Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2025-12-25 @ 7:43 PM
Study NCT ID:
NCT00376935
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
2006-09-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Effectiveness of Palifermin in Increasing CD4 Counts in Treatment-Experienced HIV Infected Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Puerto Rico']}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D051523', 'term': 'Fibroblast Growth Factor 7'}], 'ancestors': [{'id': 'D005346', 'term': 'Fibroblast Growth Factors'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ACTGCT.Gov@s-3.com', 'phone': '(301) 628-3313', 'title': 'ACTG ClinicalTrials.gov Coordinator', 'organization': 'ACTG Network Coordinating Center, Social and Scientific Systems, Inc.'}, 'certainAgreement': {'otherDetails': 'Restriction Description:In accordance with the Clinical Trial Agreement between NIAID (DAIDS)and company collaborators,NIAID provides companies with a copy of any abstract,press release,or manuscript prior to submission for publication with sufficient time for company review and comment.The publication/other disclosure can be delayed for up to 30 additional business days for manuscripts and 5 business days for abstracts,to preserve U.S. or foreign patent or other intellectual property rights.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Palifermin Placebo', 'description': 'Participants will receive 3 placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.', 'otherNumAtRisk': 25, 'otherNumAffected': 25, 'seriousNumAtRisk': 25, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Palifermin (20 Mcg/kg)', 'description': 'Participants will receive 1 palifermin 20 mcg/kg (0.004) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.', 'otherNumAtRisk': 25, 'otherNumAffected': 24, 'seriousNumAtRisk': 25, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Palifermin (40 Mcg/kg)', 'description': 'Participants will receive 1 palifermin 40 mcg/kg (0.008) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.', 'otherNumAtRisk': 25, 'otherNumAffected': 25, 'seriousNumAtRisk': 25, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Palifermin (60 Mcg/kg)', 'description': 'Participants will receive 1 palifermin 60 mcg/kg (0.012) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.', 'otherNumAtRisk': 24, 'otherNumAffected': 24, 'seriousNumAtRisk': 24, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Eye pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Ocular hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hypoaesthesia oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Paraesthesia oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Tongue discolouration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Tongue disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Blood albumin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Blood bicarbonate', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Blood calcium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Blood cholesterol abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Blood glucose abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Blood glucose decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 16}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Blood phosphorus decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Blood potassium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Blood potassium increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Blood sodium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Blood sodium increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Carbon dioxide', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Carbon dioxide abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Paranasal sinus hypersecretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Sinus congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Generalised erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pruritus generalised', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Skin lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}], 'seriousEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Laryngeal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Absolute CD4+ Lymphocyte Counts From Baseline (Average of Pre-entry and Entry Values)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Palifermin Placebo', 'description': 'Participants will receive 3 placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.'}, {'id': 'OG001', 'title': 'Palifermin (20 mcg/kg)', 'description': 'Participants will receive 1 palifermin 20 mcg/kg (0.004) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.'}, {'id': 'OG002', 'title': 'Palifermin (40 mcg/kg)', 'description': 'Participants will receive 1 palifermin 40 mcg/kg (0.008) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.'}, {'id': 'OG003', 'title': 'Palifermin (60 mcg/kg)', 'description': 'Participants will receive 1 palifermin 60 mcg/kg (0.012) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000', 'lowerLimit': '-16', 'upperLimit': '23'}, {'value': '11', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '32'}, {'value': '12', 'groupId': 'OG002', 'lowerLimit': '-2', 'upperLimit': '25'}, {'value': '8', 'groupId': 'OG003', 'lowerLimit': '-13', 'upperLimit': '35'}]}]}], 'analyses': [{'pValue': '0.1996', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Shift parameter', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '98.4', 'paramValue': '-9', 'ciUpperLimit': '14', 'pValueComment': 'P-value reported here was not adjusted for multiple comparisons. A 98.4% confidence upper bound for the shift parameter for each comparison adjusted the multiple comparison issues and restricted the familywise Type I error rate at 0.05.', 'estimateComment': 'The shift parameter (say, X), was calculated as the difference between the distribution of the primary endpoint in the placebo arm and that of in the palifermin arm. X\\<0 indicates that palifermen is beneficial.', 'groupDescription': 'The null hypothesis is that the distribution of the change in absolute CD4+ lymphocyte counts from baseline to week 12 is the same in the placebo arm and palifermin (20 mcg/kg) arm. The 1-sided alternative hypothesis is that the endpoint distribution is shifted higher in the palifermin (20 mcg/kg) arm.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'One-sided Wilcoxon rank sum test was used to test the null hypothesis.A 98.4% confidence upper bound for the primary shift parameter was calculated.'}, {'pValue': '0.3135', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Shift parameter', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '98.4', 'paramValue': '-4', 'ciUpperLimit': '17', 'pValueComment': 'P-value reported here was not adjusted for multiple comparisons. A 98.4% confidence upper bound for the shift parameter for each comparison adjusted the multiple comparison issues and restricted the familywise Type I error rate at 0.05.', 'estimateComment': 'The shift parameter (say, X), was calculated as the difference between the distribution of the primary endpoint in the placebo arm and that of in the palifermin arm. X\\<0 indicates that palifermen is beneficial.', 'groupDescription': 'The null hypothesis is that the distribution of the change in absolute CD4+ lymphocyte counts from baseline to week 12 is the same in the placebo arm and palifermin (40 mcg/kg) arm. The 1-sided alternative hypothesis is that the endpoint distribution is shifted higher in the palifermin (40 mcg/kg) arm.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'One-sided Wilcoxon rank sum test was used to test the null hypothesis.A 98.4% confidence upper bound for the primary shift parameter was calculated.'}, {'pValue': '0.3662', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Shift parameter', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '98.4', 'paramValue': '-4', 'ciUpperLimit': '22', 'pValueComment': 'P-value reported here was not adjusted for multiple comparisons. A 98.4% confidence upper bound for the shift parameter for each comparison adjusted the multiple comparison issues and restricted the familywise Type I error rate at 0.05.', 'estimateComment': 'The shift parameter (say, X), was calculated as the difference between the distribution of the primary endpoint in the placebo arm and that of in the palifermin arm. X\\<0 indicates that palifermen is beneficial.', 'groupDescription': 'The null hypothesis is that the distribution of the change in absolute CD4+ lymphocyte counts from baseline to week 12 is the same in the placebo arm and palifermin (60 mcg/kg) arm. The 1-sided alternative hypothesis is that the endpoint distribution is shifted higher in the palifermin (60 mcg/kg) arm.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'One-sided Wilcoxon rank sum test was used to test the null hypothesis.A 98.4% confidence upper bound for the primary shift parameter was calculated.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-entry, entry, study week 12', 'description': 'Median and inter-quartile range of the change in absolute CD4 count from baseline to study week 12 were calculated for each treatment arm. Baseline CD4+ count was defined as the average of pre-entry and entry CD4 count. If one evaluation was missing, the other one was used. If a subject missed a week 12 CD4 count evaluation, then the CD4 count evaluation obtained after starting study treatment and closest in time to week 12 (using the earlier evaluation if necessary to break a tie) was used in place of the missing week 12 evaluation.', 'unitOfMeasure': 'cells/mm^3', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Numbers presented use the intent-to-treat.'}, {'type': 'SECONDARY', 'title': 'Qualitative Hepatitis C Virus RNA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Palifermin Placebo', 'description': 'Participants will receive 3 placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.'}, {'id': 'OG001', 'title': 'Palifermin (20 mcg/kg)', 'description': 'Participants will receive 1 palifermin 20 mcg/kg (0.004) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.'}, {'id': 'OG002', 'title': 'Palifermin (40 mcg/kg)', 'description': 'Participants will receive 1 palifermin 40 mcg/kg (0.008) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.'}, {'id': 'OG003', 'title': 'Palifermin (60 mcg/kg)', 'description': 'Participants will receive 1 palifermin 60 mcg/kg (0.012) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.'}], 'classes': [{'title': '# of participants who had positive HCV results', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': '# of participants who had negative HCV results', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}]}, {'title': '# of missing', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At study entry', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Grade 3 or 4 Toxicity for Signs and Symptoms From Randomization to Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Palifermin Placebo', 'description': 'Participants will receive 3 placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.'}, {'id': 'OG001', 'title': 'Palifermin (20 mcg/kg)', 'description': 'Participants will receive 1 palifermin 20 mcg/kg (0.004) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.'}, {'id': 'OG002', 'title': 'Palifermin (40 mcg/kg)', 'description': 'Participants will receive 1 palifermin 40 mcg/kg (0.008) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.'}, {'id': 'OG003', 'title': 'Palifermin (60 mcg/kg)', 'description': 'Participants will receive 1 palifermin 60 mcg/kg (0.012) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization to week 24', 'description': 'Number of subjects had a grade 3 or 4 toxicity for signs and symptoms. The toxicity grade scale has the following meaning: 1=mild, 2=moderate, 3=severe, 4=life-threatening.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Numbers presented use the intent-to-treat approach (i.e. ignoring changes from randomized treatment).'}, {'type': 'SECONDARY', 'title': 'Change in Naive CD4+ Cell Counts From Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Palifermin Placebo', 'description': 'Participants will receive 3 placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.'}, {'id': 'OG001', 'title': 'Palifermin (20 mcg/kg)', 'description': 'Participants will receive 1 palifermin 20 mcg/kg (0.004) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.'}, {'id': 'OG002', 'title': 'Palifermin (40 mcg/kg)', 'description': 'Participants will receive 1 palifermin 40 mcg/kg (0.008) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.'}, {'id': 'OG003', 'title': 'Palifermin (60 mcg/kg)', 'description': 'Participants will receive 1 palifermin 60 mcg/kg (0.012) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.'}], 'classes': [{'title': 'Day 2 naive CD4+ change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-2', 'groupId': 'OG000', 'lowerLimit': '-5', 'upperLimit': '2'}, {'value': '-2', 'groupId': 'OG001', 'lowerLimit': '-10', 'upperLimit': '3'}, {'value': '-1', 'groupId': 'OG002', 'lowerLimit': '-4', 'upperLimit': '2'}, {'value': '-2', 'groupId': 'OG003', 'lowerLimit': '-6', 'upperLimit': '1'}]}]}, {'title': 'Week 1 naive CD4+ change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-3', 'upperLimit': '4'}, {'value': '-2', 'groupId': 'OG001', 'lowerLimit': '-6', 'upperLimit': '2'}, {'value': '-1', 'groupId': 'OG002', 'lowerLimit': '-7', 'upperLimit': '2'}, {'value': '-1', 'groupId': 'OG003', 'lowerLimit': '-4', 'upperLimit': '2'}]}]}, {'title': 'Week 2 naive CD4+ change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1', 'groupId': 'OG000', 'lowerLimit': '-8', 'upperLimit': '4'}, {'value': '-1', 'groupId': 'OG001', 'lowerLimit': '-5', 'upperLimit': '2'}, {'value': '-1', 'groupId': 'OG002', 'lowerLimit': '-4', 'upperLimit': '3'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '-7', 'upperLimit': '3'}]}]}, {'title': 'Week 4 naive CD4+ change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-2', 'upperLimit': '4'}, {'value': '-2', 'groupId': 'OG001', 'lowerLimit': '-4', 'upperLimit': '1'}, {'value': '1', 'groupId': 'OG002', 'lowerLimit': '-4', 'upperLimit': '3'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '-3', 'upperLimit': '5'}]}]}, {'title': 'Week 8 naive CD4+ change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '-2', 'upperLimit': '7'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '-6', 'upperLimit': '3'}, {'value': '1', 'groupId': 'OG002', 'lowerLimit': '-3', 'upperLimit': '5'}, {'value': '2', 'groupId': 'OG003', 'lowerLimit': '-1', 'upperLimit': '7'}]}]}, {'title': 'Week 12 naive CD4+ change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '-6', 'upperLimit': '5'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '-7', 'upperLimit': '4'}, {'value': '1', 'groupId': 'OG002', 'lowerLimit': '-3', 'upperLimit': '5'}, {'value': '0', 'groupId': 'OG003', 'lowerLimit': '-6', 'upperLimit': '5'}]}]}, {'title': 'Week 24 naive CD4+ change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '-1', 'upperLimit': '10'}, {'value': '-1', 'groupId': 'OG001', 'lowerLimit': '-7', 'upperLimit': '4'}, {'value': '2', 'groupId': 'OG002', 'lowerLimit': '-4', 'upperLimit': '8'}, {'value': '1', 'groupId': 'OG003', 'lowerLimit': '-4', 'upperLimit': '7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'randomization, day 2, study weeks 1, 2, 4, 8, 12 and 24', 'unitOfMeasure': 'cells/mm^3', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was based on observed data only. No imputation was done for missing values. The number of participants with results available varies by study week for each treatment arm.'}, {'type': 'SECONDARY', 'title': 'Change in CT Thymic Index From Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Palifermin Placebo', 'description': 'Participants will receive 3 placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.'}, {'id': 'OG001', 'title': 'Palifermin (20 mcg/kg)', 'description': 'Participants will receive 1 palifermin 20 mcg/kg (0.004) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.'}, {'id': 'OG002', 'title': 'Palifermin (40 mcg/kg)', 'description': 'Participants will receive 1 palifermin 40 mcg/kg (0.008) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.'}, {'id': 'OG003', 'title': 'Palifermin (60 mcg/kg)', 'description': 'Participants will receive 1 palifermin 60 mcg/kg (0.012) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.'}], 'classes': [{'title': 'two-sizes-smaller thymus at week 12', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'one-size-smaller thymus at week 12', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'unchanged thymus from randomization to week 12', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}]}, {'title': 'one-size-larger thymus at week 12', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'two-sizes-larger thymus at week 12', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'randomization, study week 12', 'description': 'CT thymic index was evaluated at randomization and study week 12, ranging from 0 to 5 whereby 0 means lack of thymic tissue and an organ entirely replaced by fat, 1 means barely recognizable thymic tissue, 2 means minimal soft tissue, 3 means obvious thymic tissue, 4 means moderate thymic tissue, 5 means thymic mass of possible concern for thymoma. Change in CT thymic index from randomization to study week 12 was calculated for participants with both evaluations. The number of participants in each change group was reported by treatment arm.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who had CT thymus evaluations at both randomization and study week 12.'}, {'type': 'SECONDARY', 'title': 'Change in Absolute CD4+ Lymphocyte Counts From Randomization to Day 2, Weeks 1, 2, 4, 8, 12, 24.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Palifermin Placebo', 'description': 'Participants will receive 3 placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.'}, {'id': 'OG001', 'title': 'Palifermin (20 mcg/kg)', 'description': 'Participants will receive 1 palifermin 20 mcg/kg (0.004) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.'}, {'id': 'OG002', 'title': 'Palifermin (40 mcg/kg)', 'description': 'Participants will receive 1 palifermin 40 mcg/kg (0.008) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.'}, {'id': 'OG003', 'title': 'Palifermin (60 mcg/kg)', 'description': 'Participants will receive 1 palifermin 60 mcg/kg (0.012) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.'}], 'classes': [{'title': 'Day 2 CD4+ change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-4', 'groupId': 'OG000', 'lowerLimit': '-15', 'upperLimit': '22'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '-13', 'upperLimit': '15'}, {'value': '-12', 'groupId': 'OG002', 'lowerLimit': '-28', 'upperLimit': '1'}, {'value': '-5', 'groupId': 'OG003', 'lowerLimit': '-21', 'upperLimit': '16'}]}]}, {'title': 'Week 1 CD4+ change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '-10', 'upperLimit': '7'}, {'value': '-12', 'groupId': 'OG001', 'lowerLimit': '-31', 'upperLimit': '15'}, {'value': '-9', 'groupId': 'OG002', 'lowerLimit': '-33', 'upperLimit': '12'}, {'value': '6', 'groupId': 'OG003', 'lowerLimit': '-27', 'upperLimit': '22'}]}]}, {'title': 'Week 2 CD4+ change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1', 'groupId': 'OG000', 'lowerLimit': '-10', 'upperLimit': '37'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '-29', 'upperLimit': '9'}, {'value': '14', 'groupId': 'OG002', 'lowerLimit': '-3', 'upperLimit': '21'}, {'value': '2', 'groupId': 'OG003', 'lowerLimit': '-20', 'upperLimit': '26'}]}]}, {'title': 'Week 4 CD4+ change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000', 'lowerLimit': '-17', 'upperLimit': '25'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '-17', 'upperLimit': '9'}, {'value': '16', 'groupId': 'OG002', 'lowerLimit': '-15', 'upperLimit': '29'}, {'value': '2', 'groupId': 'OG003', 'lowerLimit': '-35', 'upperLimit': '28'}]}]}, {'title': 'Week 8 CD4+ change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000', 'lowerLimit': '-14', 'upperLimit': '26'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '-15', 'upperLimit': '20'}, {'value': '20', 'groupId': 'OG002', 'lowerLimit': '-5', 'upperLimit': '39'}, {'value': '9', 'groupId': 'OG003', 'lowerLimit': '-8', 'upperLimit': '32'}]}]}, {'title': 'Week 12 CD4+ change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '-17', 'upperLimit': '27'}, {'value': '11', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '32'}, {'value': '12', 'groupId': 'OG002', 'lowerLimit': '-6', 'upperLimit': '38'}, {'value': '8', 'groupId': 'OG003', 'lowerLimit': '-13', 'upperLimit': '35'}]}]}, {'title': 'Week 24 CD4+ change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '-10', 'upperLimit': '26'}, {'value': '8', 'groupId': 'OG001', 'lowerLimit': '-13', 'upperLimit': '34'}, {'value': '14', 'groupId': 'OG002', 'lowerLimit': '1', 'upperLimit': '50'}, {'value': '15', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '46'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'randomization, day 2, study weeks 1, 2, 4, 8, 12 and 24', 'unitOfMeasure': 'cells/mm^3', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was based on observed data only. No imputation was done for missing values. NOTE: The number of participants may vary in each study week for each treatment arm. The maximum number for each arm are showed above.'}, {'type': 'SECONDARY', 'title': 'Grade 3 or 4 Lab Toxicities From Randomization to Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Palifermin Placebo', 'description': 'Participants will receive 3 placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.'}, {'id': 'OG001', 'title': 'Palifermin (20 mcg/kg)', 'description': 'Participants will receive 1 palifermin 20 mcg/kg (0.004) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.'}, {'id': 'OG002', 'title': 'Palifermin (40 mcg/kg)', 'description': 'Participants will receive 1 palifermin 40 mcg/kg (0.008) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.'}, {'id': 'OG003', 'title': 'Palifermin (60 mcg/kg)', 'description': 'Participants will receive 1 palifermin 60 mcg/kg (0.012) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization to study week 24', 'description': 'Number of subjects had a grade 3 or 4 toxicity for laboratory abnormalities. The toxicity grade scale has the following meaning: 1=mild, 2=moderate, 3=severe, 4=life-threatening.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Death From Randomization to Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Palifermin Placebo', 'description': 'Participants will receive 3 placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.'}, {'id': 'OG001', 'title': 'Palifermin (20 mcg/kg)', 'description': 'Participants will receive 1 palifermin 20 mcg/kg (0.004) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.'}, {'id': 'OG002', 'title': 'Palifermin (40 mcg/kg)', 'description': 'Participants will receive 1 palifermin 40 mcg/kg (0.008) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.'}, {'id': 'OG003', 'title': 'Palifermin (60 mcg/kg)', 'description': 'Participants will receive 1 palifermin 60 mcg/kg (0.012) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization to week 24', 'description': 'Number of subjects died.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Palifermin Placebo', 'description': 'Participants will receive 3 placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.'}, {'id': 'FG001', 'title': 'Palifermin (20 mcg/kg)', 'description': 'Participants will receive 1 palifermin 20 mcg/kg (0.004) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.'}, {'id': 'FG002', 'title': 'Palifermin (40 mcg/kg)', 'description': 'Participants will receive 1 palifermin 40 mcg/kg (0.008) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.'}, {'id': 'FG003', 'title': 'Palifermin (60 mcg/kg)', 'description': 'Participants will receive 1 palifermin 60 mcg/kg (0.012) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '25'}, {'groupId': 'FG003', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '25'}, {'groupId': 'FG003', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Study participants were recruited at 22 sites around the States, between February 2007 to April 2008.', 'preAssignmentDetails': 'All randomized participants got at least one injection on each of three consecutive days.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '99', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Palifermin Placebo', 'description': 'Participants will receive 3 placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.'}, {'id': 'BG001', 'title': 'Palifermin (20 mcg/kg)', 'description': 'Participants will receive 1 palifermin 20 mcg/kg (0.004) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.'}, {'id': 'BG002', 'title': 'Palifermin (40 mcg/kg)', 'description': 'Participants will receive 1 palifermin 40 mcg/kg (0.008) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.'}, {'id': 'BG003', 'title': 'Palifermin (60 mcg/kg)', 'description': 'Participants will receive 1 palifermin 60 mcg/kg (0.012) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47', 'spread': '7.8', 'groupId': 'BG000', 'lowerLimit': '42', 'upperLimit': '50'}, {'value': '49', 'spread': '8.8', 'groupId': 'BG001', 'lowerLimit': '43', 'upperLimit': '54'}, {'value': '45', 'spread': '9.7', 'groupId': 'BG002', 'lowerLimit': '39', 'upperLimit': '54'}, {'value': '50', 'spread': '8.9', 'groupId': 'BG003', 'lowerLimit': '46', 'upperLimit': '57'}, {'value': '49', 'spread': '8.9', 'groupId': 'BG004', 'lowerLimit': '42', 'upperLimit': '55'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Age, Customized', 'classes': [{'title': 'Between 18 and 29 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}, {'title': 'Between 30 and 39 years', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}]}]}, {'title': 'Between 40 and 49 years', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '42', 'groupId': 'BG004'}]}]}, {'title': 'Between 50 and 59 years', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '27', 'groupId': 'BG004'}]}]}, {'title': 'Over 60 years', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '90', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White Non-Hispanic', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '52', 'groupId': 'BG004'}]}]}, {'title': 'Black Non-Hispanic', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '25', 'groupId': 'BG004'}]}]}, {'title': 'Hispanic (Regardless of Race)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}]}]}, {'title': 'Asian, Pacific Islander', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}, {'title': 'Missing/ Unknown', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '99', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'IV drug use', 'classes': [{'title': 'Never', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '81', 'groupId': 'BG004'}]}]}, {'title': 'Previously', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'CD4 count', 'classes': [{'categories': [{'measurements': [{'value': '147', 'groupId': 'BG000', 'lowerLimit': '110', 'upperLimit': '180'}, {'value': '155', 'groupId': 'BG001', 'lowerLimit': '126', 'upperLimit': '194'}, {'value': '156', 'groupId': 'BG002', 'lowerLimit': '116', 'upperLimit': '197'}, {'value': '152', 'groupId': 'BG003', 'lowerLimit': '112', 'upperLimit': '192'}, {'value': '153', 'groupId': 'BG004', 'lowerLimit': '116', 'upperLimit': '194'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'cell/mm^3', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'CD8 count', 'classes': [{'categories': [{'measurements': [{'value': '638', 'groupId': 'BG000', 'lowerLimit': '394', 'upperLimit': '887'}, {'value': '615', 'groupId': 'BG001', 'lowerLimit': '464', 'upperLimit': '722'}, {'value': '716', 'groupId': 'BG002', 'lowerLimit': '575', 'upperLimit': '999'}, {'value': '761', 'groupId': 'BG003', 'lowerLimit': '502', 'upperLimit': '1099'}, {'value': '665', 'groupId': 'BG004', 'lowerLimit': '467', 'upperLimit': '954'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'cell/mm^3', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'HIV-1 RNA Categorical', 'classes': [{'title': '< 50 copies/mL', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '91', 'groupId': 'BG004'}]}]}, {'title': '= 52 copies/mL', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}, {'title': '= 77 copies/mL', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}, {'title': '= 81 copies/mL', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}, {'title': '= 84 copies/mL', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}, {'title': '= 88 copies/mL', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}, {'title': '= 97 copies/mL', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}, {'title': '= 69440 copies/mL', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 99}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'dispFirstSubmitDate': '2009-10-20', 'completionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-02', 'studyFirstSubmitDate': '2006-09-14', 'dispFirstSubmitQcDate': '2009-10-20', 'resultsFirstSubmitDate': '2011-10-04', 'studyFirstSubmitQcDate': '2006-09-14', 'dispFirstPostDateStruct': {'date': '2009-10-22', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2021-11-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2011-12-22', 'studyFirstPostDateStruct': {'date': '2006-09-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-01-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Absolute CD4+ Lymphocyte Counts From Baseline (Average of Pre-entry and Entry Values)', 'timeFrame': 'Pre-entry, entry, study week 12', 'description': 'Median and inter-quartile range of the change in absolute CD4 count from baseline to study week 12 were calculated for each treatment arm. Baseline CD4+ count was defined as the average of pre-entry and entry CD4 count. If one evaluation was missing, the other one was used. If a subject missed a week 12 CD4 count evaluation, then the CD4 count evaluation obtained after starting study treatment and closest in time to week 12 (using the earlier evaluation if necessary to break a tie) was used in place of the missing week 12 evaluation.'}], 'secondaryOutcomes': [{'measure': 'Qualitative Hepatitis C Virus RNA', 'timeFrame': 'At study entry'}, {'measure': 'Grade 3 or 4 Toxicity for Signs and Symptoms From Randomization to Week 24', 'timeFrame': 'From randomization to week 24', 'description': 'Number of subjects had a grade 3 or 4 toxicity for signs and symptoms. The toxicity grade scale has the following meaning: 1=mild, 2=moderate, 3=severe, 4=life-threatening.'}, {'measure': 'Change in Naive CD4+ Cell Counts From Randomization', 'timeFrame': 'randomization, day 2, study weeks 1, 2, 4, 8, 12 and 24'}, {'measure': 'Change in CT Thymic Index From Randomization', 'timeFrame': 'randomization, study week 12', 'description': 'CT thymic index was evaluated at randomization and study week 12, ranging from 0 to 5 whereby 0 means lack of thymic tissue and an organ entirely replaced by fat, 1 means barely recognizable thymic tissue, 2 means minimal soft tissue, 3 means obvious thymic tissue, 4 means moderate thymic tissue, 5 means thymic mass of possible concern for thymoma. Change in CT thymic index from randomization to study week 12 was calculated for participants with both evaluations. The number of participants in each change group was reported by treatment arm.'}, {'measure': 'Change in Absolute CD4+ Lymphocyte Counts From Randomization to Day 2, Weeks 1, 2, 4, 8, 12, 24.', 'timeFrame': 'randomization, day 2, study weeks 1, 2, 4, 8, 12 and 24'}, {'measure': 'Grade 3 or 4 Lab Toxicities From Randomization to Week 24', 'timeFrame': 'From randomization to study week 24', 'description': 'Number of subjects had a grade 3 or 4 toxicity for laboratory abnormalities. The toxicity grade scale has the following meaning: 1=mild, 2=moderate, 3=severe, 4=life-threatening.'}, {'measure': 'Number of Death From Randomization to Week 24', 'timeFrame': 'From randomization to week 24', 'description': 'Number of subjects died.'}]}, 'conditionsModule': {'keywords': ['Treatment Experienced'], 'conditions': ['HIV Infections']}, 'referencesModule': {'references': [{'pmid': '16848276', 'type': 'BACKGROUND', 'citation': 'Aiuti F, Mezzaroma I. Failure to reconstitute CD4+ T-cells despite suppression of HIV replication under HAART. AIDS Rev. 2006 Apr-Jun;8(2):88-97.'}, {'pmid': '11986226', 'type': 'BACKGROUND', 'citation': 'Franco JM, Rubio A, Martinez-Moya M, Leal M, Merchante E, Sanchez-Quijano A, Lissen E. T-cell repopulation and thymic volume in HIV-1-infected adult patients after highly active antiretroviral therapy. Blood. 2002 May 15;99(10):3702-6. doi: 10.1182/blood.v99.10.3702.'}, {'pmid': '15516965', 'type': 'BACKGROUND', 'citation': 'van den Brink MR, Alpdogan O, Boyd RL. Strategies to enhance T-cell reconstitution in immunocompromised patients. Nat Rev Immunol. 2004 Nov;4(11):856-67. doi: 10.1038/nri1484.'}, {'pmid': '12672400', 'type': 'BACKGROUND', 'citation': 'Ye P, Kourtis AP, Kirschner DE. Reconstitution of thymic function in HIV-1 patients treated with highly active antiretroviral therapy. Clin Immunol. 2003 Feb;106(2):95-105. doi: 10.1016/s1521-6616(02)00024-4.'}]}, 'descriptionModule': {'briefSummary': 'Palifermin is a modified version of a naturally occurring human growth factor that is currently approved by the FDA to treat blood cancers. The purpose of this study is to determine whether palifermin can increase CD4 counts in treatment-experienced HIV infected adults.', 'detailedDescription': 'Antiretroviral therapy (ART) has dramatically improved the clinical outcome for HIV infected adults; however, some people on potent ART experience poor recovery of CD4 counts despite maximum suppression of viral load. Such uncontrolled HIV infection is associated with the reduced ability by the human body to create new T cells (or thymopoiesis). HIV infected adults experiencing reduced thymopoiesis are at increased risk of clinical disease progression.\n\nThe thymus is the primary site for CD4 cell development; research suggests that keratinocyte growth factor (KGF) may enhance thymus activity in individuals who exhibit reduced thymopoiesis. Palifermin is a modified version of the naturally occurring KGF that is approved to treat people with hematologic malignancies. The purpose of this study is to evaluate the safety and efficacy of palifermin in increasing CD4 counts, through enhanced thymopoiesis, in treatment-experienced HIV infected adults with suppressed viral loads but low CD4 counts.\n\nThis study will last 24 weeks. Participants will be randomly assigned to one of four arms:\n\n* Arm A participants will receive placebo\n* Arm B participants will receive palifermin 20 mcg/kg\n* Arm C participants will receive palifermin 40 mcg/kg\n* Arm D participants will receive palifermin 60 mcg/kg\n\nParticipants will receive intravenous doses of their assigned intervention on Days 1, 2, and 3. All participants must remain on their current ART regimen for the duration of the study. ART will not be provided by the study. There will be six study visits, and they will occur at Weeks 1, 2, 4, 8, 12, and 24. All visits will include a targeted physical exam and blood and urine collection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV infected\n* Receiving potent ART, defined as a combination of three or more antiretroviral drugs for at least 6 months prior to study entry\n* CD4 count of 200 cells/mm3 or less within 30 days prior to study entry\n* Documented CD4 count obtained at study screening\n* Documented current, persistent viral load less than or equal to 200 copies/ml for at least 6 months prior to study entry\n* Willing to use acceptable forms of contraception for the duration of the study\n\nExclusion Criteria:\n\n* Active pancreatitis\n* Androgens, Immunomodulators (e.g., growth factors, systemic corticosteroids, HIV vaccines, immune globulin, interleukins, interferons), or investigational ART within 30 days prior to study entry\n* Systemic cancer chemotherapy within 30 days prior to study entry, or history of radiation therapy to the neck and chest regions at any time.\n* Allergy or sensitivity to any component of palifermin\n* Prior treatment with palifermin or other keratinocyte growth factors\n* Current drug or alcohol use that, in the opinion of the investigator, may interfere with study participation\n* Serious illness or recent surgery that requires systemic treatment or hospitalization. Participants who have completed therapy or are clinically stable on therapy for at least 30 days prior to study entry are not excluded.\n* Active cancer\n* HIV-1 RNA levels \\>200 copies/mL within 6 months prior to study entry\n* Pregnant or breastfeeding'}, 'identificationModule': {'nctId': 'NCT00376935', 'briefTitle': 'Effectiveness of Palifermin in Increasing CD4 Counts in Treatment-Experienced HIV Infected Adults', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Allergy and Infectious Diseases (NIAID)'}, 'officialTitle': 'A Double Blind Phase II Study of Multiple Doses of Palifermin (rHuKGF) for the Treatment of Inadequate CD4+ Lymphocyte Recovery in Subjects on Potent Antiretroviral Therapy With Plasma HIV-1 RNA Levels of 200 Copies Per Milliliter or Less', 'orgStudyIdInfo': {'id': 'A5212'}, 'secondaryIdInfos': [{'id': '10147', 'type': 'REGISTRY', 'domain': 'DAIDS ES'}, {'id': 'ACTG A5212'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '1', 'description': 'Participants will receive palifermin placebo injection on Days 1, 2, and 3', 'interventionNames': ['Drug: Palifermin placebo']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Participants will receive palifermin 20 mcg/kg injection on Days 1, 2, and 3', 'interventionNames': ['Drug: Palifermin']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'Participants will receive palifermin 40 mcg/kg injection on Days 1, 2, and 3', 'interventionNames': ['Drug: Palifermin']}, {'type': 'EXPERIMENTAL', 'label': '4', 'description': 'Participants will receive palifermin 60 mcg/kg injection on Days 1, 2, and 3', 'interventionNames': ['Drug: Palifermin']}], 'interventions': [{'name': 'Palifermin', 'type': 'DRUG', 'otherNames': ['rHuKGF'], 'description': 'Keratinocyte growth factor administered via injection', 'armGroupLabels': ['2', '3', '4']}, {'name': 'Palifermin placebo', 'type': 'DRUG', 'otherNames': ['rHuKGF placebo'], 'description': 'Keratinocyte growth factor placebo administered via injection', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'USC CRS', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90035', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA CARE Center CRS', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford CRS', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Ucsd, Avrc Crs', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '90502', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Harbor-UCLA Med. Ctr. CRS', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '33136-1013', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Univ. of Miami AIDS CRS', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'The Ponce de Leon Ctr. CRS', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'IHV Baltimore Treatment CRS', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Bmc Actg Crs', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '63108-2138', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington U CRS', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NY Univ. HIV/AIDS CRS', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032-3732', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia P&S CRS', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '14607', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Trillium Health ACTG CRS', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Univ. of Rochester ACTG CRS', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '27514', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Unc Aids Crs', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Univ. Med. Ctr. Adult CRS', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Case CRS', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '44109', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'MetroHealth CRS', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University Medical Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Hosp. of the Univ. of Pennsylvania CRS', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '37204', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt Therapeutics CRS', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington AIDS CRS', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Jeffrey M. Jacobson, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Division of Infectious Diseases and HIV Medicine, Drexel University College of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}, 'collaborators': [{'name': 'Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections', 'class': 'NETWORK'}], 'responsibleParty': {'type': 'SPONSOR'}}}}