronic dosing ranged from 30/7 mg/kg BID to 60/10 mg/kg BID. Subsequently enrolled participants were administered with FPV/RTV 45/10 mg/kg BID.'}, {'id': 'OG001', 'title': 'Cohort 1, Arm A - 6 Months to <2 Years', 'description': 'Participants with Human immunodeficiency virus (HIV-1) in Cohort 1 were initially administered single dose of fosamprenavir (FPV) 30 milligrams per kilogram (mg/kg) at single dose visit 1 (SDV1) or single dose of FPV/RTV 30/6 mg/kg (SDV2). Participants who underwent SDV2 administration began individualized regimens ranging from FPV 30 to 45/RTV 6 to 7 mg/kg twice a day (BID). Subsequently enrolled participants were administered with FPV/RTV 45/7 mg/kg BID.'}], 'classes': [{'title': 'Baseline (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'Week 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Week 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Week 108', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Week 120', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Week 132', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Week 144', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Week 156', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Week 168', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Week 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Week 192', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Week 204', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Week 216', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Week 228', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Week 240', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Week 252', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Week 264', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Week 276', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Week 288', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Week 300', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Week 312', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Week 324', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Week 336', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Week 348', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Week 360', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Week 372', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Week 384', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Week 396', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Week 408', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Week 420', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Week 432', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Week 444', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Week 456', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Week 468', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Week 480', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Week 492', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Week 504', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Week 516', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Week 528', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Week 540', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Week 552', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Week 564', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Week 576', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Week 588', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Week 600', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Week 612', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Week 624', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Week 636', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Week 648', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Week 660', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Week 672', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Week 684', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (Day 1) and up to Week 684', 'description': 'Blood samples of participants were collected to measure plasma HIV-1 RNA concentrations.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat- exposed (ITT-E) Population. Only those participants with data available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2, Arm A - 4 Weeks to <6 Months', 'description': 'Participants with HIV-1 in Cohort 2 were initially administered with single dose administration of FPV/RTV 45/7 mg/kg (SDV1). The FPV/RTV dosage regimen selected for chronic dosing ranged from 30/7 mg/kg BID to 60/10 mg/kg BID. Subsequently enrolled participants were administered with FPV/RTV 45/10 mg/kg BID.'}, {'id': 'OG001', 'title': 'Cohort 1, Arm A - 6 Months to <2 Years', 'description': 'Participants with Human immunodeficiency virus (HIV-1) in Cohort 1 were initially administered single dose of fosamprenavir (FPV) 30 milligrams per kilogram (mg/kg) at single dose visit 1 (SDV1) or single dose of FPV/RTV 30/6 mg/kg (SDV2). Participants who underwent SDV2 administration began individualized regimens ranging from FPV 30 to 45/RTV 6 to 7 mg/kg twice a day (BID). Subsequently enrolled participants were administered with FPV/RTV 45/7 mg/kg BID.'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.38', 'groupId': 'OG000', 'lowerLimit': '-2.89', 'upperLimit': '-1.64'}, {'value': '-2.33', 'groupId': 'OG001', 'lowerLimit': '-2.87', 'upperLimit': '-1.95'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.11', 'groupId': 'OG000', 'lowerLimit': '-3.94', 'upperLimit': '-1.91'}, {'value': '-3.14', 'groupId': 'OG001', 'lowerLimit': '-3.58', 'upperLimit': '-2.12'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.77', 'groupId': 'OG000', 'lowerLimit': '-4.21', 'upperLimit': '-1.91'}, {'value': '-3.38', 'groupId': 'OG001', 'lowerLimit': '-3.88', 'upperLimit': '-2.39'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.72', 'groupId': 'OG000', 'lowerLimit': '-4.26', 'upperLimit': '-3.00'}, {'value': '-3.52', 'groupId': 'OG001', 'lowerLimit': '-3.90', 'upperLimit': '-2.69'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.90', 'groupId': 'OG000', 'lowerLimit': '-4.48', 'upperLimit': '-2.28'}, {'value': '-3.56', 'groupId': 'OG001', 'lowerLimit': '-3.92', 'upperLimit': '-3.12'}]}]}, {'title': 'Week 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.89', 'groupId': 'OG000', 'lowerLimit': '-4.63', 'upperLimit': '-2.45'}, {'value': '-3.12', 'groupId': 'OG001', 'lowerLimit': '-3.92', 'upperLimit': '-2.04'}]}]}, {'title': 'Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.95', 'groupId': 'OG000', 'lowerLimit': '-4.63', 'upperLimit': '-2.45'}, {'value': '-3.60', 'groupId': 'OG001', 'lowerLimit': '-3.93', 'upperLimit': '-2.69'}]}]}, {'title': 'Week 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.95', 'groupId': 'OG000', 'lowerLimit': '-4.63', 'upperLimit': '-3.11'}, {'value': '-3.62', 'groupId': 'OG001', 'lowerLimit': '-3.98', 'upperLimit': '-2.97'}]}]}, {'title': 'Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.26', 'groupId': 'OG000', 'lowerLimit': '-4.71', 'upperLimit': '-3.31'}, {'value': '-3.70', 'groupId': 'OG001', 'lowerLimit': '-3.93', 'upperLimit': '-3.00'}]}]}, {'title': 'Week 108', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.26', 'groupId': 'OG000', 'lowerLimit': '-4.71', 'upperLimit': '-3.31'}, {'value': '-3.80', 'groupId': 'OG001', 'lowerLimit': '-3.93', 'upperLimit': '-3.00'}]}]}, {'title': 'Week 120', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.12', 'groupId': 'OG000', 'lowerLimit': '-4.71', 'upperLimit': '-3.31'}, {'value': '-3.58', 'groupId': 'OG001', 'lowerLimit': '-3.90', 'upperLimit': '-2.82'}]}]}, {'title': 'Week 132', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.09', 'groupId': 'OG000', 'lowerLimit': '-4.71', 'upperLimit': '-3.31'}, {'value': '-3.52', 'groupId': 'OG001', 'lowerLimit': '-3.90', 'upperLimit': '-2.80'}]}]}, {'title': 'Week 144', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.12', 'groupId': 'OG000', 'lowerLimit': '-4.71', 'upperLimit': '-3.31'}, {'value': '-3.52', 'groupId': 'OG001', 'lowerLimit': '-3.90', 'upperLimit': '-2.95'}]}]}, {'title': 'Week 156', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.12', 'groupId': 'OG000', 'lowerLimit': '-4.71', 'upperLimit': '-3.31'}, {'value': '-3.34', 'groupId': 'OG001', 'lowerLimit': '-3.90', 'upperLimit': '-2.95'}]}]}, {'title': 'Week 168', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.95', 'groupId': 'OG000', 'lowerLimit': '-4.63', 'upperLimit': '-3.15'}, {'value': '-3.52', 'groupId': 'OG001', 'lowerLimit': '-3.90', 'upperLimit': '-2.95'}]}]}, {'title': 'Week 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.36', 'groupId': 'OG000', 'lowerLimit': '-4.71', 'upperLimit': '-3.90'}, {'value': '-3.52', 'groupId': 'OG001', 'lowerLimit': '-3.90', 'upperLimit': '-2.95'}]}]}, {'title': 'Week 192', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.28', 'groupId': 'OG000', 'lowerLimit': '-4.71', 'upperLimit': '-3.90'}, {'value': '-3.31', 'groupId': 'OG001', 'lowerLimit': '-3.90', 'upperLimit': '-2.87'}]}]}, {'title': 'Week 204', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.22', 'groupId': 'OG000', 'lowerLimit': '-4.71', 'upperLimit': '-3.00'}, {'value': '-3.52', 'groupId': 'OG001', 'lowerLimit': '-3.99', 'upperLimit': '-2.95'}]}]}, {'title': 'Week 216', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.36', 'groupId': 'OG000', 'lowerLimit': '-4.71', 'upperLimit': '-3.00'}, {'value': '-3.52', 'groupId': 'OG001', 'lowerLimit': '-3.99', 'upperLimit': '-2.95'}]}]}, {'title': 'Week 228', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.45', 'groupId': 'OG000', 'lowerLimit': '-4.85', 'upperLimit': '-3.46'}, {'value': '-3.71', 'groupId': 'OG001', 'lowerLimit': '-4.06', 'upperLimit': '-3.07'}]}]}, {'title': 'Week 240', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.22', 'groupId': 'OG000', 'lowerLimit': '-4.64', 'upperLimit': '-3.46'}, {'value': '-3.71', 'groupId': 'OG001', 'lowerLimit': '-4.06', 'upperLimit': '-3.07'}]}]}, {'title': 'Week 252', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.22', 'groupId': 'OG000', 'lowerLimit': '-4.64', 'upperLimit': '-3.46'}, {'value': '-3.71', 'groupId': 'OG001', 'lowerLimit': '-4.06', 'upperLimit': '-3.07'}]}]}, {'title': 'Week 264', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.22', 'groupId': 'OG000', 'lowerLimit': '-4.64', 'upperLimit': '-3.46'}, {'value': '-3.71', 'groupId': 'OG001', 'lowerLimit': '-4.06', 'upperLimit': '-3.07'}]}]}, {'title': 'Week 276', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.22', 'groupId': 'OG000', 'lowerLimit': '-4.64', 'upperLimit': '-3.46'}, {'value': '-3.71', 'groupId': 'OG001', 'lowerLimit': '-4.06', 'upperLimit': '-3.07'}]}]}, {'title': 'Week 288', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.22', 'groupId': 'OG000', 'lowerLimit': '-4.64', 'upperLimit': '-3.56'}, {'value': '-3.71', 'groupId': 'OG001', 'lowerLimit': '-4.06', 'upperLimit': '-2.94'}]}]}, {'title': 'Week 300', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.22', 'groupId': 'OG000', 'lowerLimit': '-4.64', 'upperLimit': '-3.56'}, {'value': '-3.80', 'groupId': 'OG001', 'lowerLimit': '-4.07', 'upperLimit': '-3.29'}]}]}, {'title': 'Week 312', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.05', 'groupId': 'OG000', 'lowerLimit': '-4.61', 'upperLimit': '-2.25'}, {'value': '-3.98', 'groupId': 'OG001', 'lowerLimit': '-4.07', 'upperLimit': '-3.36'}]}]}, {'title': 'Week 324', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.01', 'groupId': 'OG000', 'lowerLimit': '-4.65', 'upperLimit': '-3.10'}, {'value': '-3.87', 'groupId': 'OG001', 'lowerLimit': '-4.07', 'upperLimit': '-3.36'}]}]}, {'title': 'Week 336', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.09', 'groupId': 'OG000', 'lowerLimit': '-4.81', 'upperLimit': '-3.10'}, {'value': '-3.62', 'groupId': 'OG001', 'lowerLimit': '-4.13', 'upperLimit': '-3.05'}]}]}, {'title': 'Week 348', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.33', 'groupId': 'OG000', 'lowerLimit': '-4.81', 'upperLimit': '-3.10'}, {'value': '-3.36', 'groupId': 'OG001', 'lowerLimit': '-3.99', 'upperLimit': '-3.05'}]}]}, {'title': 'Week 360', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.09', 'groupId': 'OG000', 'lowerLimit': '-4.81', 'upperLimit': '-3.10'}, {'value': '-3.62', 'groupId': 'OG001', 'lowerLimit': '-4.13', 'upperLimit': '-3.05'}]}]}, {'title': 'Week 372', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.09', 'groupId': 'OG000', 'lowerLimit': '-4.81', 'upperLimit': '-3.10'}, {'value': '-3.36', 'groupId': 'OG001', 'lowerLimit': '-4.13', 'upperLimit': '-2.79'}]}]}, {'title': 'Week 384', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.01', 'groupId': 'OG000', 'lowerLimit': '-4.65', 'upperLimit': '-3.10'}, {'value': '-3.15', 'groupId': 'OG001', 'lowerLimit': '-4.13', 'upperLimit': '-3.05'}]}]}, {'title': 'Week 396', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.09', 'groupId': 'OG000', 'lowerLimit': '-4.81', 'upperLimit': '-3.10'}, {'value': '-3.62', 'groupId': 'OG001', 'lowerLimit': '-4.13', 'upperLimit': '-3.05'}]}]}, {'title': 'Week 408', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.09', 'groupId': 'OG000', 'lowerLimit': '-4.81', 'upperLimit': '-3.10'}, {'value': '-3.62', 'groupId': 'OG001', 'lowerLimit': '-4.13', 'upperLimit': '-3.05'}]}]}, {'title': 'Week 420', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.09', 'groupId': 'OG000', 'lowerLimit': '-4.65', 'upperLimit': '-3.10'}, {'value': '-3.62', 'groupId': 'OG001', 'lowerLimit': '-4.13', 'upperLimit': '-3.05'}]}]}, {'title': 'Week 432', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.33', 'groupId': 'OG000', 'lowerLimit': '-4.81', 'upperLimit': '-3.10'}, {'value': '-3.62', 'groupId': 'OG001', 'lowerLimit': '-4.13', 'upperLimit': '-3.05'}]}]}, {'title': 'Week 444', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.04', 'groupId': 'OG000', 'lowerLimit': '-4.65', 'upperLimit': '-2.64'}, {'value': '-3.62', 'groupId': 'OG001', 'lowerLimit': '-4.13', 'upperLimit': '-3.05'}]}]}, {'title': 'Week 456', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.09', 'groupId': 'OG000', 'lowerLimit': '-4.65', 'upperLimit': '-3.10'}, {'value': '-3.62', 'groupId': 'OG001', 'lowerLimit': '-4.13', 'upperLimit': '-3.05'}]}]}, {'title': 'Week 468', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.09', 'groupId': 'OG000', 'lowerLimit': '-4.65', 'upperLimit': '-3.10'}, {'value': '-3.62', 'groupId': 'OG001', 'lowerLimit': '-4.13', 'upperLimit': '-3.05'}]}]}, {'title': 'Week 480', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.09', 'groupId': 'OG000', 'lowerLimit': '-4.65', 'upperLimit': '-3.10'}, {'value': '-3.62', 'groupId': 'OG001', 'lowerLimit': '-4.13', 'upperLimit': '-3.05'}]}]}, {'title': 'Week 492', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.55', 'groupId': 'OG000', 'lowerLimit': '-4.61', 'upperLimit': '-2.50'}, {'value': '-3.62', 'groupId': 'OG001', 'lowerLimit': '-4.13', 'upperLimit': '-3.05'}]}]}, {'title': 'Week 504', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.09', 'groupId': 'OG000', 'lowerLimit': '-4.65', 'upperLimit': '-3.10'}, {'value': '-3.62', 'groupId': 'OG001', 'lowerLimit': '-4.13', 'upperLimit': '-3.05'}]}]}, {'title': 'Week 516', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.09', 'groupId': 'OG000', 'lowerLimit': '-4.65', 'upperLimit': '-3.10'}, {'value': '-3.62', 'groupId': 'OG001', 'lowerLimit': '-4.13', 'upperLimit': '-3.05'}]}]}, {'title': 'Week 528', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.09', 'groupId': 'OG000', 'lowerLimit': '-4.65', 'upperLimit': '-3.10'}, {'value': '-3.80', 'groupId': 'OG001', 'lowerLimit': '-4.13', 'upperLimit': '-3.05'}]}]}, {'title': 'Week 540', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.09', 'groupId': 'OG000', 'lowerLimit': '-4.65', 'upperLimit': '-3.10'}, {'value': '-3.99', 'groupId': 'OG001', 'lowerLimit': '-4.13', 'upperLimit': '-3.62'}]}]}, {'title': 'Week 552', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.09', 'groupId': 'OG000', 'lowerLimit': '-4.65', 'upperLimit': '-3.10'}, {'value': '-3.99', 'groupId': 'OG001', 'lowerLimit': '-4.13', 'upperLimit': '-3.62'}]}]}, {'title': 'Week 564', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.28', 'groupId': 'OG000', 'lowerLimit': '-4.65', 'upperLimit': '-3.10'}, {'value': '-3.99', 'groupId': 'OG001', 'lowerLimit': '-4.13', 'upperLimit': '-3.62'}]}]}, {'title': 'Week 576', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.04', 'groupId': 'OG000', 'lowerLimit': '-4.65', 'upperLimit': '-3.10'}, {'value': '-3.99', 'groupId': 'OG001', 'lowerLimit': '-4.13', 'upperLimit': '-3.62'}]}]}, {'title': 'Week 588', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.04', 'groupId': 'OG000', 'lowerLimit': '-4.65', 'upperLimit': '-3.10'}, {'value': '-3.99', 'groupId': 'OG001', 'lowerLimit': '-4.13', 'upperLimit': '-3.62'}]}]}, {'title': 'Week 600', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.55', 'groupId': 'OG000', 'lowerLimit': '-4.09', 'upperLimit': '-1.53'}, {'value': '-3.99', 'groupId': 'OG001', 'lowerLimit': '-4.56', 'upperLimit': '-3.62'}]}]}, {'title': 'Week 612', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.09', 'groupId': 'OG000', 'lowerLimit': '-4.65', 'upperLimit': '-4.00'}, {'value': '-3.99', 'groupId': 'OG001', 'lowerLimit': '-4.56', 'upperLimit': '-3.62'}]}]}, {'title': 'Week 624', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.09', 'groupId': 'OG000', 'lowerLimit': '-4.65', 'upperLimit': '-4.00'}, {'value': '-3.99', 'groupId': 'OG001', 'lowerLimit': '-4.56', 'upperLimit': '-3.62'}]}]}, {'title': 'Week 636', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.00', 'groupId': 'OG000', 'lowerLimit': '-4.99', 'upperLimit': '-4.00'}, {'value': '-4.27', 'groupId': 'OG001', 'lowerLimit': '-4.56', 'upperLimit': '-3.99'}]}]}, {'title': 'Week 648', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.00', 'groupId': 'OG000', 'lowerLimit': '-4.00', 'upperLimit': '-4.00'}, {'value': '-4.27', 'groupId': 'OG001', 'lowerLimit': '-4.56', 'upperLimit': '-3.99'}]}]}, {'title': 'Week 660', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.09', 'groupId': 'OG000', 'lowerLimit': '-4.09', 'upperLimit': '-4.09'}, {'value': '-4.27', 'groupId': 'OG001', 'lowerLimit': '-4.56', 'upperLimit': '-3.99'}]}]}, {'title': 'Week 672', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.27', 'groupId': 'OG001', 'lowerLimit': '-4.56', 'upperLimit': '-3.99'}]}]}, {'title': 'Week 684', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.99', 'groupId': 'OG001', 'lowerLimit': '-3.99', 'upperLimit': '-3.99'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (Day 1) and up to Week 684', 'description': 'Blood samples of participants were collected to measure plasma HIV-1 RNA copies. Baseline value was defined as the value observed at the day 1 visit or if this value is missing the last value observed before the start of investigational product. Change from baseline value was defined as post-dose value minus baseline value.', 'unitOfMeasure': 'Log10 copies/milliliter', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat-exposed (ITT-E) Population. Only those participants with data available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2, Arm A - 4 Weeks to <6 Months', 'description': 'Participants with HIV-1 in Cohort 2 were initially administered with single dose administration of FPV/RTV 45/7 mg/kg (SDV1). The FPV/RTV dosage regimen selected for chronic dosing ranged from 30/7 mg/kg BID to 60/10 mg/kg BID. Subsequently enrolled participants were administered with FPV/RTV 45/10 mg/kg BID.'}, {'id': 'OG001', 'title': 'Cohort 1, Arm A - 6 Months to <2 Years', 'description': 'Participants with Human immunodeficiency virus (HIV-1) in Cohort 1 were initially administered single dose of fosamprenavir (FPV) 30 milligrams per kilogram (mg/kg) at single dose visit 1 (SDV1) or single dose of FPV/RTV 30/6 mg/kg (SDV2). Participants who underwent SDV2 administration began individualized regimens ranging from FPV 30 to 45/RTV 6 to 7 mg/kg twice a day (BID). Subsequently enrolled participants were administered with FPV/RTV 45/7 mg/kg BID.'}], 'classes': [{'title': 'Baseline (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1378', 'groupId': 'OG000', 'lowerLimit': '950', 'upperLimit': '1690'}, {'value': '1120', 'groupId': 'OG001', 'lowerLimit': '873.5', 'upperLimit': '1827.5'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1610', 'groupId': 'OG000', 'lowerLimit': '1170', 'upperLimit': '2520'}, {'value': '1734.5', 'groupId': 'OG001', 'lowerLimit': '1290', 'upperLimit': '2287'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1405', 'groupId': 'OG000', 'lowerLimit': '1107', 'upperLimit': '1757'}, {'value': '1822', 'groupId': 'OG001', 'lowerLimit': '1120', 'upperLimit': '2392'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1595', 'groupId': 'OG000', 'lowerLimit': '1320', 'upperLimit': '1910'}, {'value': '1475.5', 'groupId': 'OG001', 'lowerLimit': '1223', 'upperLimit': '2178'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1780', 'groupId': 'OG000', 'lowerLimit': '1620', 'upperLimit': '2410'}, {'value': '1523', 'groupId': 'OG001', 'lowerLimit': '1200', 'upperLimit': '2069'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1690', 'groupId': 'OG000', 'lowerLimit': '1150', 'upperLimit': '2080'}, {'value': '1602', 'groupId': 'OG001', 'lowerLimit': '1035', 'upperLimit': '2345.5'}]}]}, {'title': 'Week 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1890', 'groupId': 'OG000', 'lowerLimit': '1544', 'upperLimit': '1980'}, {'value': '1311', 'groupId': 'OG001', 'lowerLimit': '944', 'upperLimit': '1962'}]}]}, {'title': 'Week 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1407', 'groupId': 'OG000', 'lowerLimit': '1172', 'upperLimit': '1890'}, {'value': '1667', 'groupId': 'OG001', 'lowerLimit': '930', 'upperLimit': '1883'}]}]}, {'title': 'Week 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1560', 'groupId': 'OG000', 'lowerLimit': '1280', 'upperLimit': '2044'}, {'value': '1490.5', 'groupId': 'OG001', 'lowerLimit': '1307.5', 'upperLimit': '2516.5'}]}]}, {'title': 'Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1530', 'groupId': 'OG000', 'lowerLimit': '1055', 'upperLimit': '1990'}, {'value': '1460', 'groupId': 'OG001', 'lowerLimit': '1260', 'upperLimit': '1730'}]}]}, {'title': 'Week 108', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1440', 'groupId': 'OG000', 'lowerLimit': '1220', 'upperLimit': '1820'}, {'value': '1343.5', 'groupId': 'OG001', 'lowerLimit': '1149', 'upperLimit': '1610'}]}]}, {'title': 'Week 120', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1480', 'groupId': 'OG000', 'lowerLimit': '1160', 'upperLimit': '1940'}, {'value': '1148.5', 'groupId': 'OG001', 'lowerLimit': '905.5', 'upperLimit': '1735'}]}]}, {'title': 'Week 132', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1285', 'groupId': 'OG000', 'lowerLimit': '1130', 'upperLimit': '1430'}, {'value': '1440', 'groupId': 'OG001', 'lowerLimit': '1033', 'upperLimit': '1810'}]}]}, {'title': 'Week 144', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1250', 'groupId': 'OG000', 'lowerLimit': '935', 'upperLimit': '1480'}, {'value': '1562', 'groupId': 'OG001', 'lowerLimit': '1141', 'upperLimit': '1730'}]}]}, {'title': 'Week 156', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1422', 'groupId': 'OG000', 'lowerLimit': '990', 'upperLimit': '1600'}, {'value': '1307', 'groupId': 'OG001', 'lowerLimit': '1147', 'upperLimit': '1719'}]}]}, {'title': 'Week 168', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1550', 'groupId': 'OG000', 'lowerLimit': '1150', 'upperLimit': '1700'}, {'value': '1236', 'groupId': 'OG001', 'lowerLimit': '883', 'upperLimit': '1358'}]}]}, {'title': 'Week 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1331.5', 'groupId': 'OG000', 'lowerLimit': '983', 'upperLimit': '1700'}, {'value': '978', 'groupId': 'OG001', 'lowerLimit': '939', 'upperLimit': '1640'}]}]}, {'title': 'Week 192', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1339', 'groupId': 'OG000', 'lowerLimit': '944.5', 'upperLimit': '1644'}, {'value': '1327', 'groupId': 'OG001', 'lowerLimit': '877', 'upperLimit': '1559'}]}]}, {'title': 'Week 204', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1160', 'groupId': 'OG000', 'lowerLimit': '776.5', 'upperLimit': '1690'}, {'value': '1082', 'groupId': 'OG001', 'lowerLimit': '960', 'upperLimit': '1650'}]}]}, {'title': 'Week 216', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1336', 'groupId': 'OG000', 'lowerLimit': '979.5', 'upperLimit': '1451.5'}, {'value': '909', 'groupId': 'OG001', 'lowerLimit': '809', 'upperLimit': '1497'}]}]}, {'title': 'Week 228', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1136', 'groupId': 'OG000', 'lowerLimit': '910.5', 'upperLimit': '1345'}, {'value': '1106', 'groupId': 'OG001', 'lowerLimit': '842', 'upperLimit': '1425'}]}]}, {'title': 'Week 240', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1132.5', 'groupId': 'OG000', 'lowerLimit': '736.5', 'upperLimit': '1464'}, {'value': '1067', 'groupId': 'OG001', 'lowerLimit': '743.5', 'upperLimit': '1232.5'}]}]}, {'title': 'Week 252', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1379', 'groupId': 'OG000', 'lowerLimit': '927', 'upperLimit': '1592'}, {'value': '1098.5', 'groupId': 'OG001', 'lowerLimit': '796', 'upperLimit': '1454'}]}]}, {'title': 'Week 264', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1109', 'groupId': 'OG000', 'lowerLimit': '990', 'upperLimit': '1326'}, {'value': '853', 'groupId': 'OG001', 'lowerLimit': '777', 'upperLimit': '1421.5'}]}]}, {'title': 'Week 276', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1180.5', 'groupId': 'OG000', 'lowerLimit': '889.5', 'upperLimit': '1336'}, {'value': '970', 'groupId': 'OG001', 'lowerLimit': '803.5', 'upperLimit': '1238'}]}]}, {'title': 'Week 288', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1063', 'groupId': 'OG000', 'lowerLimit': '737.5', 'upperLimit': '1330'}, {'value': '911.5', 'groupId': 'OG001', 'lowerLimit': '832', 'upperLimit': '1140.5'}]}]}, {'title': 'Week 300', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1062', 'groupId': 'OG000', 'lowerLimit': '659', 'upperLimit': '1249'}, {'value': '990', 'groupId': 'OG001', 'lowerLimit': '571.5', 'upperLimit': '1188.5'}]}]}, {'title': 'Week 312', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '924', 'groupId': 'OG000', 'lowerLimit': '775', 'upperLimit': '1199.5'}, {'value': '928.5', 'groupId': 'OG001', 'lowerLimit': '858', 'upperLimit': '1220'}]}]}, {'title': 'Week 324', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '980', 'groupId': 'OG000', 'lowerLimit': '770', 'upperLimit': '1310'}, {'value': '1242', 'groupId': 'OG001', 'lowerLimit': '840.4', 'upperLimit': '1420'}]}]}, {'title': 'Week 336', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '856', 'groupId': 'OG000', 'lowerLimit': '670', 'upperLimit': '1160'}, {'value': '1160', 'groupId': 'OG001', 'lowerLimit': '711', 'upperLimit': '1276'}]}]}, {'title': 'Week 348', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1030', 'groupId': 'OG000', 'lowerLimit': '840', 'upperLimit': '1365'}, {'value': '976', 'groupId': 'OG001', 'lowerLimit': '887', 'upperLimit': '1264'}]}]}, {'title': 'Week 360', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1151', 'groupId': 'OG000', 'lowerLimit': '839', 'upperLimit': '1240'}, {'value': '962', 'groupId': 'OG001', 'lowerLimit': '759', 'upperLimit': '1310'}]}]}, {'title': 'Week 372', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1051', 'groupId': 'OG000', 'lowerLimit': '700', 'upperLimit': '1070'}, {'value': '926', 'groupId': 'OG001', 'lowerLimit': '637', 'upperLimit': '1545'}]}]}, {'title': 'Week 384', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '950', 'groupId': 'OG000', 'lowerLimit': '800', 'upperLimit': '1158'}, {'value': '884', 'groupId': 'OG001', 'lowerLimit': '731', 'upperLimit': '1281'}]}]}, {'title': 'Week 396', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '971', 'groupId': 'OG000', 'lowerLimit': '805', 'upperLimit': '1110'}, {'value': '900', 'groupId': 'OG001', 'lowerLimit': '630', 'upperLimit': '1148'}]}]}, {'title': 'Week 408', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1005', 'groupId': 'OG000', 'lowerLimit': '770', 'upperLimit': '1107'}, {'value': '938.5', 'groupId': 'OG001', 'lowerLimit': '578', 'upperLimit': '1106'}]}]}, {'title': 'Week 420', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '840', 'groupId': 'OG000', 'lowerLimit': '768', 'upperLimit': '1130'}, {'value': '850', 'groupId': 'OG001', 'lowerLimit': '705', 'upperLimit': '1007'}]}]}, {'title': 'Week 432', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '940.5', 'groupId': 'OG000', 'lowerLimit': '705', 'upperLimit': '1138'}, {'value': '918', 'groupId': 'OG001', 'lowerLimit': '754', 'upperLimit': '1121'}]}]}, {'title': 'Week 444', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '811', 'groupId': 'OG000', 'lowerLimit': '745.5', 'upperLimit': '990'}, {'value': '860', 'groupId': 'OG001', 'lowerLimit': '816', 'upperLimit': '1139'}]}]}, {'title': 'Week 456', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1003', 'groupId': 'OG000', 'lowerLimit': '712', 'upperLimit': '1143'}, {'value': '832', 'groupId': 'OG001', 'lowerLimit': '701', 'upperLimit': '1080'}]}]}, {'title': 'Week 468', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '910', 'groupId': 'OG000', 'lowerLimit': '665', 'upperLimit': '1211'}, {'value': '863', 'groupId': 'OG001', 'lowerLimit': '715', 'upperLimit': '1024'}]}]}, {'title': 'Week 480', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1063.5', 'groupId': 'OG000', 'lowerLimit': '838', 'upperLimit': '1270'}, {'value': '1010', 'groupId': 'OG001', 'lowerLimit': '760', 'upperLimit': '1226'}]}]}, {'title': 'Week 492', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '839', 'groupId': 'OG000', 'lowerLimit': '780', 'upperLimit': '970'}, {'value': '930', 'groupId': 'OG001', 'lowerLimit': '823', 'upperLimit': '1139'}]}]}, {'title': 'Week 504', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '887', 'groupId': 'OG000', 'lowerLimit': '805', 'upperLimit': '1013'}, {'value': '910', 'groupId': 'OG001', 'lowerLimit': '777', 'upperLimit': '1265'}]}]}, {'title': 'Week 516', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '776', 'groupId': 'OG000', 'lowerLimit': '699.5', 'upperLimit': '952'}, {'value': '994', 'groupId': 'OG001', 'lowerLimit': '793', 'upperLimit': '1121'}]}]}, {'title': 'Week 528', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '860', 'groupId': 'OG000', 'lowerLimit': '690', 'upperLimit': '1070'}, {'value': '892', 'groupId': 'OG001', 'lowerLimit': '732', 'upperLimit': '1136'}]}]}, {'title': 'Week 540', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '851', 'groupId': 'OG000', 'lowerLimit': '720', 'upperLimit': '976'}, {'value': '877', 'groupId': 'OG001', 'lowerLimit': '798', 'upperLimit': '1040'}]}]}, {'title': 'Week 552', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '756', 'groupId': 'OG000', 'lowerLimit': '730', 'upperLimit': '940'}, {'value': '1000', 'groupId': 'OG001', 'lowerLimit': '941', 'upperLimit': '1080'}]}]}, {'title': 'Week 564', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '908', 'groupId': 'OG000', 'lowerLimit': '809', 'upperLimit': '1110'}, {'value': '804', 'groupId': 'OG001', 'lowerLimit': '790', 'upperLimit': '890'}]}]}, {'title': 'Week 576', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '792', 'groupId': 'OG000', 'lowerLimit': '768', 'upperLimit': '1013'}, {'value': '990', 'groupId': 'OG001', 'lowerLimit': '910', 'upperLimit': '1047'}]}]}, {'title': 'Week 588', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '873', 'groupId': 'OG000', 'lowerLimit': '750', 'upperLimit': '1018'}, {'value': '1100', 'groupId': 'OG001', 'lowerLimit': '870', 'upperLimit': '1110'}]}]}, {'title': 'Week 600', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '865.5', 'groupId': 'OG000', 'lowerLimit': '813', 'upperLimit': '936'}, {'value': '717', 'groupId': 'OG001', 'lowerLimit': '506', 'upperLimit': '928'}]}]}, {'title': 'Week 612', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '720', 'groupId': 'OG000', 'lowerLimit': '714', 'upperLimit': '800'}, {'value': '949', 'groupId': 'OG001', 'lowerLimit': '655', 'upperLimit': '1000'}]}]}, {'title': 'Week 624', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '753', 'groupId': 'OG000', 'lowerLimit': '678.5', 'upperLimit': '884.5'}, {'value': '720', 'groupId': 'OG001', 'lowerLimit': '500', 'upperLimit': '1020'}]}]}, {'title': 'Week 636', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '770', 'groupId': 'OG000', 'lowerLimit': '610', 'upperLimit': '930'}, {'value': '535', 'groupId': 'OG001', 'lowerLimit': '290', 'upperLimit': '580'}]}]}, {'title': 'Week 648', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '720', 'groupId': 'OG000', 'lowerLimit': '660', 'upperLimit': '780'}, {'value': '455', 'groupId': 'OG001', 'lowerLimit': '450', 'upperLimit': '460'}]}]}, {'title': 'Week 660', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '750', 'groupId': 'OG000', 'lowerLimit': '750', 'upperLimit': '750'}, {'value': '610', 'groupId': 'OG001', 'lowerLimit': '320', 'upperLimit': '900'}]}]}, {'title': 'Week 672', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '710', 'groupId': 'OG001', 'lowerLimit': '490', 'upperLimit': '930'}]}]}, {'title': 'Week 684', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '580', 'groupId': 'OG001', 'lowerLimit': '580', 'upperLimit': '580'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (Day 1) and up to week 684', 'description': 'Blood samples of participants were collected for the measurement of the CD4+ cells.', 'unitOfMeasure': 'Cells/cubic millimeter', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat- exposed (ITT-E) Population. Only those participants with data available at the specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Plasma FPV Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'FPV/RTV BID', 'description': 'Participants with Human immunodeficiency virus (HIV-1) of age group-6 months to \\<2 years were administered with fosamprenavir (FPV)/ritonavir (RTV) 45/7 milligrams per kilogram (mg/kg) twice a day (BID) and participants with HIV-1 of age group - 4 weeks to \\<6 months were administered with FPV/RTV 45/10 mg/kg BID. FPV/RTV BID arm also include participants who only received treatment at single dose visits (SDV).'}], 'timeFrame': 'Post -Week 48 through Week 684', 'reportingStatus': 'POSTED', 'populationDescription': 'All PK data collected through 5 July 2011 were included in the 48-week analysis results, no data was subsequently collected.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-Emergent Mutations at Virologic Failure Timepoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ART-Naive', 'description': 'Antiretroviral therapy (ART) Naive participants with HIV-1 of age group-6 months to \\<2 years were administered with FPV/RTV 45/7 mg/kg BID and participants with HIV-1 of age group - 4 weeks to \\<6 months were administered with FPV/RTV 45/10 mg/kg BID.'}, {'id': 'OG001', 'title': 'PI-Naive', 'description': 'PI-Naive participants with HIV-1 of age group-6 months to \\<2 years were administered with FPV/RTV 45/7 mg/kg BID and participants with HIV-1 of age group - 4 weeks to \\<6 months were administered with FPV/RTV 45/10 mg/kg BID.'}, {'id': 'OG002', 'title': 'PI-Experienced', 'description': 'PI-Experienced participants with HIV-1 of age group-6 months to \\<2 years were administered with FPV/RTV 45/7 mg/kg BID and participants with HIV-1 of age group - 4 weeks to \\<6 months were administered with FPV/RTV 45/10 mg/kg BID.'}], 'classes': [{'title': 'PRO, L10L/R', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'PRO, I62I/V', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 48 to Week 684', 'description': 'A blood sample was drawn from participants failing to respond to therapy, and genotyping was performed to identify the mutations present in the baseline (pre-therapy) and the sample obtained at virologic failure (VF). For each participant, the HIV-1 mutations found at the time of failure were compared with any HIV-1 mutations detected in the blood sample at baseline. New International AIDS Society-USA defined resistance mutations that developed at the time of failure were tabulated by drug class- NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor. Participants are grouped by study arm (prior therapy experience), results displayed in this table are from participants who met virologic failure criteria from Week 48 through Week 684.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'VF population included participants who failed to achieve plasma HIV-RNA\\<400 copies/mL by Week 24; or confirmed HIV-RNA rebound to \\>=400 copies/mL any time after achieving plasma HIV-RNA\\<400 copies/mL and had evaluable viral isolate genotypic data. Only participants with an HIV-1 genotype which obtained for both the baseline and the indicated time of VF points were evaluable. No participants in this time frame were PI-experienced, therefore data was not collected for the PI-Experienced Group.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-Emergent Changes in HIV-1 Phenotypic Drug Susceptibility', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ART-Naive', 'description': 'Antiretroviral therapy (ART) Naive participants with HIV-1 of age group-6 months to \\<2 years were administered with FPV/RTV 45/7 mg/kg BID and participants with HIV-1 of age group - 4 weeks to \\<6 months were administered with FPV/RTV 45/10 mg/kg BID.'}, {'id': 'OG001', 'title': 'PI-Naive', 'description': 'PI-Naive participants with HIV-1 of age group-6 months to \\<2 years were administered with FPV/RTV 45/7 mg/kg BID and participants with HIV-1 of age group - 4 weeks to \\<6 months were administered with FPV/RTV 45/10 mg/kg BID.'}, {'id': 'OG002', 'title': 'PI-Experienced', 'description': 'PI-Experienced participants with HIV-1 of age group-6 months to \\<2 years were administered with FPV/RTV 45/7 mg/kg BID and participants with HIV-1 of age group - 4 weeks to \\<6 months were administered with FPV/RTV 45/10 mg/kg BID.'}], 'classes': [{'title': 'Treatment emergent reduced NRTI drug susceptibility', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Treatment emergent reduced NNRTI drug susceptibility', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Treatment emergent reduced PI drug susceptibility', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Post-Week 48 to Week 684', 'description': 'A blood sample was drawn from participant failing to respond to therapy, and the mutations present in the virus were identified. Phenotypic resistance was assessed for virologic failure population and evaluated for Protease Inhibitors (PIs), Nucleotide reverse transcriptase inhibitors (NRTIs), and non-NRTIs (NNTRIs) using Monogram PhenoSense Assay. Virologic failure was defined as having failed to achieve a plasma HIV-RNA of \\<400 copies/mL by Week 24 or having had a confirmed HIV-RNA rebound to ≥400 c/mL at any time after achieving a plasma HIV-RNA of \\<400 c/mL.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Virological failure population includes participants who met the protocol definition of definition of virologic failure and for whom an HIV-1 phenotype was obtained at both the baseline (pre-therapy) and at the virologic failure timepoints. No participants in this time frame were PI-experienced, therefore data was not collected for the PI-Experienced Arm/Group.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 Copies Per Milliliter at Baseline and Weeks 4, 12, 24, 36, and 48 (MSD=F)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2, Arm A - 4 Weeks to <6 Months', 'description': 'Participants with HIV-1 in Cohort 2 were initially administered with single dose administration of FPV/RTV 45/7 mg/kg (SDV1). The FPV/RTV dosage regimen selected for chronic dosing ranged from 30/7 mg/kg BID to 60/10 mg/kg BID. Subsequently enrolled participants were administered with FPV/RTV 45/10 mg/kg BID.'}, {'id': 'OG001', 'title': 'Cohort 1, Arm A - 6 Months to <2 Years', 'description': 'Participants with Human immunodeficiency virus (HIV-1) in Cohort 1 were initially administered single dose of fosamprenavir (FPV) 30 milligrams per kilogram (mg/kg) at single dose visit 1 (SDV1) or single dose of FPV/RTV 30/6 mg/kg (SDV2). Participants who underwent SDV2 administration began individualized regimens ranging from FPV 30 to 45/RTV 6 to 7 mg/kg twice a day (BID). Subsequently enrolled participants were administered with FPV/RTV 45/7 mg/kg BID.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Week 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Weeks 4, 12, 24, 36, and 48', 'description': 'Blood samples of participants were collected to measure plasma HIV-1 RNA concentrations. Viral load, measured in RNA copies per milliliter of plasma, is an efficacy measure for antiretroviral drugs. In the Missing, Switch, or Discontinuation=Failure (MSD=F) analysis, participants who had missing data at or had discontinued the study prior to a certain time point or had changed their background antiretroviral regimen are classified as non-responders.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Exposed (ITT-E) Population: participants who received chronic therapy with FPV or FPV/RTV at any dose. Only those participants contributing data at the indicated time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Median Plasma HIV-1 RNA (log10 Copies/mL) at Baseline and Weeks 4, 12, 24, 36, and 48 (Observed Analysis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2, Arm A - 4 Weeks to <6 Months', 'description': 'Participants with HIV-1 in Cohort 2 were initially administered with single dose administration of FPV/RTV 45/7 mg/kg (SDV1). The FPV/RTV dosage regimen selected for chronic dosing ranged from 30/7 mg/kg BID to 60/10 mg/kg BID. Subsequently enrolled participants were administered with FPV/RTV 45/10 mg/kg BID.'}, {'id': 'OG001', 'title': 'Cohort 1, Arm A - 6 Months to <2 Years', 'description': 'Participants with Human immunodeficiency virus (HIV-1) in Cohort 1 were initially administered single dose of fosamprenavir (FPV) 30 milligrams per kilogram (mg/kg) at single dose visit 1 (SDV1) or single dose of FPV/RTV 30/6 mg/kg (SDV2). Participants who underwent SDV2 administration began individualized regimens ranging from FPV 30 to 45/RTV 6 to 7 mg/kg twice a day (BID). Subsequently enrolled participants were administered with FPV/RTV 45/7 mg/kg BID.'}], 'classes': [{'title': 'Baseline, n=26;28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.80', 'groupId': 'OG000', 'lowerLimit': '5.17', 'upperLimit': '6.30'}, {'value': '5.51', 'groupId': 'OG001', 'lowerLimit': '4.81', 'upperLimit': '5.76'}]}]}, {'title': 'Week 4, n=21;28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.29', 'groupId': 'OG000', 'lowerLimit': '2.88', 'upperLimit': '4.05'}, {'value': '2.88', 'groupId': 'OG001', 'lowerLimit': '2.65', 'upperLimit': '3.19'}]}]}, {'title': 'Week 12, n=22;27', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.28', 'groupId': 'OG000', 'lowerLimit': '1.69', 'upperLimit': '3.11'}, {'value': '2.07', 'groupId': 'OG001', 'lowerLimit': '1.69', 'upperLimit': '2.72'}]}]}, {'title': 'Week 24, n=22;25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.69', 'groupId': 'OG000', 'lowerLimit': '1.69', 'upperLimit': '2.27'}, {'value': '1.74', 'groupId': 'OG001', 'lowerLimit': '1.69', 'upperLimit': '2.34'}]}]}, {'title': 'Week 36, n=21;25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.69', 'groupId': 'OG000', 'lowerLimit': '1.69', 'upperLimit': '2.33'}, {'value': '1.69', 'groupId': 'OG001', 'lowerLimit': '1.69', 'upperLimit': '1.80'}]}]}, {'title': 'Week 48, n=18;24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.69', 'groupId': 'OG000', 'lowerLimit': '1.69', 'upperLimit': '1.69'}, {'value': '1.69', 'groupId': 'OG001', 'lowerLimit': '1.69', 'upperLimit': '1.72'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Weeks 4, 12, 24, 36, and 48', 'description': 'Blood samples of participants were collected to assess the decrease in the number of HIV-1 RNA copies.', 'unitOfMeasure': 'log10 copies/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT-E Population. In the observed analysis, data are presented for the number of participants still enrolled in the study at a certain time point.'}, {'type': 'SECONDARY', 'title': 'Median Change From Baseline in Plasma HIV-1 RNA (log10 Copies/mL) at Weeks 4, 12, 24, 36, and 48 (Observed Analysis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2, Arm A - 4 Weeks to <6 Months', 'description': 'Participants with HIV-1 in Cohort 2 were initially administered with single dose administration of FPV/RTV 45/7 mg/kg (SDV1). The FPV/RTV dosage regimen selected for chronic dosing ranged from 30/7 mg/kg BID to 60/10 mg/kg BID. Subsequently enrolled participants were administered with FPV/RTV 45/10 mg/kg BID.'}, {'id': 'OG001', 'title': 'Cohort 1, Arm A - 6 Months to <2 Years', 'description': 'Participants with Human immunodeficiency virus (HIV-1) in Cohort 1 were initially administered single dose of fosamprenavir (FPV) 30 milligrams per kilogram (mg/kg) at single dose visit 1 (SDV1) or single dose of FPV/RTV 30/6 mg/kg (SDV2). Participants who underwent SDV2 administration began individualized regimens ranging from FPV 30 to 45/RTV 6 to 7 mg/kg twice a day (BID). Subsequently enrolled participants were administered with FPV/RTV 45/7 mg/kg BID.'}], 'classes': [{'title': 'Week 4, n=21;28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.38', 'groupId': 'OG000', 'lowerLimit': '-2.89', 'upperLimit': '-1.64'}, {'value': '-2.33', 'groupId': 'OG001', 'lowerLimit': '-2.87', 'upperLimit': '-1.95'}]}]}, {'title': 'Week 12, n=22;27', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.11', 'groupId': 'OG000', 'lowerLimit': '-3.94', 'upperLimit': '-1.94'}, {'value': '-3.14', 'groupId': 'OG001', 'lowerLimit': '-3.58', 'upperLimit': '-2.12'}]}]}, {'title': 'Week 24, n=22;25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.77', 'groupId': 'OG000', 'lowerLimit': '-4.21', 'upperLimit': '-1.91'}, {'value': '-3.38', 'groupId': 'OG001', 'lowerLimit': '-3.88', 'upperLimit': '-2.39'}]}]}, {'title': 'Week 36, n=21;25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.72', 'groupId': 'OG000', 'lowerLimit': '-4.26', 'upperLimit': '-3.00'}, {'value': '-3.52', 'groupId': 'OG001', 'lowerLimit': '-3.90', 'upperLimit': '-2.69'}]}]}, {'title': 'Week 48, n=18;24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.90', 'groupId': 'OG000', 'lowerLimit': '-4.48', 'upperLimit': '-2.28'}, {'value': '-3.56', 'groupId': 'OG001', 'lowerLimit': '-3.92', 'upperLimit': '-3.12'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Weeks 4, 12, 24, 36, and 48', 'description': 'Blood samples of participants were collected to assess the decrease in the number of HIV-1 RNA copies. Change from Baseline in plasma HIV-1 RNA was calculated as the value at the indicated time point minus the value at Baseline.', 'unitOfMeasure': 'log10 copies/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT-E Population. In the observed analysis, data are presented for the number of participants still enrolled in the study at a certain time point.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With at Least a 1.0 log10 HIV-1 RNA Decrease From Baseline at Weeks 4, 12, 24, 36, and 48 (MSD=F Analysis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2, Arm A - 4 Weeks to <6 Months', 'description': 'Participants with HIV-1 in Cohort 2 were initially administered with single dose administration of FPV/RTV 45/7 mg/kg (SDV1). The FPV/RTV dosage regimen selected for chronic dosing ranged from 30/7 mg/kg BID to 60/10 mg/kg BID. Subsequently enrolled participants were administered with FPV/RTV 45/10 mg/kg BID.'}, {'id': 'OG001', 'title': 'Cohort 1, Arm A - 6 Months to <2 Years', 'description': 'Participants with Human immunodeficiency virus (HIV-1) in Cohort 1 were initially administered single dose of fosamprenavir (FPV) 30 milligrams per kilogram (mg/kg) at single dose visit 1 (SDV1) or single dose of FPV/RTV 30/6 mg/kg (SDV2). Participants who underwent SDV2 administration began individualized regimens ranging from FPV 30 to 45/RTV 6 to 7 mg/kg twice a day (BID). Subsequently enrolled participants were administered with FPV/RTV 45/7 mg/kg BID.'}], 'classes': [{'title': 'Week 4', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': 'Week 36', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Weeks 4, 12, 24, 36, and 48', 'description': 'Blood samples of participants were collected to assess the decrease in the number of HIV-1 RNA copies. In the MSD=F analysis, participants who had missing data at or had discontinued the study prior to a certain time point or had changed their background antiretroviral regimen are classified as non-responders.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT-E Population. Only those participants contributing data at the indicated time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Median Percent Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and at Weeks 4, 12, 24, 36, and 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2, Arm A - 4 Weeks to <6 Months', 'description': 'Participants with HIV-1 in Cohort 2 were initially administered with single dose administration of FPV/RTV 45/7 mg/kg (SDV1). The FPV/RTV dosage regimen selected for chronic dosing ranged from 30/7 mg/kg BID to 60/10 mg/kg BID. Subsequently enrolled participants were administered with FPV/RTV 45/10 mg/kg BID.'}, {'id': 'OG001', 'title': 'Cohort 1, Arm A - 6 Months to <2 Years', 'description': 'Participants with Human immunodeficiency virus (HIV-1) in Cohort 1 were initially administered single dose of fosamprenavir (FPV) 30 milligrams per kilogram (mg/kg) at single dose visit 1 (SDV1) or single dose of FPV/RTV 30/6 mg/kg (SDV2). Participants who underwent SDV2 administration began individualized regimens ranging from FPV 30 to 45/RTV 6 to 7 mg/kg twice a day (BID). Subsequently enrolled participants were administered with FPV/RTV 45/7 mg/kg BID.'}], 'classes': [{'title': 'Baseline, n=23;28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000', 'lowerLimit': '20', 'upperLimit': '36'}, {'value': '25', 'groupId': 'OG001', 'lowerLimit': '18', 'upperLimit': '31'}]}]}, {'title': 'Week 4, n=23;28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000', 'lowerLimit': '23', 'upperLimit': '37'}, {'value': '27.5', 'groupId': 'OG001', 'lowerLimit': '20.5', 'upperLimit': '35'}]}]}, {'title': 'Week 12, n=22;27', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27.5', 'groupId': 'OG000', 'lowerLimit': '23.6', 'upperLimit': '35'}, {'value': '32', 'groupId': 'OG001', 'lowerLimit': '23', 'upperLimit': '39.4'}]}]}, {'title': 'Week 24, n=22;26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '31.5', 'groupId': 'OG000', 'lowerLimit': '27.2', 'upperLimit': '34'}, {'value': '32.8', 'groupId': 'OG001', 'lowerLimit': '26', 'upperLimit': '37.7'}]}]}, {'title': 'Week 36, n=21;25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000', 'lowerLimit': '26', 'upperLimit': '38.8'}, {'value': '29.5', 'groupId': 'OG001', 'lowerLimit': '28', 'upperLimit': '36.5'}]}]}, {'title': 'Week 48, n=18;24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000', 'lowerLimit': '25', 'upperLimit': '32'}, {'value': '31.6', 'groupId': 'OG001', 'lowerLimit': '23', 'upperLimit': '38'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Weeks 4, 12, 24, 36, and 48', 'description': 'Blood samples of participants were collected for the measurement of the percentage of total lymphocytes that are CD4+ cells. Observed analysis was used for the summary of proportion endpoints using viral load data. CD4+ cells are white blood cells that are important in fighting infection. HIV infects CD4+ cells, replicates in them, and destroys them. A CD4+ cell count provides a measure of the status of the immune system and to what extent it is affected by HIV.', 'unitOfMeasure': 'Percentage of cells', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT-E Population. Only those participants contributing data at the indicated time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Median Percent Change From Baseline in CD4+ Cell Count at Weeks 4, 12, 24, 36, and 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2, Arm A - 4 Weeks to <6 Months', 'description': 'Participants with HIV-1 in Cohort 2 were initially administered with single dose administration of FPV/RTV 45/7 mg/kg (SDV1). The FPV/RTV dosage regimen selected for chronic dosing ranged from 30/7 mg/kg BID to 60/10 mg/kg BID. Subsequently enrolled participants were administered with FPV/RTV 45/10 mg/kg BID.'}, {'id': 'OG001', 'title': 'Cohort 1, Arm A - 6 Months to <2 Years', 'description': 'Participants with Human immunodeficiency virus (HIV-1) in Cohort 1 were initially administered single dose of fosamprenavir (FPV) 30 milligrams per kilogram (mg/kg) at single dose visit 1 (SDV1) or single dose of FPV/RTV 30/6 mg/kg (SDV2). Participants who underwent SDV2 administration began individualized regimens ranging from FPV 30 to 45/RTV 6 to 7 mg/kg twice a day (BID). Subsequently enrolled participants were administered with FPV/RTV 45/7 mg/kg BID.'}], 'classes': [{'title': 'Week 4, n=20;28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '-1', 'upperLimit': '7.5'}, {'value': '3.4', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '6.3'}]}]}, {'title': 'Week 12, n=19;27', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '8'}, {'value': '6', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '8'}]}]}, {'title': 'Week 24, n=19;26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000', 'lowerLimit': '-1', 'upperLimit': '12'}, {'value': '6', 'groupId': 'OG001', 'lowerLimit': '2.6', 'upperLimit': '11'}]}]}, {'title': 'Week 36, n=18;25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '12'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '8'}]}]}, {'title': 'Week 48, n=15;24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '-7', 'upperLimit': '9'}, {'value': '4.7', 'groupId': 'OG001', 'lowerLimit': '2.2', 'upperLimit': '8.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Weeks 4, 12, 24, 36, and 48', 'description': 'Blood samples of participants were collected for the measurement of the percentage of total lymphocytes that are CD4+ cells. Observed analysis was used for the summary of proportion endpoints using viral load data. Change from Baseline in percentage was calculated as the value at indicated time points minus the value at Baseline.', 'unitOfMeasure': 'Percentage of cells', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT-E Population. Only those participants contributing data at the indicated time points were analyzed. Not all participants had values at both baseline and the indicated time points; thus, change from baseline could not be calculated for all participants.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With the Indicated Virological Outcome at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2, Arm A - 4 Weeks to <6 Months', 'description': 'Participants with HIV-1 in Cohort 2 were initially administered with single dose administration of FPV/RTV 45/7 mg/kg (SDV1). The FPV/RTV dosage regimen selected for chronic dosing ranged from 30/7 mg/kg BID to 60/10 mg/kg BID. Subsequently enrolled participants were administered with FPV/RTV 45/10 mg/kg BID.'}, {'id': 'OG001', 'title': 'Cohort 1, Arm A - 6 Months to <2 Years', 'description': 'Participants with Human immunodeficiency virus (HIV-1) in Cohort 1 were initially administered single dose of fosamprenavir (FPV) 30 milligrams per kilogram (mg/kg) at single dose visit 1 (SDV1) or single dose of FPV/RTV 30/6 mg/kg (SDV2). Participants who underwent SDV2 administration began individualized regimens ranging from FPV 30 to 45/RTV 6 to 7 mg/kg twice a day (BID). Subsequently enrolled participants were administered with FPV/RTV 45/7 mg/kg BID.'}], 'classes': [{'title': 'Virological (V) success', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'V failure (1)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'V failure (2)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'V failure (3)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'V failure (4)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'No V data at Week 48 (a)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'No V data at Week 48 (b)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48', 'description': 'Blood samples of participants were collected to measure plasma HIV-1 RNA concentrations. PI-exp = PI-experienced. Virologic success was defined as plasma HIV-1 RNA \\<400 copies/mL. Virologic failure: (1) HIV-1 RNA \\>=400 copies/mL, (2) change of background antiretroviral treatment (ART), (3) discontinued study due to lack of efficacy, (4) discontinued study with last HIV-1 \\>=400 copies/mL. No virologic data at Week 48 window: (a) discontinued study due to an adverse event or death, (b) discontinued study due to other reasons (withdrew consent, loss to follow-up, moved, etc.).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT-E Population. Only those participants contributing data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Plasma Ritonavir (RTV) AUC (0-τ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FPV/RTV BID: 4 Weeks to <6 Months', 'description': 'Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day \\[BID\\]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.'}, {'id': 'OG001', 'title': 'FPV/RTV BID: 6 Months to <2 Years', 'description': 'Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day \\[BID\\]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.'}], 'classes': [{'title': '7 mg/kg BID; n=2, 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.921', 'comment': 'The 95% CI is not available because the number of participants analyzed is 2.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '7.363', 'groupId': 'OG001', 'lowerLimit': '4.769', 'upperLimit': '11.369'}]}]}, {'title': '10 mg/kg BID; n=11, 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.952', 'groupId': 'OG000', 'lowerLimit': '6.932', 'upperLimit': '24.200'}, {'value': '18.750', 'comment': 'The 95% CI is not available because the number of participants analyzed is 2.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 48', 'description': 'Plasma samples were assayed for RTV concentrations using a validated assay. The GSK Department of Clinical Pharmacology Modeling and Simulation conducted PK analysis of the plasma RTV concentration-time data using a model-independent approach. As a measure of total drug exposure, the area under the plasma-concentration-versus-time curve over the dosing interval at steady-state (AUC\\[0-τ\\]), where τ is the length of the dosing interval, was calculated by the linear up/log down trapezoidal method.', 'unitOfMeasure': 'hr*µg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population. Only those participants contributing data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Plasma RTV Cmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FPV/RTV BID: 4 Weeks to <6 Months', 'description': 'Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day \\[BID\\]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.'}, {'id': 'OG001', 'title': 'FPV/RTV BID: 6 Months to <2 Years', 'description': 'Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day \\[BID\\]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.'}], 'classes': [{'title': '7 mg/kg BID, n=2, 23', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.404', 'comment': 'The 95% CI is not available because the number of participants analyzed is 2.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '1.576', 'groupId': 'OG001', 'lowerLimit': '0.991', 'upperLimit': '2.506'}]}]}, {'title': '10 mg/kg BID, n=12, 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.388', 'groupId': 'OG000', 'lowerLimit': '1.364', 'upperLimit': '4.180'}, {'value': '3.823', 'comment': 'The 95% CI is not available because the number of participants analyzed is 2.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 48', 'description': 'The maximum concentration at steady state (Cmax) was measured.', 'unitOfMeasure': 'µg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population. Only those participants contributing data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Plasma RTV Cτ', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FPV/RTV BID: 4 Weeks to <6 Months', 'description': 'Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day \\[BID\\]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.'}, {'id': 'OG001', 'title': 'FPV/RTV BID: 6 Months to <2 Years', 'description': 'Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day \\[BID\\]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.'}], 'classes': [{'title': '7 mg/kg BID, n=4, 33', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0795', 'groupId': 'OG000', 'lowerLimit': '0.0316', 'upperLimit': '0.1996'}, {'value': '0.2468', 'groupId': 'OG001', 'lowerLimit': '0.1875', 'upperLimit': '0.3249'}]}]}, {'title': '10 mg/kg BID, n=15, 19', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1855', 'groupId': 'OG000', 'lowerLimit': '0.1146', 'upperLimit': '0.3003'}, {'value': '0.4200', 'groupId': 'OG001', 'lowerLimit': '0.2958', 'upperLimit': '0.5962'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 48', 'description': 'The plasma concentration at the end of the dosing interval at steady state (Cτ) was measured.', 'unitOfMeasure': 'µg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population. Only those participants contributing data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Plasma RTV CL/F Expressed in mL/Min/kg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FPV/RTV BID: 4 Weeks to <6 Months', 'description': 'Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day \\[BID\\]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.'}, {'id': 'OG001', 'title': 'FPV/RTV BID: 6 Months to <2 Years', 'description': 'Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day \\[BID\\]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.'}], 'classes': [{'title': '7 mg/kg BID, n=2, 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '58.668', 'comment': 'The 95% CI is not available because the number of participants analyzed is 2.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '14.960', 'groupId': 'OG001', 'lowerLimit': '9.762', 'upperLimit': '22.927'}]}]}, {'title': '10 mg/kg BID, n=11, 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.118', 'groupId': 'OG000', 'lowerLimit': '6.435', 'upperLimit': '22.818'}, {'value': '8.938', 'comment': 'The 95% CI is not available because the number of participants analyzed is 2.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 48', 'description': 'Apparent clearance of drug from plasma following extravascular administration (CL/F) was calculated as dose in mg/kg units divided by AUC(0-τ). Normalizing CL/F for bodyweight allows for comparison of CL/F across populations.', 'unitOfMeasure': 'mL/min/kg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population. Only those participants contributing data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Plasma RTV CL/F Expressed in mL/Min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FPV/RTV BID: 4 Weeks to <6 Months', 'description': 'Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day \\[BID\\]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.'}, {'id': 'OG001', 'title': 'FPV/RTV BID: 6 Months to <2 Years', 'description': 'Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day \\[BID\\]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.'}], 'classes': [{'title': '7 mg/kg BID, n=2, 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '335.2', 'comment': 'The 95% CI is not available because the number of participants analyzed is 2.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '134.1', 'groupId': 'OG001', 'lowerLimit': '87.3', 'upperLimit': '205.8'}]}]}, {'title': '10 mg/kg BID, n=11, 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72.1', 'groupId': 'OG000', 'lowerLimit': '38.7', 'upperLimit': '134.3'}, {'value': '57.9', 'comment': 'The 95% CI is not available because the number of participants analyzed is 2.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 48', 'description': 'Apparent clearance of drug from plasma following extravascular administration (CL/F) was calculated as dose in mg/kg units divided by AUC(0-τ).', 'unitOfMeasure': 'mL/min', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population. Only those participants contributing data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ART-naïve FPV/RTV Treatment Group', 'description': 'ART-naïve Human immunodeficiency virus (HIV)-1-infected pediatric participants (received no antiretroviral agents prior to study enrollment) were enrolled in one of two cohorts based on their age: 6 months to \\<2 years (Cohort 1); 4 weeks to \\<6 months (Cohort 2). Participants initially underwent single dose visits (SDV). Cohort 1: SDV 1: 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, followed by SDV 2: 30/6 mg/kg FPV/ritonavir (RTV) oral solution. Cohort 2: SDV 1: 45/7 mg/kg FPV/RTV. The chronic dosing regimen for Cohort 1 was 45/7 mg/kg twice a day (BID) FPV/RTV, and for Cohort 2 was 30/7 mg/kg BID to 60/10 mg/kg BID. Per the preliminary data at Week 2 in Cohort 1, additional enrolled participants received 60/7 mg/kg FPV/RTV BID; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID with no dose increase at Week 2. In Cohort 2, additional enrolled participants received 45/10 mg/kg FPV/RTV BID.'}, {'id': 'OG001', 'title': 'PI-naïve, ART-experienced FPV/RTV Treatment Group', 'description': "PI-naïve, ART experienced, HIV-1-infected pediatric participants (received ART previously, but received \\<1 week's treatment with a PI) were enrolled in one of two cohorts based on their age: 6 months to \\<2 years (Cohort 1); 4 weeks to \\<6 months (Cohort 2). Participants initially underwent single dose visits (SDV). Cohort 1: SDV 1: 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, followed by SDV 2: 30/6 mg/kg FPV/ritonavir (RTV) oral solution. Cohort 2: SDV 1: 45/7 mg/kg FPV/RTV. The chronic dosing regimen for Cohort 1 was 45/7 mg/kg twice a day (BID) FPV/RTV, and for Cohort 2 was 30/7 mg/kg BID to 60/10 mg/kg BID. Per the preliminary data at Week 2 in Cohort 1, additional enrolled participants received 60/7 mg/kg FPV/RTV BID; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID with no dose increase at Week 2. In Cohort 2, additional enrolled participants received 45/10 mg/kg FPV/RTV BID."}, {'id': 'OG002', 'title': 'PI-experienced, ART-experienced FPV/RTV Treatment Group', 'description': 'PI- experienced, ART-experienced, HIV-1-infected pediatric participants (received ART previously, and \\>1 week prior PI therapy \\[no more than 3 PIs before study enrollment\\]) were enrolled in one of two cohorts based on their age: 6 months to \\<2 years (Cohort 1); 4 weeks to \\<6 months (Cohort 2). Participants initially underwent SDVs. Cohort 1: SDV 1: 30 mg/kg fosamprenavir (FPV) oral suspension, followed by SDV 2: 30/6 mg/kg FPV/ritonavir (RTV) oral solution. Cohort 2: SDV 1: 45/7 mg/kg FPV/RTV. The chronic dosing regimen for Cohort 1 was 45/7 mg/kg twice a day (BID) FPV/RTV, and for Cohort 2 was 30/7 mg/kg BID to 60/10 mg/kg BID. Per the preliminary data at Week 2 in Cohort 1, additional enrolled participants received 60/7 mg/kg FPV/RTV BID; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID with no dose increase at Week 2. In Cohort 2, additional enrolled participants received 45/10 mg/kg FPV/RTV BID.'}], 'classes': [{'title': 'Any HIV NRTI Mutation', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'HIV NRTI mutation M184V', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Any HIV NNRTI Mutation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'HIV NNRTI Mutation K101K/E', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Any HIV Major PI Mutations', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Any Minor HIV PI Mutations', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Minor HIV PI Mutation L10F', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Minor HIV PI Mutation L10I', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Minor HIV PI Mutation L33L/F', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Minor HIV PI Mutation L33F', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through Week 48', 'description': 'A blood sample was drawn for par. failing to respond to therapy, and the mutations present in the virus were identified. For each par., the mutations found at the time of failure were compared with any mutations found in the blood sample at baseline. New International AIDS Society-USA defined resistance mutations that developed at the time of failure were tabulated by drug class. VF, virologic failure; NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor. Par. are grouped by study arm and prior therapy experience.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'VF: par. with failure to achieve plasma HIV-RNA \\<400 copies/mL by Week 24; or confirmed HIV-RNA rebound to \\>=400 copies/mL any time after achieving plasma HIV-RNA \\<400 copies/mL and had evaluable viral isolate genotypic and/or phenotypic data. Only par. contributing viral genotype at both baseline and the indicated time of VF points were evaluable.'}, {'type': 'SECONDARY', 'title': 'Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ART-naïve FPV/RTV Treatment Group', 'description': 'ART-naïve Human immunodeficiency virus (HIV)-1-infected pediatric participants (received no antiretroviral agents prior to study enrollment) were enrolled in one of two cohorts based on their age: 6 months to \\<2 years (Cohort 1); 4 weeks to \\<6 months (Cohort 2). Participants initially underwent single dose visits (SDV). Cohort 1: SDV 1: 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, followed by SDV 2: 30/6 mg/kg FPV/ritonavir (RTV) oral solution. Cohort 2: SDV 1: 45/7 mg/kg FPV/RTV. The chronic dosing regimen for Cohort 1 was 45/7 mg/kg twice a day (BID) FPV/RTV, and for Cohort 2 was 30/7 mg/kg BID to 60/10 mg/kg BID. Per the preliminary data at Week 2 in Cohort 1, additional enrolled participants received 60/7 mg/kg FPV/RTV BID; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID with no dose increase at Week 2. In Cohort 2, additional enrolled participants received 45/10 mg/kg FPV/RTV BID.'}, {'id': 'OG001', 'title': 'ART-experienced, PI-naïve FPV/RTV Treatment Group', 'description': "PI-naïve, ART experienced, HIV-1-infected pediatric participants (received ART previously, but received \\<1 week's treatment with a PI) were enrolled in one of two cohorts based on their age: 6 months to \\<2 years (Cohort 1); 4 weeks to \\<6 months (Cohort 2). Participants initially underwent single dose visits (SDV). Cohort 1: SDV 1: 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, followed by SDV 2: 30/6 mg/kg FPV/ritonavir (RTV) oral solution. Cohort 2: SDV 1: 45/7 mg/kg FPV/RTV. The chronic dosing regimen for Cohort 1 was 45/7 mg/kg twice a day (BID) FPV/RTV, and for Cohort 2 was 30/7 mg/kg BID to 60/10 mg/kg BID. Per the preliminary data at Week 2 in Cohort 1, additional enrolled participants received 60/7 mg/kg FPV/RTV BID; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID with no dose increase at Week 2. In Cohort 2, additional enrolled participants received 45/10 mg/kg FPV/RTV BID."}, {'id': 'OG002', 'title': 'PI-experienced, ART-experienced FPV/RTV Treatment Group', 'description': 'PI- experienced, ART-experienced, HIV-1-infected pediatric participants (received ART previously, and \\>1 week prior PI therapy \\[no more than 3 PIs before study enrollment\\]) were enrolled in one of two cohorts based on their age: 6 months to \\<2 years (Cohort 1); 4 weeks to \\<6 months (Cohort 2). Participants initially underwent SDVs. Cohort 1: SDV 1: 30 mg/kg fosamprenavir (FPV) oral suspension, followed by SDV 2: 30/6 mg/kg FPV/ritonavir (RTV) oral solution. Cohort 2: SDV 1: 45/7 mg/kg FPV/RTV. The chronic dosing regimen for Cohort 1 was 45/7 mg/kg twice a day (BID) FPV/RTV, and for Cohort 2 was 30/7 mg/kg BID to 60/10 mg/kg BID. Per the preliminary data at Week 2 in Cohort 1, additional enrolled participants received 60/7 mg/kg FPV/RTV BID; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID with no dose increase at Week 2. In Cohort 2, additional enrolled participants received 45/10 mg/kg FPV/RTV BID.'}], 'classes': [{'title': 'Any NRTI', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Emtricitabine', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Lamivudine', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Any NNRTI', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Any PI', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Ritonavir-boosted Fosamprenavir', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through Week 48', 'description': 'A blood sample was drawn for par. failing to respond to therapy, and changes in DS for HIV isolated from the par. for each drug used in the study were assessed. The changes in DS detected by phenotypic assay in virus from the sample collected at the time of failure was compared with DS in the virus from the blood sample at baseline. Par. are grouped by study arm and prior therapy experience. DS is the state of HIV being susceptible to the antiretroviral agent (the virus can be inhibited by the drug). Reduced DS (i.e., HIV is resistant to the antiretroviral agent) can lead to treatment failure.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'VF: par. with failure to achieve plasma HIV-RNA \\<400 copies/mL by Week 24; or confirmed HIV-RNA rebound to \\>=400 copies/mL any time after achieving plasma HIV-RNA \\<400 copies/mL and had evaluable viral isolate genotypic and/or phenotypic data. Only par. contributing viral phenotype at both baseline and the indicated time of VF points were evaluable'}, {'type': 'SECONDARY', 'title': 'Number of Participants Reporting Perfect Adherence at Weeks 2, 12, 24, and 48 as Assessed by the Study Coordinator Using the Adherence Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2, Arm A - 4 Weeks to <6 Months', 'description': 'Participants with HIV-1 in Cohort 2 were initially administered with single dose administration of FPV/RTV 45/7 mg/kg (SDV1). The FPV/RTV dosage regimen selected for chronic dosing ranged from 30/7 mg/kg BID to 60/10 mg/kg BID. Subsequently enrolled participants were administered with FPV/RTV 45/10 mg/kg BID.'}, {'id': 'OG001', 'title': 'Cohort 1, Arm A - 6 Months to <2 Years', 'description': 'Participants with Human immunodeficiency virus (HIV-1) in Cohort 1 were initially administered single dose of fosamprenavir (FPV) 30 milligrams per kilogram (mg/kg) at single dose visit 1 (SDV1) or single dose of FPV/RTV 30/6 mg/kg (SDV2). Participants who underwent SDV2 administration began individualized regimens ranging from FPV 30 to 45/RTV 6 to 7 mg/kg twice a day (BID). Subsequently enrolled participants were administered with FPV/RTV 45/7 mg/kg BID.'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 2, 12, 24, and 48', 'description': "A separate questionnaire was administered for FPV and RTV. Items 1-4 of the Adherence Questionnaire measured a participant's adherence with FPV or RTV during the last 3 days and the weekend prior to the indicated study visits. Perfect adherence was defined as not missing any doses of FPV or RTV since the last study visit.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population. Only those participants contributing data at the indicated time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2, Arm A - 4 Weeks to <6 Months', 'description': 'Participants with HIV-1 in Cohort 2 were initially administered with single dose administration of FPV/RTV 45/7 mg/kg (SDV1). The FPV/RTV dosage regimen selected for chronic dosing ranged from 30/7 mg/kg BID to 60/10 mg/kg BID. Subsequently enrolled participants were administered with FPV/RTV 45/10 mg/kg BID.'}, {'id': 'OG001', 'title': 'Cohort 1, Arm A - 6 Months to <2 Years', 'description': 'Participants with Human immunodeficiency virus (HIV-1) in Cohort 1 were initially administered single dose of fosamprenavir (FPV) 30 milligrams per kilogram (mg/kg) at single dose visit 1 (SDV1) or single dose of FPV/RTV 30/6 mg/kg (SDV2). Participants who underwent SDV2 administration began individualized regimens ranging from FPV 30 to 45/RTV 6 to 7 mg/kg twice a day (BID). Subsequently enrolled participants were administered with FPV/RTV 45/7 mg/kg BID.'}], 'classes': [{'title': 'Week 2, color, dislike, n=23;27', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Week 2, color, neutral, n=23;27', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Week 2, color, like, n=23;27', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Week 24, color, dislike, n=20;24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Week 24, color, neutral, n=20;24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Week 24, color, like, n=20;24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Week 48, color, dislike, n=15;22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Week 48, color, neutral, n=15;22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Week 48, color, like, n=15;22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Week 2, texture, dislike, n=23;27', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Week 2, texture, neutral, n=23;27', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Week 2, texture, like, n=23;27', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Week 24, texture, dislike, n=20;24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Week 24, texture, neutral, n=20;24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Week 24, texture, like, n=20;24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Week 48, texture, dislike, n=15;21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Week 48, texture, neutral, n=15;21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Week 48, texture, like, n=15;21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Week 2, odor, dislike, n=23;27', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Week 2, odor, neutral, n=23;27', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Week 2, odor, like, n=23;27', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Week 24, odor, dislike, n=20;24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Week 24, odor, neutral, n=20;24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Week 24, odor, like, n=20;24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Week 48, odor, dislike, n=15;22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Week 48, odor, neutral, n=15;22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Week 48, odor, like, n=15;22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Week 2, general satisfaction, dislike, n=23;27', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Week 2, general satisfaction, neutral, n=23;27', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Week 2, general satisfaction, like, n=23;27', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Week 24, general satisfaction, dislike, n=20;24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Week 24, general satisfaction, neutral, n=20;24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Week 24, general satisfaction, like, n=20;24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Week 48, general satisfaction, dislike, n=15;22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Week 48, general satisfaction, neutral, n=15;22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Week 48, general satisfaction, like, n=15;22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 2, 24, and 48/premature study discontinuation', 'description': "P/G perceptions of FPV/RTV BID were assessed using a P/G Perception of Study Medication questionnaire administered during Weeks 2, 24, and 48/premature study discontinuation. Questions 1 to 4 ask directly about the P/G's assessment of 1=color, 2=texture/consistency, 3=odor, and 4=general satisfaction. Questions 5 to 10 ask about the P/G's perception of the child's assessment of the oral suspension. Data are reported as the number of participants with the indicated response by question, response category (1-3=dislike, 4=neutral, 5-7=like), and timing of visit.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': "Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10", 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 2, Arm A - 4 Weeks to <6 Months', 'description': 'Participants with HIV-1 in Cohort 2 were initially administered with single dose administration of FPV/RTV 45/7 mg/kg (SDV1). The FPV/RTV dosage regimen selected for chronic dosing ranged from 30/7 mg/kg BID to 60/10 mg/kg BID. Subsequently enrolled participants were administered with FPV/RTV 45/10 mg/kg BID.'}, {'id': 'OG001', 'title': 'Cohort 1, Arm A - 6 Months to <2 Years', 'description': 'Participants with Human immunodeficiency virus (HIV-1) in Cohort 1 were initially administered single dose of fosamprenavir (FPV) 30 milligrams per kilogram (mg/kg) at single dose visit 1 (SDV1) or single dose of FPV/RTV 30/6 mg/kg (SDV2). Participants who underwent SDV2 administration began individualized regimens ranging from FPV 30 to 45/RTV 6 to 7 mg/kg twice a day (BID). Subsequently enrolled participants were administered with FPV/RTV 45/7 mg/kg BID.'}], 'classes': [{'title': 'W2, Item 5, takes all/most med. easily, n=23;27', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'W2, Item 5, problem taking a few med., n=23;27', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'W2, Item 5, problem taking most med., n=23;27', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'W2, Item 5, impossible to take med., n=23;27', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'W24, Item 5, takes all/most med. easily, n=20;23', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'W24, Item 5, problem taking a few med., n=20;23', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'W24, Item 5, problem taking most med., n=20;23', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'W24, Item 5, impossible to take med., n=20;23', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'W48, Item 5, takes all/most med. easily, n=14;22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Week 48, Item 5, problem taking a few med., n=14;22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'W48, Item 5, problem taking most med., n=14;22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'W48, Item 5, impossible to take med., n=14;22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'W2, Item 6, dislike, n=23;27', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'W2, Item 6, neutral, n=23;27', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'W2, Item 6, like, n=23;27', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'W24, Item 6, dislike, n=20;23', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'W24, Item 6, neutral, n=20;23', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'W24, Item 6, like, n=20;23', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'W48, Item 6, dislike, n=15;22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'W48, Item 6, neutral, n=15;22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'W48, Item 6, like, n=15;22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'W2, Item 7, no problem taking FPV, n=23;27', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'W2, Item 7, few problems taking FPV, n=23;27', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'W2, Item 7, problem taking most of time, n=23;27', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'W2, Item 7, impossible to take, n=23;27', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'W24, Item 7, no problem taking FPV, n=20;23', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'W24, Item 7, few problems taking FPV, n=20;23', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'W24, Item 7, problem taking most of time, n=20;23', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'W24, Item 7, impossible to take, n=20;23', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'W48, Item 7, no problem taking FPV, n=15;22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'W48, Item 7, few problems taking FPV, n=15;22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'W48, Item 7, problem taking most of time, n=15;22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'W48, Item 7, impossible to take, n=15;22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'W2, Item 8, swallows with no problem, n=23;27', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'W2, Item 8, swallows with struggle, n=23;27', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'W2, Item 8, spits out suspension, n=23;27', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'W2, Item 8, vomits the suspension, n=23;27', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'W24, Item 8, swallows with no problem, n=20;23', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'W24, Item 8, swallows with struggle, n=20;23', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'W24, Item 8, spits out suspension, n=20;23', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'W24, Item 8, vomits the suspension, n=20;23', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'W48, Item 8, swallows with no problem, n=15;22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'W48, Item 8, swallows with struggle, n=15;22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'W48, Item 8, spits out suspension, n=15;22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'W48, Item 8, vomits the suspension, n=15;22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'W2, I9, take more willingly than other med., n=23;27', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'W2, Item 9, about the same, n=23;27', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'W2, I9, not as willing to take as other med., n=23;27', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'W24, I9, take more willingly than other med., n=20;22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'W24, Item 9, about the same, n=20;22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'W24, I9, not as willing to take as other med, n=20;22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'W48, I9, take more willingly than other med., n=15;22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'W48, Item 9, about the same, n=15;22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'W48, I9, not as willing to take as other med, n=15;22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Week 2, Item 10, dislike, n=23;27', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Week 2, Item 10, neutral, n=23;27', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Week 2, Item 10, like, n=23;27', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Week 24, Item 10, dislike, n=20;24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Week 24, Item 10, neutral, n=20;24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Week 24, Item 10, like, n=20;24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Week 48, Item 10, dislike, n=15;22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Week 48, Item 10, neutral, n=15;22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Week 48, Item 10, like, n=15;22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks (W) 2, 24, and 48/premature study discontinuation', 'description': "Parent/guardian perceptions of FPV/RTV BID was assessed using a Parent/Guardian Perception of Study Medication questionnaire. Questions 1 to 4 ask directly about the parent/guardian's assessment of the color, texture/consistency, odor, and general satisfaction. Questions 5 to 10 ask about the parent/guardian's perception of the child's assessment of the oral suspension (Items: 5=reaction to new medicine \\[med.\\]; 6=taste; 7=acceptance; 8=swallowing; 9=willingness compared to other med.; 10=overall liking. Data for items 6/10 are reported in response categories: 1-3=dislike; 4=neutral; 5-7=like.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'Correlation Between Steady-state Plasma APV PK Parameters to Changes in Plasma HIV-1 RNA Concentrations, CD4+ Percentages, and/or the Occurrence of Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FPV/RTV BID: 4 Weeks to <6 Months', 'description': 'Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day \\[BID\\]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.'}, {'id': 'OG001', 'title': 'FPV/RTV BID: 6 Months to <2 Years', 'description': 'Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day \\[BID\\]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.'}], 'timeFrame': 'Week 48', 'description': 'No formal analysis has been performed or is planned to correlate plasma APV PK with efficacy and safety outcomes.', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population'}, {'type': 'SECONDARY', 'title': 'Plasma FPV AUC (0-τ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FPV/RTV BID: 4 Weeks to <6 Months', 'description': 'Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day \\[BID\\]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.'}, {'id': 'OG001', 'title': 'FPV/RTV BID: 6 Months to <2 Years', 'description': 'Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day \\[BID\\]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.'}], 'timeFrame': 'Week 48', 'description': 'The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population'}, {'type': 'SECONDARY', 'title': 'Plasma FPV Cmax and Cτ', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FPV/RTV BID: 4 Weeks to <6 Months', 'description': 'Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day \\[BID\\]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.'}, {'id': 'OG001', 'title': 'FPV/RTV BID: 6 Months to <2 Years', 'description': 'Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day \\[BID\\]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.'}], 'timeFrame': 'Week 48', 'description': 'The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population'}, {'type': 'SECONDARY', 'title': 'Plasma FPV CL/F Expressed in mL/Min/kg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FPV/RTV BID: 4 Weeks to <6 Months', 'description': 'Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day \\[BID\\]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.'}, {'id': 'OG001', 'title': 'FPV/RTV BID: 6 Months to <2 Years', 'description': 'Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day \\[BID\\]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.'}], 'timeFrame': 'Week 48', 'description': 'The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population'}, {'type': 'SECONDARY', 'title': 'Plasma FPV CL/F Expressed in mL/Min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'FPV/RTV BID: 4 Weeks to <6 Months', 'description': 'Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day \\[BID\\]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.'}, {'id': 'OG001', 'title': 'FPV/RTV BID: 6 Months to <2 Years', 'description': 'Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day \\[BID\\]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.'}], 'timeFrame': 'Week 48', 'description': 'The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort 1, Arm A - 6 Months to <2 Years', 'description': 'Participants with Human immunodeficiency virus (HIV-1) in Cohort 1 were initially administered single dose of fosamprenavir (FPV) 30 milligrams per kilogram (mg/kg) at single dose visit 1 (SDV1) or single dose of FPV/RTV 30/6 mg/kg (SDV2). Participants who underwent SDV2 administration began individualized regimens ranging from FPV 30 to 45/RTV 6 to 7 mg/kg twice a day (BID). Subsequently enrolled participants were administered with FPV/RTV 45/7 mg/kg BID.'}, {'id': 'FG001', 'title': 'Cohort 2, Arm A - 4 Weeks to <6 Months', 'description': 'Participants with HIV-1 in Cohort 2 were initially administered with single dose administration of FPV/RTV 45/7 mg/kg (SDV1). The FPV/RTV dosage regimen selected for chronic dosing ranged from 30/7 mg/kg BID to 60/10 mg/kg BID. Subsequently enrolled participants were administered with FPV/RTV 45/10 mg/kg BID.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Insufficient Viral Load Response', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lack of availability of RTV', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Relocation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The study was conducted between 23-Oct-2003 to 29-March-2022 in Argentina, Mexico, Portugal and South Africa. The cut off date for 48 week primary endpoint was July 5th 2011.', 'preAssignmentDetails': '59 participants were enrolled in the study and received at least one dose of Fosamprenavir (FPV)/Ritonavir (RTV) (Safety Population). Five participants out of 59 only received single dose before discontinuing the study. 54 participants who received both single and multiple doses of FPV/RTV were included in Intent to Treat-Exposed (ITT-E) population.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort 1, Arm A - 6 Months to <2 Years', 'description': 'Participants with Human immunodeficiency virus (HIV-1) in Cohort 1 were initially administered single dose of fosamprenavir (FPV) 30 milligrams per kilogram (mg/kg) at single dose visit 1 (SDV1) or single dose of FPV/RTV 30/6 mg/kg (SDV2). Participants who underwent SDV2 administration began individualized regimens ranging from FPV 30 to 45/RTV 6 to 7 mg/kg twice a day (BID). Subsequently enrolled participants were administered with FPV/RTV 45/7 mg/kg BID.'}, {'id': 'BG001', 'title': 'Cohort 2, Arm A - 4 Weeks to <6 Months', 'description': 'Participants with HIV-1 in Cohort 2 were initially administered with single dose administration of FPV/RTV 45/7 mg/kg (SDV1). The FPV/RTV dosage regimen selected for chronic dosing ranged from 30/7 mg/kg BID to 60/10 mg/kg BID. Subsequently enrolled participants were administered with FPV/RTV 45/10 mg/kg BID.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '13.3', 'spread': '5.6', 'groupId': 'BG000'}, {'value': '3.4', 'spread': '0.95', 'groupId': 'BG001'}, {'value': '8.6', 'spread': '6.43', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Participants who received both single and multiple doses of FPV/RTV were included in Intent to Treat-Exposed (ITT-E) population.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-11-20', 'size': 2043306, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-03-27T14:39', 'hasProtocol': True}, {'date': '2022-03-21', 'size': 1436318, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-03-27T14:39', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-10-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2022-03-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-09', 'studyFirstSubmitDate': '2003-10-30', 'resultsFirstSubmitDate': '2012-03-02', 'studyFirstSubmitQcDate': '2003-10-30', 'lastUpdatePostDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2012-07-19', 'studyFirstPostDateStruct': {'date': '2003-10-31', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-08-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Participants With Treatment Emergent Adverse Events (AEs)', 'timeFrame': 'Day 1 and up to week 684', 'description': 'An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (that could include a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.'}, {'measure': 'Number of Participants With Clinical Chemistry Toxicities', 'timeFrame': 'Day 1 and up to Week 684', 'description': 'Blood samples were collected for the analysis of all clinical chemistry parameters. Laboratory toxicities were graded using the Division of AIDS (DAIDS) table for grading the severity of adult and pediatric adverse events, where grade 1=mild, grade 2=moderate, grade 3=severe and grade 4=potentially life-threatening. Results for participants with Grade 1 to 4 clinical chemistry toxicities is presented.'}, {'measure': 'Number of Participants With Hematology Toxicities', 'timeFrame': 'Day 1 and up to Week 684', 'description': 'Blood samples were collected for the analysis of all hematology parameters. Laboratory toxicities were graded using the DAIDS Table for grading the severity of adult and pediatric adverse events, where grade 1=mild, grade 2=moderate, grade 3=severe and grade 4=potentially life-threatening. Results for participants with Grade 1 to 4 hematology toxicities is presented.'}, {'measure': 'Number of Participants With Treatment Limiting Toxicities', 'timeFrame': 'Day 1 and up to Week 684', 'description': 'Treatment limiting toxicities are defined as those that are related to investigational medicinal products and deemed to be unacceptable, leading to restriction of further dose escalation.'}, {'measure': 'Number of Participants Who Permanently Discontinued the Treatment Due to Adverse Event', 'timeFrame': 'Day 1 and up to Week 684', 'description': 'An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (that could include a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.'}], 'primaryOutcomes': [{'measure': 'Plasma Amprenavir (APV) AUC (0-tau[τ])', 'timeFrame': 'Week 48', 'description': 'Plasma samples were assayed for APV concentrations using a validated assay. The GlaxoSmithKline (GSK) Department of Clinical Pharmacology Modeling and Simulation conducted pharmacokinetic (PK) analysis of the plasma APV concentration-time data using a model-independent approach. As a measure of total drug exposure, the area under the plasma-concentration-versus-time curve over the dosing interval at steady-state (AUC\\[0-τ\\]), where "τ" is the length of the dosing interval, was calculated by the linear up/log down trapezoidal method. hours, hr.'}, {'measure': 'Plasma APV Cmax', 'timeFrame': 'Week 48', 'description': 'The maximum concentration at steady state (Cmax) was measured.'}, {'measure': 'Plasma APV Cτ', 'timeFrame': 'Week 48', 'description': 'The plasma concentration at the end of the dosing interval at steady state (Cτ) was measured.'}, {'measure': 'Plasma APV CL/F Following Dosing Expressed in mL/Min/kg', 'timeFrame': 'Week 48', 'description': 'Apparent clearance of drug from plasma following extravascular administration (CL/F) was calculated using the formulation: APV Dose in mg/kg units divided by AUC(0-τ). For FPV, doses were expressed in APV molar equivalents (50 mg of FPV = 43.2 mg of APV). Normalizing CL/F for bodyweight allows for comparison of CL/F across populations.'}, {'measure': 'Plasma APV CL/F Following Dosing Expressed in mL/Min', 'timeFrame': 'Week 48', 'description': 'Apparent clearance of drug from plasma following extravascular administration (CL/F) was calculated as dose/AUC(0-τ). For FPV, doses were expressed in APV molar equivalents (50 mg of FPV = 43.2 mg of APV).'}, {'measure': 'Plasma Unbound APV Cτ', 'timeFrame': 'Week 48', 'description': 'Participants who are \\<2 years old may have reduced protein binding; therefore, plasma unbound APV concentrations were measured to determine dosing recommendations at acceptable dosing volumes. Unbound or "free" APV is the fraction of drug that is not bound to protein. Cτ is the plasma concentration at the end of the dosing interval at steady state.'}, {'measure': 'Plasma Unbound APV Percent Protein Binding (%Cτ)', 'timeFrame': 'Week 48', 'description': 'Participants who are \\<2 years old may have reduced protein binding; therefore, plasma unbound APV concentrations were measured to determine dosing recommendations at acceptable dosing volumes. APV %Cτ unbound is the percentage of the total APV Cτ that is unbound.'}, {'measure': 'Absolute Values of Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48', 'timeFrame': 'Baseline (Day 1) and Weeks 4, 12, 24, 36, and 48', 'description': 'Blood samples of the participants were collected for the evaluation of ALT and AST. Clinical chemistry analyses were carried out using the observed analysis strategy.'}, {'measure': 'Absolute Values of Cholesterol, Glucose, High Density Lipoprotein (HDL) Cholesterol, Low Density Lipoprotein (LDL) and Triglyceride (TG) at Baseline (Day 1), Weeks 4, 12, 24, 36, and 48', 'timeFrame': 'Baseline (Day 1) and Weeks 4, 12, 24, 36, and 48', 'description': 'Blood samples of all participants were generally collected under non-fasting conditions (given the age of participants) for the evaluation of cholesterol, serum glucose, HDL cholesterol, LDL cholesterol and triglyceride (TG). Clinical chemistry analyses were carried out using the observed analysis strategy.'}, {'measure': 'Absolute Values of Serum Lipase at Baseline (Day 1), Weeks 4, 12, 24, and 48', 'timeFrame': 'Baseline (Day 1) and Weeks 4, 12, 24, and 48', 'description': 'Blood samples of all participants were collected for the evaluation of serum lipase. Clinical chemistry analyses were carried out using the observed analysis strategy. Change from Baseline in serum lipase was calculated as the value at the indicated time point minus the value at Baseline.'}, {'measure': 'Number of Participants With the Indicated Treatment-emergent (TE) Grade 3/4 Laboratory Abnormalities', 'timeFrame': 'Baseline (Day 1) until Week 48', 'description': 'TE toxicities were presented for each laboratory parameter. A toxicity was considered TE if it was greater than the Baseline grade, and if it was observed on/after the date of the first dose of study drug (SD), and on/before the date of the last dose of SD. Per the Division of AIDS Table for Grading the Severity of Adult and Pediatric AEs, Grade 3=severe; Grade 4=potentially life-threatening.'}, {'measure': 'Number of Participants With the Indicated Treatment-emergent (TE) Grade 3/4 Adverse Events (AE)', 'timeFrame': 'Baseline (Day 1) until Week 48', 'description': 'An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE is considered TE if it has an onset date on or after the date of the first dose of study drug, and on or before the date of the final dose of study drug. As per the Division of AIDS Table for Grading the Severity of Adult and Pediatric AEs, Grade 3=severe; Grade 4=potentially life-threatening.'}, {'measure': 'Number of Participants Who Permanently Discontinued the Treatment Due to an AE', 'timeFrame': 'Baseline (Day 1) until Week 48', 'description': 'An AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Plasma Human Immuno Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Levels < 400 Copies/Milliliter at Each Study Visit', 'timeFrame': 'Baseline (Day 1) and up to Week 684', 'description': 'Blood samples of participants were collected to measure plasma HIV-1 RNA concentrations.'}, {'measure': 'Change From Baseline in Plasma HIV-1 RNA Levels at Each Study Visit', 'timeFrame': 'Baseline (Day 1) and up to Week 684', 'description': 'Blood samples of participants were collected to measure plasma HIV-1 RNA copies. Baseline value was defined as the value observed at the day 1 visit or if this value is missing the last value observed before the start of investigational product. Change from baseline value was defined as post-dose value minus baseline value.'}, {'measure': 'Absolute Values of Cluster of Differentiation 4 (CD4+) Cell Counts by Study Visit', 'timeFrame': 'Baseline (Day 1) and up to week 684', 'description': 'Blood samples of participants were collected for the measurement of the CD4+ cells.'}, {'measure': 'Plasma FPV Concentrations', 'timeFrame': 'Post -Week 48 through Week 684'}, {'measure': 'Number of Participants With Treatment-Emergent Mutations at Virologic Failure Timepoint', 'timeFrame': 'Week 48 to Week 684', 'description': 'A blood sample was drawn from participants failing to respond to therapy, and genotyping was performed to identify the mutations present in the baseline (pre-therapy) and the sample obtained at virologic failure (VF). For each participant, the HIV-1 mutations found at the time of failure were compared with any HIV-1 mutations detected in the blood sample at baseline. New International AIDS Society-USA defined resistance mutations that developed at the time of failure were tabulated by drug class- NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor. Participants are grouped by study arm (prior therapy experience), results displayed in this table are from participants who met virologic failure criteria from Week 48 through Week 684.'}, {'measure': 'Number of Participants With Treatment-Emergent Changes in HIV-1 Phenotypic Drug Susceptibility', 'timeFrame': 'Post-Week 48 to Week 684', 'description': 'A blood sample was drawn from participant failing to respond to therapy, and the mutations present in the virus were identified. Phenotypic resistance was assessed for virologic failure population and evaluated for Protease Inhibitors (PIs), Nucleotide reverse transcriptase inhibitors (NRTIs), and non-NRTIs (NNTRIs) using Monogram PhenoSense Assay. Virologic failure was defined as having failed to achieve a plasma HIV-RNA of \\<400 copies/mL by Week 24 or having had a confirmed HIV-RNA rebound to ≥400 c/mL at any time after achieving a plasma HIV-RNA of \\<400 c/mL.'}, {'measure': 'Number of Participants With Plasma HIV-1 Ribonucleic Acid (RNA) <400 Copies Per Milliliter at Baseline and Weeks 4, 12, 24, 36, and 48 (MSD=F)', 'timeFrame': 'Baseline and Weeks 4, 12, 24, 36, and 48', 'description': 'Blood samples of participants were collected to measure plasma HIV-1 RNA concentrations. Viral load, measured in RNA copies per milliliter of plasma, is an efficacy measure for antiretroviral drugs. In the Missing, Switch, or Discontinuation=Failure (MSD=F) analysis, participants who had missing data at or had discontinued the study prior to a certain time point or had changed their background antiretroviral regimen are classified as non-responders.'}, {'measure': 'Median Plasma HIV-1 RNA (log10 Copies/mL) at Baseline and Weeks 4, 12, 24, 36, and 48 (Observed Analysis)', 'timeFrame': 'Baseline and Weeks 4, 12, 24, 36, and 48', 'description': 'Blood samples of participants were collected to assess the decrease in the number of HIV-1 RNA copies.'}, {'measure': 'Median Change From Baseline in Plasma HIV-1 RNA (log10 Copies/mL) at Weeks 4, 12, 24, 36, and 48 (Observed Analysis)', 'timeFrame': 'Baseline and Weeks 4, 12, 24, 36, and 48', 'description': 'Blood samples of participants were collected to assess the decrease in the number of HIV-1 RNA copies. Change from Baseline in plasma HIV-1 RNA was calculated as the value at the indicated time point minus the value at Baseline.'}, {'measure': 'Number of Participants With at Least a 1.0 log10 HIV-1 RNA Decrease From Baseline at Weeks 4, 12, 24, 36, and 48 (MSD=F Analysis)', 'timeFrame': 'Baseline and Weeks 4, 12, 24, 36, and 48', 'description': 'Blood samples of participants were collected to assess the decrease in the number of HIV-1 RNA copies. In the MSD=F analysis, participants who had missing data at or had discontinued the study prior to a certain time point or had changed their background antiretroviral regimen are classified as non-responders.'}, {'measure': 'Median Percent Cluster of Differentiation Antigen 4 (CD4+) Cell Count at Baseline and at Weeks 4, 12, 24, 36, and 48', 'timeFrame': 'Baseline and Weeks 4, 12, 24, 36, and 48', 'description': 'Blood samples of participants were collected for the measurement of the percentage of total lymphocytes that are CD4+ cells. Observed analysis was used for the summary of proportion endpoints using viral load data. CD4+ cells are white blood cells that are important in fighting infection. HIV infects CD4+ cells, replicates in them, and destroys them. A CD4+ cell count provides a measure of the status of the immune system and to what extent it is affected by HIV.'}, {'measure': 'Median Percent Change From Baseline in CD4+ Cell Count at Weeks 4, 12, 24, 36, and 48', 'timeFrame': 'Baseline and Weeks 4, 12, 24, 36, and 48', 'description': 'Blood samples of participants were collected for the measurement of the percentage of total lymphocytes that are CD4+ cells. Observed analysis was used for the summary of proportion endpoints using viral load data. Change from Baseline in percentage was calculated as the value at indicated time points minus the value at Baseline.'}, {'measure': 'Number of Participants With the Indicated Virological Outcome at Week 48', 'timeFrame': 'Week 48', 'description': 'Blood samples of participants were collected to measure plasma HIV-1 RNA concentrations. PI-exp = PI-experienced. Virologic success was defined as plasma HIV-1 RNA \\<400 copies/mL. Virologic failure: (1) HIV-1 RNA \\>=400 copies/mL, (2) change of background antiretroviral treatment (ART), (3) discontinued study due to lack of efficacy, (4) discontinued study with last HIV-1 \\>=400 copies/mL. No virologic data at Week 48 window: (a) discontinued study due to an adverse event or death, (b) discontinued study due to other reasons (withdrew consent, loss to follow-up, moved, etc.).'}, {'measure': 'Plasma Ritonavir (RTV) AUC (0-τ)', 'timeFrame': 'Week 48', 'description': 'Plasma samples were assayed for RTV concentrations using a validated assay. The GSK Department of Clinical Pharmacology Modeling and Simulation conducted PK analysis of the plasma RTV concentration-time data using a model-independent approach. As a measure of total drug exposure, the area under the plasma-concentration-versus-time curve over the dosing interval at steady-state (AUC\\[0-τ\\]), where τ is the length of the dosing interval, was calculated by the linear up/log down trapezoidal method.'}, {'measure': 'Plasma RTV Cmax', 'timeFrame': 'Week 48', 'description': 'The maximum concentration at steady state (Cmax) was measured.'}, {'measure': 'Plasma RTV Cτ', 'timeFrame': 'Week 48', 'description': 'The plasma concentration at the end of the dosing interval at steady state (Cτ) was measured.'}, {'measure': 'Plasma RTV CL/F Expressed in mL/Min/kg', 'timeFrame': 'Week 48', 'description': 'Apparent clearance of drug from plasma following extravascular administration (CL/F) was calculated as dose in mg/kg units divided by AUC(0-τ). Normalizing CL/F for bodyweight allows for comparison of CL/F across populations.'}, {'measure': 'Plasma RTV CL/F Expressed in mL/Min', 'timeFrame': 'Week 48', 'description': 'Apparent clearance of drug from plasma following extravascular administration (CL/F) was calculated as dose in mg/kg units divided by AUC(0-τ).'}, {'measure': 'Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent HIV Genotypic Resistance in Reverse Transcriptase and Protease', 'timeFrame': 'Baseline through Week 48', 'description': 'A blood sample was drawn for par. failing to respond to therapy, and the mutations present in the virus were identified. For each par., the mutations found at the time of failure were compared with any mutations found in the blood sample at baseline. New International AIDS Society-USA defined resistance mutations that developed at the time of failure were tabulated by drug class. VF, virologic failure; NRTI, nucleoside reverse transcriptase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor. Par. are grouped by study arm and prior therapy experience.'}, {'measure': 'Number of Confirmed Virologic Failure Participants (Par.) With Treatment-emergent Reductions in Drug Susceptibility (DS)', 'timeFrame': 'Baseline through Week 48', 'description': 'A blood sample was drawn for par. failing to respond to therapy, and changes in DS for HIV isolated from the par. for each drug used in the study were assessed. The changes in DS detected by phenotypic assay in virus from the sample collected at the time of failure was compared with DS in the virus from the blood sample at baseline. Par. are grouped by study arm and prior therapy experience. DS is the state of HIV being susceptible to the antiretroviral agent (the virus can be inhibited by the drug). Reduced DS (i.e., HIV is resistant to the antiretroviral agent) can lead to treatment failure.'}, {'measure': 'Number of Participants Reporting Perfect Adherence at Weeks 2, 12, 24, and 48 as Assessed by the Study Coordinator Using the Adherence Questionnaire', 'timeFrame': 'Weeks 2, 12, 24, and 48', 'description': "A separate questionnaire was administered for FPV and RTV. Items 1-4 of the Adherence Questionnaire measured a participant's adherence with FPV or RTV during the last 3 days and the weekend prior to the indicated study visits. Perfect adherence was defined as not missing any doses of FPV or RTV since the last study visit."}, {'measure': 'Number of Participants With the Indicated Response Scores for the Parent/Guardian (P/G) Perception of FPV Oral Suspension Questionnaire: Items 1 to 4', 'timeFrame': 'Weeks 2, 24, and 48/premature study discontinuation', 'description': "P/G perceptions of FPV/RTV BID were assessed using a P/G Perception of Study Medication questionnaire administered during Weeks 2, 24, and 48/premature study discontinuation. Questions 1 to 4 ask directly about the P/G's assessment of 1=color, 2=texture/consistency, 3=odor, and 4=general satisfaction. Questions 5 to 10 ask about the P/G's perception of the child's assessment of the oral suspension. Data are reported as the number of participants with the indicated response by question, response category (1-3=dislike, 4=neutral, 5-7=like), and timing of visit."}, {'measure': "Number of Participants With the Indicated Response Scores for the Parent/Guardian Perception of the Child's Assessment of FPV Oral Suspension Questionnaire: Items (I) 5 to 10", 'timeFrame': 'Weeks (W) 2, 24, and 48/premature study discontinuation', 'description': "Parent/guardian perceptions of FPV/RTV BID was assessed using a Parent/Guardian Perception of Study Medication questionnaire. Questions 1 to 4 ask directly about the parent/guardian's assessment of the color, texture/consistency, odor, and general satisfaction. Questions 5 to 10 ask about the parent/guardian's perception of the child's assessment of the oral suspension (Items: 5=reaction to new medicine \\[med.\\]; 6=taste; 7=acceptance; 8=swallowing; 9=willingness compared to other med.; 10=overall liking. Data for items 6/10 are reported in response categories: 1-3=dislike; 4=neutral; 5-7=like."}, {'measure': 'Correlation Between Steady-state Plasma APV PK Parameters to Changes in Plasma HIV-1 RNA Concentrations, CD4+ Percentages, and/or the Occurrence of Adverse Events', 'timeFrame': 'Week 48', 'description': 'No formal analysis has been performed or is planned to correlate plasma APV PK with efficacy and safety outcomes.'}, {'measure': 'Plasma FPV AUC (0-τ)', 'timeFrame': 'Week 48', 'description': 'The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.'}, {'measure': 'Plasma FPV Cmax and Cτ', 'timeFrame': 'Week 48', 'description': 'The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.'}, {'measure': 'Plasma FPV CL/F Expressed in mL/Min/kg', 'timeFrame': 'Week 48', 'description': 'The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.'}, {'measure': 'Plasma FPV CL/F Expressed in mL/Min', 'timeFrame': 'Week 48', 'description': 'The majority of the FPV data were below the quantification limit. Therefore, plasma FPV PK parameters were not estimated.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['pediatrics', 'ritonavir', 'amprenavir', 'AGENERASE', 'HIV', 'Lexiva', 'protease inhibitors', 'HIV Infection', 'fosamprenavir'], 'conditions': ['Infection, Human Immunodeficiency Virus', 'HIV Infections']}, 'referencesModule': {'references': [{'pmid': '23811743', 'type': 'BACKGROUND', 'citation': 'Cotton M, Cassim H, Pavia-Ruz N, Garges HP, Perger T, Ford SL, Wire MB, Givens N, Ross LL, Lou Y, Sievers J, Cheng K. Pharmacokinetics, safety and antiviral activity of fosamprenavir/ritonavir-containing regimens in HIV-infected children aged 4 weeks to 2 years-48-week study data. Pediatr Infect Dis J. 2014 Jan;33(1):57-62. doi: 10.1097/INF.0b013e3182a1123a.'}]}, 'descriptionModule': {'briefSummary': 'This is a 48-week study to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of an investigational regimen including FDA approved HIV drugs in HIV-infected pediatric subjects, ages 4 weeks to \\< 2 years old.', 'detailedDescription': 'A 48 week, Phase II, open-label, 2-cohort, multicenter study to evaluate the pharmacokinetics, safety, tolerability and antiviral activity of GW433908 and GW433908/RTV when administered to HIV-1 infected protease inhibitor (PI) naive and PI-experienced pediatric subjects aged 4 weeks to \\<2 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '2 Years', 'minimumAge': '4 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female 4 weeks to \\<2 years of age. Cohort 1 (6 months - \\<2 years): Subjects must be \\<2 years of age at the Week 2 visit therefore the maximum age at screening is 22 months.\n\nCohort 2 (4 weeks - \\<6 months): Subjects must be \\<6 months of age at the Week 2 visit, therefore the maximum age at screening is 4 months for entry into this cohort.\n\n* Parent or legal guardian is willing and able to provide written informed consent for the subject to participate in the trial.\n* Screening plasma HIV-1 RNA level \\>=400copies/mL.\n* Subjects who, in the investigator's opinion, and following viral resistance testing if conducted, are able to construct an active Nucleoside Reverse Transcriptase Inhibitor (NRTI) backbone regimen consisting of 2 NRTIs.\n* Subjects must meet one of the following criteria:\n\nTherapy-naïve or PI-naïve subjects (defined as having received less than one week of any PI).\n\nPI-experienced subjects defined as having prior experience with no more than three PIs. Prior RTV-boosted PI therapy will be considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.\n\nExclusion Criteria:\n\n* Prior history of having received APV.\n* Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) therapy within 14 days prior to study drug administration (single or multiple dose) or anticipated need for concurrent NNRTI therapy during the study period.\n* PI therapy within 5 days prior to study drug administration (applicable only for subjects undergoing single dose visits)\n* Subjects and/or parents/legal guardians who, in the investigator's opinion, are not able to comply with the requirements of the study.\n* Subject is in the initial acute phase of a Centers for Disease Control and Prevention (CDC) Clinical Category C event or infection (per 1994 classification) at Baseline. Subject may be enrolled provided they are receiving treatment for the infections, such treatment not being contraindicated with FPV, and subjects are clinically improving at the Baseline visit.\n* Presence of a malabsorption syndrome or other gastrointestinal dysfunction which might interfere with drug absorption or render the subject unable to take oral medication.\n* Presence of any serious medical condition (e.g., hemoglobinopathy, chronic anemia, diabetes, cardiac dysfunction, hepatitis, or clinically relevant pancreatitis) which, in the opinion of the investigator, might compromise the safety of the subject.\n* Any acute laboratory abnormality at screen which, in the opinion of the investigator, should preclude the subject's participation in the study of an investigational compound. If subjects are found to have an acute Grade 4 laboratory abnormality at screening, this test may be repeated once within the screening window. Any verified Grade 4 laboratory abnormality would exclude a subject from study participation.\n* Grade 3 or higher (\\>10x ULN) serum aminotransferase levels (alanine aminotransferase, ALT and/or aspartate aminotransferase, AST) within 28 days prior to study drug administration and / or clinically relevant hepatitis within the previous 6 months.\n* Treatment with radiation therapy or cytotoxic chemotherapeutic agents within 28 days of study drug administration or an anticipated need for such treatment within the study period.\n* Treatment with immunomodulating agents (e.g., systemic corticosteroids, interleukins, interferons) or any agent with known anti-HIV activity (e.g., hydroxyurea or foscarnet) within 28 days of study drug administration.\n* Treatment with any of the following medications within 28 days prior to receiving study medication or the anticipated need during the study:\n\nAmiodarone, astemizole, bepridil, bupropion, cisapride, clorazepate, clozapine, diazepam, dihydroergotamine, encainide, ergonovine, ergotamine, estazolam, flecainide, flurazepam, lovastatin, meperidine, methylergonovine, midazolam, pimozide, piroxicam, propafenone, propoxyphene, quinidine, simvastatin, terfenadine, and triazolam (these drugs have been excluded for safety reasons).\n\nCarbamazepine, dexamethasone, phenobarbital, primidone, rifampin, St Johns Wort, (these drugs have been excluded because they have the potential to decrease plasma protease inhibitor concentrations).\n\n* Treatment with other investigational drugs/therapies within 28 days prior to receiving study medication (note: treatments available through a Treatment IND or other expanded-access mechanism will be evaluated on a case-by-case basis in consultation with the sponsor).\n* History of drug or other allergy which, in the opinion of the investigator, contraindicates participation in the trial or known hypersensitivity to any study medications (e.g. documented hypersensitivity to a nucleoside analogue)."}, 'identificationModule': {'nctId': 'NCT00071760', 'briefTitle': 'Study Of An Investigational Regimen Including FDA Approved HIV Drugs In HIV-Infected Pediatric Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'ViiV Healthcare'}, 'officialTitle': 'A 48 Week, Phase II, Open-label, 2-cohort, Multicenter Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Antiviral Activity of GW433908 and GW433908/RTV When Administered to HIV-1 Infected Protease Inhibitor (PI) Naive and PI-experienced Pediatric Subjects Aged 4 Weeks to <2 Years.', 'orgStudyIdInfo': {'id': 'APV20002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A - 4weeks - less than 2 years old (FPV/RTV bid)', 'description': 'Cohort 2A - 4weeks - less than 6 months old. Fosamprenavir (FPV) 50 mg/mL oral suspension/ritonavir (RTV) 80 mg/mL oral solution twice daily (BID)\n\nCohort 1A - 6 months - less than 2yrs old. Fosamprenavir (FPV) 50 mg/mL oral suspension/ritonavir (RTV) 80 mg/mL oral solution twice daily (BID)', 'interventionNames': ['Drug: GW433908', 'Drug: ritonavir']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B- 4weeks - less than 2 years old (FPV bid)', 'description': 'Cohort 2B - 4weeks - less than 6 months old. Fosamprenavir (FPV) 50 mg/mL oral suspension twice daily (BID)\n\nCohort 1B - 6 months - less than 2yrs old. Fosamprenavir (FPV) 50 mg/mL oral suspension twice daily (BID)', 'interventionNames': ['Drug: GW433908']}], 'interventions': [{'name': 'GW433908', 'type': 'DRUG', 'description': 'Fosamprenavir suspension bid', 'armGroupLabels': ['Arm A - 4weeks - less than 2 years old (FPV/RTV bid)', 'Arm B- 4weeks - less than 2 years old (FPV bid)']}, {'name': 'ritonavir', 'type': 'DRUG', 'otherNames': ['GW433908'], 'description': 'Ritonavir solution bid', 'armGroupLabels': ['Arm A - 4weeks - less than 2 years old (FPV/RTV bid)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32209', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '1405', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': '06720', 'city': 'Mexico City', 'country': 'Mexico', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'zip': '6720', 'city': 'México', 'country': 'Mexico', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 31.00435, 'lon': -108.15213}}, {'zip': '2805-267', 'city': 'Almada', 'country': 'Portugal', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 38.67902, 'lon': -9.1569}}, {'zip': '2700', 'city': 'Amadora', 'country': 'Portugal', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 38.75382, 'lon': -9.23083}}, {'zip': '1649-035', 'city': 'Lisbon', 'country': 'Portugal', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'zip': '00935', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}, {'zip': '105275', 'city': 'Moscow', 'country': 'Russia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '129110', 'city': 'Moscow', 'country': 'Russia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '196645', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '4013', 'city': 'Durban', 'state': 'KwaZulu-Natal', 'country': 'South Africa', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': -29.8579, 'lon': 31.0292}}, {'zip': '7505', 'city': 'Parow Valley', 'state': 'Western Province', 'country': 'South Africa', 'facility': 'GSK Investigational Site'}, {'zip': '2013', 'city': 'Soweto', 'country': 'South Africa', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': -26.26781, 'lon': 27.85849}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'ViiV Healthcare'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ViiV Healthcare', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}