Ignite Creation Date:
2025-12-24 @ 3:33 PM
Ignite Modification Date:
2026-02-02 @ 11:48 AM
Study NCT ID:
NCT00383292
Status:
COMPLETED
Last Update Posted:
2018-06-06
First Post:
2006-09-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Tasisulam in Treating Participants With Malignant Melanoma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C534068', 'term': 'N-((5-bromo-2-thienyl)sulfonyl)-2,4-dichlorobenzamide'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Tasisulam Dose Target 420 μg/mL Cmax', 'description': 'Tasisulam loading dose targeting 420 μg/mL maximum concentration at the end of infusion (Cmax) administered as a 2-hour intravenous (IV) infusion on Day 1 of Cycle 1, followed by a chronic dose of 65% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks).', 'otherNumAtRisk': 68, 'otherNumAffected': 58, 'seriousNumAtRisk': 68, 'seriousNumAffected': 24}, {'id': 'EG001', 'title': 'Tasisulam Dose Target 360 μg/mL Cmax', 'description': 'Tasisulam loading dose targeting 360 μg/mL Cmax was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by a chronic dose of 90% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks).', 'otherNumAtRisk': 32, 'otherNumAffected': 31, 'seriousNumAtRisk': 32, 'seriousNumAffected': 13}, {'id': 'EG002', 'title': 'Tasisulam Albumin-Tailored Dose', 'description': 'Tasisulam dose tailored to lean body weight (LBW) and pre-cycle albumin levels (≤420 μg/mL Cmax) was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by chronic dosing ranging from 65% to 90% of the loading dose (tailored by the predose serum albumin for that cycle) on Day 1 of subsequent 28-day cycles (every four weeks).', 'otherNumAtRisk': 30, 'otherNumAffected': 29, 'seriousNumAtRisk': 30, 'seriousNumAffected': 11}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 100, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 21, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 34, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 46, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 36, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 25, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 6, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 62, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 19, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 48, 'numAffected': 11}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 15, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 25, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 22, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 25, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 8, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 20, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 45, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 22, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 15, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 62, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 67, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 21, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 59, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 9, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 50, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 12, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 74, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 38, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 9, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 43, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 15, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 15, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Axillary pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 11, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 249, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 94, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 71, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Infusion site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 14, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 11, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 56, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 13, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 36, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 19, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 23, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 10, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 12, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 16, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 9, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 12, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 18, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 5, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 20, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 20, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 11, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 6, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 13, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 8, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 6, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 20, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 15, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 15, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 11, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 22, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 20, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 19, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 13, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 6, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 24, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 11, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 46, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 32, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 21, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 13, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 9, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 15, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 100, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 9, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 45, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 7, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Bacterial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Biliary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Paronychia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Procedural complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 9, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Joint swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Aphasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cerebral artery thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Haemorrhagic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Peripheral motor neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Spinal cord compression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hydronephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 32, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Achieving Objective Response Rate (ORR) (Complete Response + Partial Response)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tasisulam Dose Target 420 μg/mL Cmax', 'description': 'Tasisulam loading dose targeting 420 μg/mL maximum concentration at the end of infusion (Cmax) administered as a 2-hour intravenous (IV) infusion on Day 1 of Cycle 1, followed by a chronic dose of 65% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks).'}, {'id': 'OG001', 'title': 'Tasisulam Dose Target 360 μg/mL Cmax', 'description': 'Tasisulam loading dose targeting 360 μg/mL Cmax was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by a chronic dose of 90% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks).'}, {'id': 'OG002', 'title': 'Tasisulam Albumin-Tailored Dose', 'description': 'Tasisulam dose tailored to lean body weight (LBW) and pre-cycle albumin levels (≤420 μg/mL Cmax) was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by chronic dosing ranging from 65% to 90% of the loading dose (tailored by the predose serum albumin for that cycle) on Day 1 of subsequent 28-day cycles (every four weeks).'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '20'}, {'value': '6', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '10'}, {'value': '7', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '10'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Measured Progressive Disease (up to 60 Months)', 'description': "Participants achieved an objective response if they had a best overall response of complete response (CR) or partial response (PR). According to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1), CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to \\<10 mm, the disappearance of all non-target lesions, and the normalization of tumor marker levels (if tumor markers were initially above the upper limit of normal); PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter. For each participant who is not known to have died or to have had objective progression of disease as of the data-inclusion cut-off date for a particular analysis, duration of tumor response was to be censored at the date of the participant's last objective tumor assessment prior to that cut-off date.", 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Progression-Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tasisulam Dose Target 420 μg/mL Cmax', 'description': 'Tasisulam loading dose targeting 420 μg/mL maximum concentration at the end of infusion (Cmax) administered as a 2-hour intravenous (IV) infusion on Day 1 of Cycle 1, followed by a chronic dose of 65% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks).'}, {'id': 'OG001', 'title': 'Tasisulam Dose Target 360 μg/mL Cmax', 'description': 'Tasisulam loading dose targeting 360 μg/mL Cmax was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by a chronic dose of 90% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks).'}, {'id': 'OG002', 'title': 'Tasisulam Albumin-Tailored Dose', 'description': 'Tasisulam dose tailored to lean body weight (LBW) and pre-cycle albumin levels (≤420 μg/mL Cmax) was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by chronic dosing ranging from 65% to 90% of the loading dose (tailored by the predose serum albumin for that cycle) on Day 1 of subsequent 28-day cycles (every four weeks).'}], 'classes': [{'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '4.3'}, {'value': '2.8', 'groupId': 'OG001', 'lowerLimit': '1.4', 'upperLimit': '5.7'}, {'value': '3.5', 'groupId': 'OG002', 'lowerLimit': '1.9', 'upperLimit': '5.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to Measured Progressive Disease or Death from Any Cause (up to 42 Months)', 'description': "PFS was defined as the time from baseline until measured PD or death from any cause, whichever is first. According to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1), PD was at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the 20% relative increase, the sum must have also demonstrated an absolute increase of at least 5 millimeters (mm). The appearance of 1 or more new lesions and/or unequivocal progression of existing nontarget lesions was also considered progression. Participants without objectively determined PD, who were alive at the end of the follow-up period (or lost to follow-up), were censored on the date of the participant's last complete radiographic tumor assessment; if no baseline or post-baseline radiologic assessment was available, the participant was censored at the date of randomization.", 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug. Participants censored: Tasisulam Target Cmax 420 µg/mL = 10, Tasisulam Target Cmax 360 µg/mL = 8, Albumin-Tailored Dose = 8.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Complete Response (CR), Partial Response (PR), or Stable Disease (SD) (Clinical Response Rate)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tasisulam Dose Target 420 μg/mL Cmax', 'description': 'Tasisulam loading dose targeting 420 μg/mL maximum concentration at the end of infusion (Cmax) administered as a 2-hour intravenous (IV) infusion on Day 1 of Cycle 1, followed by a chronic dose of 65% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks).'}, {'id': 'OG001', 'title': 'Tasisulam Dose Target 360 μg/mL Cmax', 'description': 'Tasisulam loading dose targeting 360 μg/mL Cmax was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by a chronic dose of 90% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks).'}, {'id': 'OG002', 'title': 'Tasisulam Albumin-Tailored Dose', 'description': 'Tasisulam dose tailored to lean body weight (LBW) and pre-cycle albumin levels (≤420 μg/mL Cmax) was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by chronic dosing ranging from 65% to 90% of the loading dose (tailored by the predose serum albumin for that cycle) on Day 1 of subsequent 28-day cycles (every four weeks).'}], 'classes': [{'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000', 'lowerLimit': '40', 'upperLimit': '60'}, {'value': '47', 'groupId': 'OG001', 'lowerLimit': '30', 'upperLimit': '60'}, {'value': '50', 'groupId': 'OG002', 'lowerLimit': '30', 'upperLimit': '70'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Progressive Disease or Death Due to Any Cause (up to 60 Months)', 'description': 'Participants achieved disease control if they had a best overall response of PR, CR or SD. According to RECIST v1.1, CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to \\<10 mm, the disappearance of all non-target lesions, and the normalization of tumor marker levels (if tumor markers were initially above the upper limit of normal \\[ULN\\]); PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter. SD was neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD, taking as reference the smallest sum diameter since treatment started. Clinical Response Rate was calculated as the number of participants who were free from progression (CR+PR+SD) for ≥2 cycles/number of participants who received at least 1 dose of tasisulam.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics: Plasma Clearance Rate of Tasisulam', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tasisulam', 'description': "Tasisulam dose is dependent on participant's height, weight, and gender and is adjusted to target a specific Cmax based on participant laboratory parameters. Participants will receive a 2-hour intravenous infusion of study drug once every 28 days."}], 'classes': [{'categories': [{'measurements': [{'value': '0.0275', 'spread': '3.57', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle 1-3, Day 1, 8 and 15: Predose, End of Infusion, and Postinfusion', 'unitOfMeasure': 'Liters/hour (L/h)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug and had evaluable PK data. PK analysis were performed on combined arms for total drug per protocol.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS) Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tasisulam Dose Target 420 μg/mL Cmax', 'description': 'Tasisulam loading dose targeting 420 μg/mL maximum concentration at the end of infusion (Cmax) administered as a 2-hour intravenous (IV) infusion on Day 1 of Cycle 1, followed by a chronic dose of 65% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks).'}, {'id': 'OG001', 'title': 'Tasisulam Dose Target 360 μg/mL Cmax', 'description': 'Tasisulam loading dose targeting 360 μg/mL Cmax was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by a chronic dose of 90% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks).'}, {'id': 'OG002', 'title': 'Tasisulam Albumin-Tailored Dose', 'description': 'Tasisulam dose tailored to lean body weight (LBW) and pre-cycle albumin levels (≤420 μg/mL Cmax) was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by chronic dosing ranging from 65% to 90% of the loading dose (tailored by the predose serum albumin for that cycle) on Day 1 of subsequent 28-day cycles (every four weeks).'}], 'classes': [{'categories': [{'measurements': [{'value': '10.5', 'groupId': 'OG000', 'lowerLimit': '7.4', 'upperLimit': '12.6'}, {'value': '11.9', 'comment': 'Not estimable based on insufficient number of participants with event data.', 'groupId': 'OG001', 'lowerLimit': '7.1', 'upperLimit': 'NA'}, {'value': '20.1', 'groupId': 'OG002', 'lowerLimit': '11.2', 'upperLimit': '22.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to Death from Any Cause (up to 42 Months)', 'description': 'OS was defined as time from baseline to the date of death from any cause. Participants who were alive at the end of the follow-up period (or lost to follow-up) were censored on the last date the participant was known to be alive.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug. Participants censored: Tasisulam Target Cmax 420 µg/mL = 25, Tasisulam Target Cmax 360 µg/mL = 17, Albumin-Tailored Dose = 17.'}, {'type': 'SECONDARY', 'title': 'Duration of Overall Objective Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tasisulam Dose Target 420 μg/mL Cmax', 'description': 'Tasisulam loading dose targeting 420 μg/mL maximum concentration at the end of infusion (Cmax) administered as a 2-hour intravenous (IV) infusion on Day 1 of Cycle 1, followed by a chronic dose of 65% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks).'}, {'id': 'OG001', 'title': 'Tasisulam Dose Target 360 μg/mL Cmax', 'description': 'Tasisulam loading dose targeting 360 μg/mL Cmax was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by a chronic dose of 90% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks).'}, {'id': 'OG002', 'title': 'Tasisulam Albumin-Tailored Dose', 'description': 'Tasisulam dose tailored to lean body weight (LBW) and pre-cycle albumin levels (≤420 μg/mL Cmax) was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by chronic dosing ranging from 65% to 90% of the loading dose (tailored by the predose serum albumin for that cycle) on Day 1 of subsequent 28-day cycles (every four weeks).'}], 'classes': [{'categories': [{'measurements': [{'value': '5.6', 'groupId': 'OG000', 'lowerLimit': '4.3', 'upperLimit': '16.1'}, {'value': '7.2', 'comment': 'Not estimable based on insufficient number of participants with event data.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '4.1', 'groupId': 'OG002', 'lowerLimit': '3.5', 'upperLimit': '4.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Date of Response to Date of Measured PD (up to 1 Year)', 'description': 'The duration of response was measured from the date of CR or PR to first date of documented PD or death and was censored at the date of the last assessment for responders who remained alive and did not have documented PD.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug. Participants censored: Tasisulam Target Cmax 420 µg/mL = 1, Tasisulam Target Cmax 360 µg/mL = 1, Albumin-Tailored Dose = 0.'}, {'type': 'SECONDARY', 'title': 'Duration of Stable Disease (SD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tasisulam Dose Target 420 μg/mL Cmax', 'description': 'Tasisulam loading dose targeting 420 μg/mL maximum concentration at the end of infusion (Cmax) administered as a 2-hour intravenous (IV) infusion on Day 1 of Cycle 1, followed by a chronic dose of 65% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks).'}, {'id': 'OG001', 'title': 'Tasisulam Dose Target 360 μg/mL Cmax', 'description': 'Tasisulam loading dose targeting 360 μg/mL Cmax was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by a chronic dose of 90% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks).'}, {'id': 'OG002', 'title': 'Tasisulam Albumin-Tailored Dose', 'description': 'Tasisulam dose tailored to lean body weight (LBW) and pre-cycle albumin levels (≤420 μg/mL Cmax) was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by chronic dosing ranging from 65% to 90% of the loading dose (tailored by the predose serum albumin for that cycle) on Day 1 of subsequent 28-day cycles (every four weeks).'}], 'classes': [{'categories': [{'measurements': [{'value': '6.9', 'groupId': 'OG000', 'lowerLimit': '4.1', 'upperLimit': '8.0'}, {'value': '6.4', 'groupId': 'OG001', 'lowerLimit': '2.8', 'upperLimit': '7.5'}, {'value': '5.7', 'groupId': 'OG002', 'lowerLimit': '3.8', 'upperLimit': '6.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to Progressive Disease or Death Due to Any Cause (up to 1 Year)', 'description': 'Duration of SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameters while on study. SD is measured at the start of the study drug until progressive disease or death due to any cause, whichever is first. Censoring occurred if a participant did not have a complete baseline disease assessment, initiated on another anti-cancer therapy (censored at the date of the last complete objective progression-free disease assessment before initiation of the new therapy), was not known to have died or had objective progression as of the data inclusion cutoff date for analysis.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug. Participants censored: Tasisulam Target Cmax 420 µg/mL = 6, Tasisulam Target Cmax 360 µg/mL = 5, Albumin-Tailored Dose = 5.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration (Safety: Adverse Events)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Tasisulam Dose Target 420 μg/mL Cmax', 'description': 'Tasisulam loading dose targeting 420 μg/mL maximum concentration at the end of infusion (Cmax) administered as a 2-hour intravenous (IV) infusion on Day 1 of Cycle 1, followed by a chronic dose of 65% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks).'}, {'id': 'OG001', 'title': 'Tasisulam Dose Target 360 μg/mL Cmax', 'description': 'Tasisulam loading dose targeting 360 μg/mL Cmax was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by a chronic dose of 90% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks).'}, {'id': 'OG002', 'title': 'Tasisulam Albumin-Tailored Dose', 'description': 'Tasisulam dose tailored to lean body weight (LBW) and pre-cycle albumin levels (≤420 μg/mL Cmax) was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by chronic dosing ranging from 65% to 90% of the loading dose (tailored by the predose serum albumin for that cycle) on Day 1 of subsequent 28-day cycles (every four weeks).'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to Study Completion (up to 60 Months)', 'description': 'Data presented are the number of participants who experienced SAEs considered by the investigator to be related to study drug administration. A summary of SAEs and all other non-serious Adverse Event(s) (AEs), regardless of causality, is located in the Reported Adverse Event module.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Health-Related Quality of Life: Functional Assessment of Cancer Therapy-General (FACT-G) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tasisulam', 'description': "Tasisulam dose is dependent on participant's height, weight, and gender and is adjusted to target a specific Cmax based on participant laboratory parameters. Participants will receive a 2-hour intravenous infusion of study drug once every 28 days."}], 'classes': [{'categories': [{'measurements': [{'value': '80.76', 'spread': '15.03', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Study Completion (up to 60 Months)', 'description': 'FACT-G is a 27-item compilation of general questions divided into 4 primary health-related quality of life (HRQL) domains: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. Total scores ranged from 0 to 172; higher scores = better HRQL.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug and had baseline and post baseline FACT-G data. FACT-G analysis was performed on combined arms per protocol.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tasisulam Dose Target 420 μg/mL Cmax', 'description': 'Tasisulam loading dose targeting 420 micrograms/milliliter (μg/mL) maximum concentration (Cmax) at the end of infusion administered as a 2-hour intravenous (IV) infusion on Day 1 of Cycle 1, followed by a chronic dose of 65% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks).'}, {'id': 'FG001', 'title': 'Tasisulam Dose Target 360 μg/mL Cmax', 'description': 'Tasisulam loading dose targeting 360 μg/mL Cmax was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by a chronic dose of 90% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks).'}, {'id': 'FG002', 'title': 'Tasisulam Albumin-Tailored Dose', 'description': 'Tasisulam dose tailored to lean body weight (LBW) and pre-cycle albumin levels (≤420 μg/mL Cmax) was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by chronic dosing ranging from 65% to 90% of the loading dose (tailored by the predose serum albumin for that cycle) on Day 1 of subsequent 28-day cycles (every four weeks).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '68'}, {'groupId': 'FG001', 'numSubjects': '32'}, {'groupId': 'FG002', 'numSubjects': '30'}]}, {'type': 'Received at Least One Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '68'}, {'groupId': 'FG001', 'numSubjects': '32'}, {'groupId': 'FG002', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '26'}, {'groupId': 'FG002', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Interim analyses of pharmacokinetic (PK) data resulted in adjusted dosing populations to achieve desired concentrations of study drug within the targeted range.', 'preAssignmentDetails': 'Study completion was defined as a participant completing 2 cycles of treatment and end of Cycle 2 radiographic assessment of response.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '130', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Tasisulam Dose Target 420 μg/mL Cmax', 'description': 'Tasisulam loading dose targeting 420 μg/mL maximum concentration at the end of infusion (Cmax) administered as a 2-hour intravenous (IV) infusion on Day 1 of Cycle 1, followed by a chronic dose of 65% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks).'}, {'id': 'BG001', 'title': 'Tasisulam Dose Target 360 μg/mL Cmax', 'description': 'Tasisulam loading dose targeting 360 μg/mL Cmax was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by a chronic dose of 90% of the loading dose on Day 1 of subsequent 21-day cycles (every three weeks).'}, {'id': 'BG002', 'title': 'Tasisulam Albumin-Tailored Dose', 'description': 'Tasisulam dose tailored to lean body weight (LBW) and pre-cycle albumin levels (≤420 μg/mL Cmax) was administered as a 2-hour IV infusion on Day 1 of Cycle 1, followed by chronic dosing ranging from 65% to 90% of the loading dose (tailored by the predose serum albumin for that cycle) on Day 1 of subsequent 28-day cycles (every four weeks).'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.03', 'spread': '12.68', 'groupId': 'BG000'}, {'value': '61.60', 'spread': '15.89', 'groupId': 'BG001'}, {'value': '61.35', 'spread': '11.69', 'groupId': 'BG002'}, {'value': '59.67', 'spread': '13.34', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '85', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '128', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '90', 'groupId': 'BG003'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All enrolled participants who received at least one dose of study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'dispFirstSubmitDate': '2012-02-10', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-04', 'studyFirstSubmitDate': '2006-09-29', 'dispFirstSubmitQcDate': '2012-02-10', 'resultsFirstSubmitDate': '2018-03-17', 'studyFirstSubmitQcDate': '2006-09-29', 'dispFirstPostDateStruct': {'date': '2012-02-14', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2018-06-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-05-04', 'studyFirstPostDateStruct': {'date': '2006-10-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Achieving Objective Response Rate (ORR) (Complete Response + Partial Response)', 'timeFrame': 'Baseline to Measured Progressive Disease (up to 60 Months)', 'description': "Participants achieved an objective response if they had a best overall response of complete response (CR) or partial response (PR). According to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1), CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to \\<10 mm, the disappearance of all non-target lesions, and the normalization of tumor marker levels (if tumor markers were initially above the upper limit of normal); PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter. For each participant who is not known to have died or to have had objective progression of disease as of the data-inclusion cut-off date for a particular analysis, duration of tumor response was to be censored at the date of the participant's last objective tumor assessment prior to that cut-off date."}], 'secondaryOutcomes': [{'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'Baseline to Measured Progressive Disease or Death from Any Cause (up to 42 Months)', 'description': "PFS was defined as the time from baseline until measured PD or death from any cause, whichever is first. According to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1), PD was at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the 20% relative increase, the sum must have also demonstrated an absolute increase of at least 5 millimeters (mm). The appearance of 1 or more new lesions and/or unequivocal progression of existing nontarget lesions was also considered progression. Participants without objectively determined PD, who were alive at the end of the follow-up period (or lost to follow-up), were censored on the date of the participant's last complete radiographic tumor assessment; if no baseline or post-baseline radiologic assessment was available, the participant was censored at the date of randomization."}, {'measure': 'Percentage of Participants Achieving Complete Response (CR), Partial Response (PR), or Stable Disease (SD) (Clinical Response Rate)', 'timeFrame': 'Baseline to Progressive Disease or Death Due to Any Cause (up to 60 Months)', 'description': 'Participants achieved disease control if they had a best overall response of PR, CR or SD. According to RECIST v1.1, CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to \\<10 mm, the disappearance of all non-target lesions, and the normalization of tumor marker levels (if tumor markers were initially above the upper limit of normal \\[ULN\\]); PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter. SD was neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD, taking as reference the smallest sum diameter since treatment started. Clinical Response Rate was calculated as the number of participants who were free from progression (CR+PR+SD) for ≥2 cycles/number of participants who received at least 1 dose of tasisulam.'}, {'measure': 'Pharmacokinetics: Plasma Clearance Rate of Tasisulam', 'timeFrame': 'Cycle 1-3, Day 1, 8 and 15: Predose, End of Infusion, and Postinfusion'}, {'measure': 'Overall Survival (OS) Time', 'timeFrame': 'Baseline to Death from Any Cause (up to 42 Months)', 'description': 'OS was defined as time from baseline to the date of death from any cause. Participants who were alive at the end of the follow-up period (or lost to follow-up) were censored on the last date the participant was known to be alive.'}, {'measure': 'Duration of Overall Objective Response', 'timeFrame': 'Date of Response to Date of Measured PD (up to 1 Year)', 'description': 'The duration of response was measured from the date of CR or PR to first date of documented PD or death and was censored at the date of the last assessment for responders who remained alive and did not have documented PD.'}, {'measure': 'Duration of Stable Disease (SD)', 'timeFrame': 'Baseline to Progressive Disease or Death Due to Any Cause (up to 1 Year)', 'description': 'Duration of SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameters while on study. SD is measured at the start of the study drug until progressive disease or death due to any cause, whichever is first. Censoring occurred if a participant did not have a complete baseline disease assessment, initiated on another anti-cancer therapy (censored at the date of the last complete objective progression-free disease assessment before initiation of the new therapy), was not known to have died or had objective progression as of the data inclusion cutoff date for analysis.'}, {'measure': 'Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration (Safety: Adverse Events)', 'timeFrame': 'Baseline to Study Completion (up to 60 Months)', 'description': 'Data presented are the number of participants who experienced SAEs considered by the investigator to be related to study drug administration. A summary of SAEs and all other non-serious Adverse Event(s) (AEs), regardless of causality, is located in the Reported Adverse Event module.'}, {'measure': 'Health-Related Quality of Life: Functional Assessment of Cancer Therapy-General (FACT-G) Score', 'timeFrame': 'Baseline to Study Completion (up to 60 Months)', 'description': 'FACT-G is a 27-item compilation of general questions divided into 4 primary health-related quality of life (HRQL) domains: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. Total scores ranged from 0 to 172; higher scores = better HRQL.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Metastatic Melanoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.lillytrials.com', 'label': 'Lilly Clinical Trial Registry'}]}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to determine the objective response rate (complete and partial response) for participants who receive tasisulam after one prior systemic treatment for unresectable or metastatic melanoma.', 'detailedDescription': 'Participants will receive a 2-hour intravenous infusion of study drug (tasisulam) once every 28 days. Radiological imaging scans will be performed before the first dose of study drug and then after every other treatment. Participants will be assessed for clinical progression at every visit and for response approximately every 56 days (every other cycle).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of malignant melanoma that is unresectable or metastatic (Stage III or IV)\n* Have received 1 previous systemic treatment regimen for unresectable or metastatic melanoma. An immunotherapy or antibody-based regimen (including vaccination-based treatments) is not counted as a prior treatment regimen for determining study eligibility, unless it was combined with a chemotherapeutic or targeted anti-cancer drug.\n* Have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, immunotherapy, or other investigational therapy for at least 30 days\n\nExclusion Criteria:\n\n* Serious pre-existing medical conditions\n* Have received two or more previous treatment regimens for unresectable or metastatic melanoma\n* Have a second primary cancer (unless disease-free to more than 2 years)\n* Active treatment with Warfarin (Coumadin)\n* Primary ocular or mucosal melanoma'}, 'identificationModule': {'nctId': 'NCT00383292', 'briefTitle': 'A Study of Tasisulam in Treating Participants With Malignant Melanoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Phase 2 Study of LY573636 Administered as an Intravenous Infusion on Day 1 of a 28-Day Cycle as Second-Line Treatment in Patients With Unresectable or Metastatic Melanoma', 'orgStudyIdInfo': {'id': '10409'}, 'secondaryIdInfos': [{'id': 'H8K-MC-JZAF', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tasisulam', 'interventionNames': ['Drug: tasisulam']}], 'interventions': [{'name': 'tasisulam', 'type': 'DRUG', 'otherNames': ['LY573636'], 'description': "Tasisulam dose is dependent on participant's height, weight, and gender and is adjusted to target a specific Cmax based on participant laboratory parameters. Tasisulam is administered intravenously every 28 days until disease progression or other criteria for participant discontinuation are met.", 'armGroupLabels': ['Tasisulam']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90025', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '33805', 'city': 'Lakeland', 'state': 'Florida', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 28.03947, 'lon': -81.9498}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '87131', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '15232', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '38138', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '2450', 'city': 'Coffs Harbour', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': -30.29626, 'lon': 153.11351}}, {'zip': '2500', 'city': 'Wollongong', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': -34.424, 'lon': 150.89345}}, {'zip': '5000', 'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'zip': '5035', 'city': 'Ashford', 'state': 'South Australia', 'country': 'Australia', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': -34.94859, 'lon': 138.57457}}, {'zip': '6009', 'city': 'Nedlands', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': -31.98184, 'lon': 115.8073}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}